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Safety of home-based cardiac rehabilitation: A systematic review

Open AccessPublished:May 07, 2022DOI:https://doi.org/10.1016/j.hrtlng.2022.04.016

      Highlights

      • This study identified a low rate of major exercise-related AEs in HBCR.
      • Half of the sample were patients classified with a high risk of exercise-related complications.
      • There were no cases of exercise-related deaths or hospitalizations in HBCR.
      • Low rates of AEs represent support for the implementation of HBCR programs.

      Abstract

      Background

      Cardiac rehabilitation is an evidence-based intervention that aims to improve health outcomes in cardiovascular disease patients, but it is largely underutilized. One strategy for improving utilization is home-based cardiac rehabilitation (HBCR). Previous research has shown that HBCR programs are feasible and effective. However, there is a lack of evidence on safety issues in different cardiac populations. This systematic review aimed to provide an evidence-based overview of the safety of HBCR.

      Objectives

      To examine the incidence and severity of adverse events of HBCR.

      Methods

      The following databases were searched: CINAHL, The Cochrane Library, Embase, MEDLINE, PubMed, Web of Science, Global Health, and Chinese BioMedical Literature Database for randomized controlled trials. The included trials were written in English and analyzed the incidence of adverse events (AEs) as a primary or secondary intervention outcome.

      Results

      Five studies showed AEs incidence, of which only one study reported severe AE associated with HBCR exercise. The incidence rate of severe AEs from the sample (n = 808) was estimated as 1 per 23,823 patient-hour of HBCR exercise. More than half patients included were stratified into a high-risk group. In the studies were found no deaths or hospitalizations related to HBCR exercise.

      Conclusion

      The risk of AEs during HBCR seems very low. Our results concerning the safety of HBCR should induce cardiac patients to be more active in their environment and practice physical exercise regularly.

      Keywords

      Abbreviations:

      AEs (adverse events), CBCR (centre-based cardiac rehabilitation), CR (cardiac rehabilitation), CVD (cardiovascular disease), HBCR (home-based cardiac rehabilitation), RCT (randomized controlled trial)

      Introduction

      Cardiovascular diseases (CVD) are the leading cause of death in today's society and the most common hospital admissions.
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      World Health Organization. WHO methods and data sources for global burden of disease estimates 2000-2019. Global Health Estimates Technical Paper WHO/ DDI/DNA/GHE/2020.3. https://cdn.who.int/media/docs/default-source/gho-documents/global-health-estimates/ghe2019_daly-methods.pdf?sfvrsn=31b25009_7. Published December, 2020. Accessed February 23, 2022.

      Cardiac rehabilitation (CR) is a multi-faceted, medically supervised intervention including baseline patient assessments, nutritional counseling, risk factor modification (management of lipids, blood pressure, weight, diabetes mellitus, and smoking cessation), psychosocial management, physical activity counseling, and exercise training, as well as other established core components of guideline-directed therapy.
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      CR is a procedure that provides faster recovery after a cardiac event, reduces cardiovascular mortality and hospitalization risk, and improves the health-related quality of life of the patients. However, it is significantly underutilized worldwide.
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      Therefore, new delivery strategies are needed to increase utilization. One potential strategy is the home-based CR approach (HBCR). Compared to the traditional center-based CR (CBCR) intervention, HBCR relies on remote monitoring and coaching with indirect exercise supervision.
      Furthermore, technological developments can potentially implement other appropriate alternatives to alleviate the limitations of traditional CBCR interventions by providing individual real-time assistance to patients in their home environment. In addition, it has been found that cardiovascular telerehabilitation can be an effective alternative to traditional CBCR.
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      • Batalik L.
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      Remotely monitored telerehabilitation for cardiac patients: a review of the current situation.
      Cardiac telerehabilitation offers advantages and disadvantages. Patients' adherence to CR programs increases with more independence, lower costs, and privacy; on the other hand, social isolation, digital technology literacy, and/or data security are CR barriers.
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      • et al.
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      • Nestor J.R.
      A controlled trial of cardiac rehabilitation in the home setting using electrocardiographic and voice transtelephonic monitoring.
      A Cochrane review by Anderson et al.
      • Anderson L.
      • Sharp G.A.
      • Norton R.J.
      • et al.
      Home-based versus centre-based cardiac rehabilitation.
      provided evidence that HBCR interventions are effective and are associated with improved blood pressure, cholesterol and depression scores, and cardiorespiratory fitness.
      • Anderson L.
      • Sharp G.A.
      • Norton R.J.
      • et al.
      Home-based versus centre-based cardiac rehabilitation.
      ,
      • Jafri S.H.
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      • Medbury E.
      • et al.
      Cardiovascular outcomes of patients referred to home based cardiac rehabilitation.
      Although delivery of HBCR interventions has been recently supported also by the American Association of Cardiovascular and Pulmonary Rehabilitation, the American Association of Cardiology, and the American Academy of Cardiology, however, safety issues remain unresolved, especially for the high-risk cardiac patients who are eligible for CR but cannot attend a traditional CBCR intervention.
      • Thomas R.J.
      • Beatty A.L.
      • Beckie T.M.
      • et al.
      Home-based cardiac rehabilitation: a scientific statement from the American Association of Cardiovascular and Pulmonary Rehabilitation, The American Heart Association, and the American College of Cardiology.
      Over the last decade, many studies have reported adverse cardiac events (AEs) during the implementation of an HBCR. Indeed, no studies have analyzed safety as a primary outcome yet. There were eight meta-analyses,
      • Anderson L.
      • Sharp G.A.
      • Norton R.J.
      • et al.
      Home-based versus centre-based cardiac rehabilitation.
      ,
      • Cavalheiro A.H.
      • Silva Cardoso J.
      • Rocha A.
      • Moreira E.
      • Azevedo L.F.
      Effectiveness of tele-rehabilitation programs in heart failure: a systematic review and meta-analysis.
      • Chan C.
      • Yamabayashi C.
      • Syed N.
      • Kirkham A.
      • Camp PG.
      Exercise telemonitoring and telerehabilitation compared with traditional cardiac and pulmonary rehabilitation: a systematic review and meta-analysis.
      • Huang K.
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      • He D.
      • et al.
      Telehealth interventions versus center-based cardiac rehabilitation of coronary artery disease: a systematic review and meta-analysis.
      • Jin K.
      • Khonsari S.
      • Gallagher R.
      • et al.
      Telehealth interventions for the secondary prevention of coronary heart disease: a systematic review and meta-analysis.
      • Ramachandran H.J.
      • Jiang Y.
      • Tam W.W.S.
      • Yeo T.J.
      • Wang W.
      Effectiveness of home-based cardiac telerehabilitation as an alternative to phase 2 cardiac rehabilitation of coronary heart disease: a systematic review and meta-analysis.
      • Rawstorn J.C.
      • Gant N.
      • Direito A.
      • Beckmann C.
      • Maddison R.
      Telehealth exercise-based cardiac rehabilitation: a systematic review and meta-analysis.
      • Zwisler A.D.
      • Norton R.J.
      • Dean S.G.
      • et al.
      Home-based cardiac rehabilitation for people with heart failure: a systematic review and meta-analysis.
      one systematic review,
      • Clark R.A.
      • Conway A.
      • Poulsen V.
      • Keech W.
      • Tirimacco R.
      • Tideman P.
      Alternative models of cardiac rehabilitation: a systematic review.
      and one scientific statement
      • Thomas R.J.
      • Beatty A.L.
      • Beckie T.M.
      • et al.
      Home-based cardiac rehabilitation: a scientific statement from the American Association of Cardiovascular and Pulmonary Rehabilitation, The American Heart Association, and the American College of Cardiology.
      that discussed the safety issue of the HBCR intervention (i.e., all-cause mortality, hospitalization-rehospitalization).
      This systematic review aimed to provide a scientific-evidence-based overview of the safety of HBCR. To the best of our knowledge, most of the studies included in the reviews, as mentioned above, did not fully incorporate detailed AEs outcomes. Therefore, these reports cannot give an evidence-based overview of the safety of HBCR exercises.

      Methods

      This systematic review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analysis criteria.
      • Moher D.
      • Liberati A.
      • Tetzlaff J.
      • Altman D.G.
      • Group P.
      Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.
      The International Prospective Record of Systematic Reviews, was used to register the study (CRD4202127221).

      Search strategy

      A systematic electronic literature search of randomized controlled trials (RCTs) was conducted using four databases: Medline, Embase, Chinese BioMedical Literature Database, and the Cochrane Central Register of Controlled Trials in the Cochrane Library. Manual searches were conducted on the reference lists and bibliographies of retrieved papers, review articles, relevant conference lists, and grey literature. RCTs published during 2000–2022 were chosen to synthesize this systematic review. Two independent reviewers read titles and abstracts to find papers that could be relevant. Papers were excluded for additional evaluation if the abstract did not include sufficient precise information or if such information was not accessible. Potentially relevant papers were retrieved in full-text and analyzed separately by two reviewers who agreed for inclusion based on the selection criteria below.

      Inclusion criteria

      The specific inclusion criteria for this review were: (a) randomized controlled trials; (b) implementation of a telehealth intervention or HBCR exercise-based program delivered by any following technology: telephone, computer, internet, or videoconferencing (c) one of the following outcomes had to be recorded: Safety of the intervention as a primary/secondary outcome, adverse or cardiac events, exercise or intervention related emergency calls or hospitalization. Table A.1 summarizes the searching keywords that were used.

      Extraction of adverse events evidence

      Based on the exercise intervention methodology of each study, we calculated the total number of patient hours of HBCR rehabilitation. One patient hour was determined as one completed exercise according to methodological prescription. For example, if exercise training was prescribed three times a week and the intervention lasted 12 weeks, 36 patient-hour of exercise were estimated. This estimation was updated according to reported exercise adherence.
      The degree of cardiovascular risk was extracted from each study included. A section of low, moderate, and high risk of CVD complications associated with exercise was used. AEs extracted were identified as mild or moderate-severe cardiac events that could lead to further hospitalization or emergency calls.
      • Gliklich R.E.
      • Dreyer N.A.
      • Leavy M.B.
      Registries for Evaluating Patient Outcomes: a User's Guide.
      Mortality was defined as a severe adverse event.
      • Smart N.A.
      • Waldron M.
      • Ismail H.
      • et al.
      Validation of a new tool for the assessment of study quality and reporting in exercise training studies: TESTEX.
      AEs were subsequently analyzed as exercise-related or not.

      Study quality estimation

      The methodological quality of the involved studies was evaluated throughout the TESTEX instrument.
      • Smart N.A.
      • Waldron M.
      • Ismail H.
      • et al.
      Validation of a new tool for the assessment of study quality and reporting in exercise training studies: TESTEX.
      The descriptive attributes per study were extracted, including the design, recruitment, and patient characteristics. In addition, descriptive data on the exercise program (duration of the intervention, duration of the exercise section, frequency, intensity of the exercise, attendance to the exercise prescription) were extracted. Moreover, the evaluation outcomes and the AEs of the intervention were extracted.
      The TESTEX instrument was preferred due to its reliability and suitability for exercise scientific research and complex review of exercise training interventions. The benefit of this instrument is in the possibility of optimizing the criteria for blinding participants or study investigators, which are discussable to implement in exercise-based interventions.
      The TESTEX contains 12 measures. A few measures can be assessed with more than 1 point, permitting a maximum of 15 points. A maximum of 5 points can be received for methodological quality, and 10 points can be received for study reporting. The studies were classified according to the average score as "high quality" (≥12 points), "good quality" (7 to 11 points), and "low quality" (≤6 points). The higher the score indicates, the better study and study reporting quality. High-quality interventions were described as highly appropriate, reproducible, and well methodically explained, with excellent results reporting.
      • Smart N.A.
      • Waldron M.
      • Ismail H.
      • et al.
      Validation of a new tool for the assessment of study quality and reporting in exercise training studies: TESTEX.
      Good-quality interventions were described as relatively relevant with some limitations in study results reporting and good reproducibility for future research. The low-quality interventions were described as significant limitations concerning the relevance of the method used with a lower reproducibility rate.
      Four essential elements of the methodological review were classified for all eligible studies:
      • the use of randomization for group allocation
      • the use of an unbiased randomization process
      • blinding of primary outcome evaluator
      • the use of intention-to-treat analysis

      Results

      Search and study selection results

      References and abstracts were imported into Endnote X20, and duplicates were removed. Fig. 1 outlines the literature search. Initial research identified a total number of 14,964 records of articles, in which 385 records remained after the exclusion of duplications, records that were marked as ineligible, and publications for research interest reasons. After a full-text review, 280 articles were excluded. Out of 105 articles that were sought for retrieval, 84 of them failed to be retrieved; thus leaving twenty-one records being assessed for eligibility. Finally, nine studies met the inclusion criteria to synthesize the present systematic review.
      • Snoek J.A.
      • Prescott E.I.
      • van der Velde A.E.
      • et al.
      Effectiveness of home-based mobile guided cardiac rehabilitation as alternative strategy for333 nonparticipation in clinic-based cardiac rehabilitation among elderly patients in Europe: a randomized clinical trial.
      • Taylor J.L.
      • Holland D.J.
      • Keating S.E.
      • et al.
      Short-term and long-term feasibility, safety, and efficacy of high-intensity interval training in cardiac rehabilitation: the FITR heart study randomized clinical trial.
      • Piotrowicz E.
      • Pencina M.J.
      • Opolski G.
      • et al.
      Effects of a 9-week hybrid comprehensive telerehabilitation program on long-term outcomes in patients with heart failure: the telerehabilitation in heart failure patients (TELEREH-HF) randomized clinical trial.
      • Batalik L.
      • Dosbaba F.
      • Hartman M.
      • Batalikova K.
      • Spinar J.
      Benefits and effectiveness of using a wrist heart rate monitor as a telerehabilitation device in cardiac patients: A randomized controlled trial.
      • Hwang R.
      • Bruning J.
      • Morris N.R.
      • Mandrusiak A.
      • Russell T.
      Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial.
      • Bravo-Escobar R.
      • González-Represas A.
      • Gómez-González A.M.
      • et al.
      Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: a randomised, controlled clinical trial.
      • Sibilitz K.L.
      • Berg S.K.
      • Rasmussen T.B.
      • et al.
      Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.
      • Piotrowicz E.
      • Baranowski R.
      • Bilinska M.
      • et al.
      A new model of home-based telemonitored cardiac rehabilitation in patients with heart failure: effectiveness, quality of life, and adherence.
      • Corvera-Tindel T.
      • Doering L.V.
      • Woo M.A.
      • Khan S.
      • Dracup K.
      Effects of a home walking exercise program on functional status and symptoms in heart failure.

      Study characteristics

      All the included studies were RCTs. The characteristics of patients and the outcomes are reported in Table B.1. Two studies from nine included were conducted in the United States
      • Taylor J.L.
      • Holland D.J.
      • Keating S.E.
      • et al.
      Short-term and long-term feasibility, safety, and efficacy of high-intensity interval training in cardiac rehabilitation: the FITR heart study randomized clinical trial.
      ,
      • Corvera-Tindel T.
      • Doering L.V.
      • Woo M.A.
      • Khan S.
      • Dracup K.
      Effects of a home walking exercise program on functional status and symptoms in heart failure.
      and Poland
      • Piotrowicz E.
      • Pencina M.J.
      • Opolski G.
      • et al.
      Effects of a 9-week hybrid comprehensive telerehabilitation program on long-term outcomes in patients with heart failure: the telerehabilitation in heart failure patients (TELEREH-HF) randomized clinical trial.
      ,
      • Piotrowicz E.
      • Baranowski R.
      • Bilinska M.
      • et al.
      A new model of home-based telemonitored cardiac rehabilitation in patients with heart failure: effectiveness, quality of life, and adherence.
      ; one each was conducted in the Netherlands,
      • Snoek J.A.
      • Prescott E.I.
      • van der Velde A.E.
      • et al.
      Effectiveness of home-based mobile guided cardiac rehabilitation as alternative strategy for333 nonparticipation in clinic-based cardiac rehabilitation among elderly patients in Europe: a randomized clinical trial.
      Czech Republic,
      • Batalik L.
      • Dosbaba F.
      • Hartman M.
      • Batalikova K.
      • Spinar J.
      Benefits and effectiveness of using a wrist heart rate monitor as a telerehabilitation device in cardiac patients: A randomized controlled trial.
      Australia,
      • Hwang R.
      • Bruning J.
      • Morris N.R.
      • Mandrusiak A.
      • Russell T.
      Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial.
      Spain,
      • Bravo-Escobar R.
      • González-Represas A.
      • Gómez-González A.M.
      • et al.
      Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: a randomised, controlled clinical trial.
      and in Danish.
      • Sibilitz K.L.
      • Berg S.K.
      • Rasmussen T.B.
      • et al.
      Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.
      Four included studies were published in the last five years,
      • Snoek J.A.
      • Prescott E.I.
      • van der Velde A.E.
      • et al.
      Effectiveness of home-based mobile guided cardiac rehabilitation as alternative strategy for333 nonparticipation in clinic-based cardiac rehabilitation among elderly patients in Europe: a randomized clinical trial.
      • Taylor J.L.
      • Holland D.J.
      • Keating S.E.
      • et al.
      Short-term and long-term feasibility, safety, and efficacy of high-intensity interval training in cardiac rehabilitation: the FITR heart study randomized clinical trial.
      • Piotrowicz E.
      • Pencina M.J.
      • Opolski G.
      • et al.
      Effects of a 9-week hybrid comprehensive telerehabilitation program on long-term outcomes in patients with heart failure: the telerehabilitation in heart failure patients (TELEREH-HF) randomized clinical trial.
      • Batalik L.
      • Dosbaba F.
      • Hartman M.
      • Batalikova K.
      • Spinar J.
      Benefits and effectiveness of using a wrist heart rate monitor as a telerehabilitation device in cardiac patients: A randomized controlled trial.
      and the other five were published before 2018. The sample size of HBCR patients ranged from 13 patients to 425 patients (total HBCR sample, n = 808), followed by an intervention period ranging from 8 weeks to 48 weeks (mostly a 12-week intervention model was used). Six studies included the active CBCR control group, and another five included a control group of patients with usual care. The prescription of HBCR exercise was prescribed in the frequency range from 2 sessions per week to daily exercise, with an exercise duration from 10 min to 60 min per session. In most HBCR interventions, the exercise intensity was prescribed from 60% to 80% heart rate reserve or from 9 to 13 ratings of perceived exertion.
      Exercise protocols included remote feedback and guidance provided throughout telephone calls, videoconferences, text messages, or personally by study specialists. Furthermore, the exercise intensity was monitored by electrocardiogram telemetry, wearable heart rate sensors, video platforms, or in-home nurses' visits. In three of nine included studies, exercise monitoring was provided in real-time.
      • Piotrowicz E.
      • Pencina M.J.
      • Opolski G.
      • et al.
      Effects of a 9-week hybrid comprehensive telerehabilitation program on long-term outcomes in patients with heart failure: the telerehabilitation in heart failure patients (TELEREH-HF) randomized clinical trial.
      ,
      • Hwang R.
      • Bruning J.
      • Morris N.R.
      • Mandrusiak A.
      • Russell T.
      Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial.
      ,
      • Piotrowicz E.
      • Baranowski R.
      • Bilinska M.
      • et al.
      A new model of home-based telemonitored cardiac rehabilitation in patients with heart failure: effectiveness, quality of life, and adherence.
      The RCTs' quality was assessed based on the TESTEX tool and showed a high-quality study design and study reporting (Table C.1), with a mean score of 12 points (range: 10–15 points). The study's quality was evaluated as high quality, with a mean score of 4 points (range: 3–5 points), and the study reporting quality showed good quality, with a mean score of 7 points (range: 6–10 points).
      • Smart N.A.
      • Waldron M.
      • Ismail H.
      • et al.
      Validation of a new tool for the assessment of study quality and reporting in exercise training studies: TESTEX.

      Methodological evaluation and analysis of the study quality

      For all eligible studies, an overall of four key methodological elements was evaluated (use of randomization for group allocation, use of the unbiased randomization method, blinding of assessors, and use of intention-to-treat analysis). The risk of bias assessment showed in Figs A.1, A.2.
      Three of the nine studies met all four quality assessment criteria in this review.
      • Taylor J.L.
      • Holland D.J.
      • Keating S.E.
      • et al.
      Short-term and long-term feasibility, safety, and efficacy of high-intensity interval training in cardiac rehabilitation: the FITR heart study randomized clinical trial.
      ,
      • Hwang R.
      • Bruning J.
      • Morris N.R.
      • Mandrusiak A.
      • Russell T.
      Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial.
      ,
      • Sibilitz K.L.
      • Berg S.K.
      • Rasmussen T.B.
      • et al.
      Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.
      Two of the nine studies met three criteria,
      • Snoek J.A.
      • Prescott E.I.
      • van der Velde A.E.
      • et al.
      Effectiveness of home-based mobile guided cardiac rehabilitation as alternative strategy for333 nonparticipation in clinic-based cardiac rehabilitation among elderly patients in Europe: a randomized clinical trial.
      ,
      • Piotrowicz E.
      • Pencina M.J.
      • Opolski G.
      • et al.
      Effects of a 9-week hybrid comprehensive telerehabilitation program on long-term outcomes in patients with heart failure: the telerehabilitation in heart failure patients (TELEREH-HF) randomized clinical trial.
      and four studies met two of the four essential methodological elements.
      • Batalik L.
      • Dosbaba F.
      • Hartman M.
      • Batalikova K.
      • Spinar J.
      Benefits and effectiveness of using a wrist heart rate monitor as a telerehabilitation device in cardiac patients: A randomized controlled trial.
      ,
      • Bravo-Escobar R.
      • González-Represas A.
      • Gómez-González A.M.
      • et al.
      Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: a randomised, controlled clinical trial.
      ,
      • Piotrowicz E.
      • Baranowski R.
      • Bilinska M.
      • et al.
      A new model of home-based telemonitored cardiac rehabilitation in patients with heart failure: effectiveness, quality of life, and adherence.
      ,
      • Corvera-Tindel T.
      • Doering L.V.
      • Woo M.A.
      • Khan S.
      • Dracup K.
      Effects of a home walking exercise program on functional status and symptoms in heart failure.
      All studies used randomization for group allocation. However, two studies did not provide a specific description of the randomization process or insufficient description.
      • Piotrowicz E.
      • Baranowski R.
      • Bilinska M.
      • et al.
      A new model of home-based telemonitored cardiac rehabilitation in patients with heart failure: effectiveness, quality of life, and adherence.
      ,
      • Corvera-Tindel T.
      • Doering L.V.
      • Woo M.A.
      • Khan S.
      • Dracup K.
      Effects of a home walking exercise program on functional status and symptoms in heart failure.
      The randomization procedure was stratified well in five studies.
      • Snoek J.A.
      • Prescott E.I.
      • van der Velde A.E.
      • et al.
      Effectiveness of home-based mobile guided cardiac rehabilitation as alternative strategy for333 nonparticipation in clinic-based cardiac rehabilitation among elderly patients in Europe: a randomized clinical trial.
      • Piotrowicz E.
      • Pencina M.J.
      • Opolski G.
      • et al.
      Effects of a 9-week hybrid comprehensive telerehabilitation program on long-term outcomes in patients with heart failure: the telerehabilitation in heart failure patients (TELEREH-HF) randomized clinical trial.
      ,
      • Bravo-Escobar R.
      • González-Represas A.
      • Gómez-González A.M.
      • et al.
      Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: a randomised, controlled clinical trial.
      ,
      • Sibilitz K.L.
      • Berg S.K.
      • Rasmussen T.B.
      • et al.
      Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.
      Stratification using a computer algorithm,
      • Snoek J.A.
      • Prescott E.I.
      • van der Velde A.E.
      • et al.
      Effectiveness of home-based mobile guided cardiac rehabilitation as alternative strategy for333 nonparticipation in clinic-based cardiac rehabilitation among elderly patients in Europe: a randomized clinical trial.
      ,
      • Piotrowicz E.
      • Pencina M.J.
      • Opolski G.
      • et al.
      Effects of a 9-week hybrid comprehensive telerehabilitation program on long-term outcomes in patients with heart failure: the telerehabilitation in heart failure patients (TELEREH-HF) randomized clinical trial.
      ,
      • Bravo-Escobar R.
      • González-Represas A.
      • Gómez-González A.M.
      • et al.
      Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: a randomised, controlled clinical trial.
      according to age and sex,
      • Taylor J.L.
      • Holland D.J.
      • Keating S.E.
      • et al.
      Short-term and long-term feasibility, safety, and efficacy of high-intensity interval training in cardiac rehabilitation: the FITR heart study randomized clinical trial.
      or according to the left ventricle ejection fraction classification and type of treatment
      • Sibilitz K.L.
      • Berg S.K.
      • Rasmussen T.B.
      • et al.
      Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.
      was used to balance the experimental and control groups. The remaining two studies performed a simple randomization procedure without stratification.
      • Batalik L.
      • Dosbaba F.
      • Hartman M.
      • Batalikova K.
      • Spinar J.
      Benefits and effectiveness of using a wrist heart rate monitor as a telerehabilitation device in cardiac patients: A randomized controlled trial.
      ,
      • Hwang R.
      • Bruning J.
      • Morris N.R.
      • Mandrusiak A.
      • Russell T.
      Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial.
      A total of eight of all studies reported an unbiased randomization process using automated randomization procedure
      • Snoek J.A.
      • Prescott E.I.
      • van der Velde A.E.
      • et al.
      Effectiveness of home-based mobile guided cardiac rehabilitation as alternative strategy for333 nonparticipation in clinic-based cardiac rehabilitation among elderly patients in Europe: a randomized clinical trial.
      ,
      • Piotrowicz E.
      • Pencina M.J.
      • Opolski G.
      • et al.
      Effects of a 9-week hybrid comprehensive telerehabilitation program on long-term outcomes in patients with heart failure: the telerehabilitation in heart failure patients (TELEREH-HF) randomized clinical trial.
      ,
      • Batalik L.
      • Dosbaba F.
      • Hartman M.
      • Batalikova K.
      • Spinar J.
      Benefits and effectiveness of using a wrist heart rate monitor as a telerehabilitation device in cardiac patients: A randomized controlled trial.
      ,
      • Bravo-Escobar R.
      • González-Represas A.
      • Gómez-González A.M.
      • et al.
      Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: a randomised, controlled clinical trial.
      • Sibilitz K.L.
      • Berg S.K.
      • Rasmussen T.B.
      • et al.
      Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.
      • Piotrowicz E.
      • Baranowski R.
      • Bilinska M.
      • et al.
      A new model of home-based telemonitored cardiac rehabilitation in patients with heart failure: effectiveness, quality of life, and adherence.
      or using sealed envelopes obtained from the research assistant before the first data collection.
      • Taylor J.L.
      • Holland D.J.
      • Keating S.E.
      • et al.
      Short-term and long-term feasibility, safety, and efficacy of high-intensity interval training in cardiac rehabilitation: the FITR heart study randomized clinical trial.
      ,
      • Hwang R.
      • Bruning J.
      • Morris N.R.
      • Mandrusiak A.
      • Russell T.
      Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial.
      Evaluator blinding for at least one of the primary outcomes was performed in a total of six studies.
      • Snoek J.A.
      • Prescott E.I.
      • van der Velde A.E.
      • et al.
      Effectiveness of home-based mobile guided cardiac rehabilitation as alternative strategy for333 nonparticipation in clinic-based cardiac rehabilitation among elderly patients in Europe: a randomized clinical trial.
      • Piotrowicz E.
      • Pencina M.J.
      • Opolski G.
      • et al.
      Effects of a 9-week hybrid comprehensive telerehabilitation program on long-term outcomes in patients with heart failure: the telerehabilitation in heart failure patients (TELEREH-HF) randomized clinical trial.
      ,
      • Hwang R.
      • Bruning J.
      • Morris N.R.
      • Mandrusiak A.
      • Russell T.
      Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial.
      ,
      • Sibilitz K.L.
      • Berg S.K.
      • Rasmussen T.B.
      • et al.
      Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.
      ,
      • Piotrowicz E.
      • Baranowski R.
      • Bilinska M.
      • et al.
      A new model of home-based telemonitored cardiac rehabilitation in patients with heart failure: effectiveness, quality of life, and adherence.
      In five studies, intention-to-treat analysis was performed on outcomes of interest.
      • Snoek J.A.
      • Prescott E.I.
      • van der Velde A.E.
      • et al.
      Effectiveness of home-based mobile guided cardiac rehabilitation as alternative strategy for333 nonparticipation in clinic-based cardiac rehabilitation among elderly patients in Europe: a randomized clinical trial.
      ,
      • Taylor J.L.
      • Holland D.J.
      • Keating S.E.
      • et al.
      Short-term and long-term feasibility, safety, and efficacy of high-intensity interval training in cardiac rehabilitation: the FITR heart study randomized clinical trial.
      ,
      • Hwang R.
      • Bruning J.
      • Morris N.R.
      • Mandrusiak A.
      • Russell T.
      Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial.
      ,
      • Sibilitz K.L.
      • Berg S.K.
      • Rasmussen T.B.
      • et al.
      Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.
      ,
      • Corvera-Tindel T.
      • Doering L.V.
      • Woo M.A.
      • Khan S.
      • Dracup K.
      Effects of a home walking exercise program on functional status and symptoms in heart failure.
      Information on the study flow was provided for all studies, including those that described patient withdrawals or dropouts.
      Three studies out of nine were reported as high quality in both qualitative evaluation scales.
      • Taylor J.L.
      • Holland D.J.
      • Keating S.E.
      • et al.
      Short-term and long-term feasibility, safety, and efficacy of high-intensity interval training in cardiac rehabilitation: the FITR heart study randomized clinical trial.
      ,
      • Hwang R.
      • Bruning J.
      • Morris N.R.
      • Mandrusiak A.
      • Russell T.
      Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial.
      ,
      • Sibilitz K.L.
      • Berg S.K.
      • Rasmussen T.B.
      • et al.
      Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.
      None of the included studies showed low-quality ratings. These results represent a low risk of bias and solid evidence.

      Incidence of adverse events

      Table 1 shows AEs reported in included HBCR studies. Five of the nine included studies showed AEs incidence,
      • Snoek J.A.
      • Prescott E.I.
      • van der Velde A.E.
      • et al.
      Effectiveness of home-based mobile guided cardiac rehabilitation as alternative strategy for333 nonparticipation in clinic-based cardiac rehabilitation among elderly patients in Europe: a randomized clinical trial.
      ,
      • Taylor J.L.
      • Holland D.J.
      • Keating S.E.
      • et al.
      Short-term and long-term feasibility, safety, and efficacy of high-intensity interval training in cardiac rehabilitation: the FITR heart study randomized clinical trial.
      ,
      • Hwang R.
      • Bruning J.
      • Morris N.R.
      • Mandrusiak A.
      • Russell T.
      Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial.
      • Sibilitz K.L.
      • Berg S.K.
      • Rasmussen T.B.
      • et al.
      Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.
      of which only one study
      • Taylor J.L.
      • Holland D.J.
      • Keating S.E.
      • et al.
      Short-term and long-term feasibility, safety, and efficacy of high-intensity interval training in cardiac rehabilitation: the FITR heart study randomized clinical trial.
      reported (n = 1) severe AEs associated with HBCR exercise, and the remaining identified AEs was not associated with exercise; the remaining four studies reported exercise intervention without AEs. The incidence rate of severe AEs was estimated as 1 per 23,823 patient-hour of HBCR exercise. There were no exercise-related deaths. The distribution of patients by cardiovascular risk stratification is shown in Fig. 2.
      Table 1Adverse or cardiac events reported in studies.
      Author (year)ParticipantsAdverse/cardiac events
      Smartet al.(2021)
      • Snoek J.A.
      • Prescott E.I.
      • van der Velde A.E.
      • et al.
      Effectiveness of home-based mobile guided cardiac rehabilitation as alternative strategy for333 nonparticipation in clinic-based cardiac rehabilitation among elderly patients in Europe: a randomized clinical trial.
      n = 179mCR group: 12 serious AEs

      CG: 10 serious AEs

      Serious AEs were not more frequent in the mCR group than in the control group. n = 12/89 in the mCR group (13%) compared to n = 10/90 in the control group (11%). The majority of patients were admitted to hospital for acute (6/19 [3%]) or chronic (8/19[42 percent]) coronary syndrome.
      Snoek et al. (2021)
      • Taylor J.L.
      • Holland D.J.
      • Keating S.E.
      • et al.
      Short-term and long-term feasibility, safety, and efficacy of high-intensity interval training in cardiac rehabilitation: the FITR heart study randomized clinical trial.
      n = 939 AEs (6 in HIIT group and 3 in MICT group)

      None of these were determined to be the consequence of exercise training by the treating physician.
      Taylor et al. (2020)
      • Piotrowicz E.
      • Pencina M.J.
      • Opolski G.
      • et al.
      Effects of a 9-week hybrid comprehensive telerehabilitation program on long-term outcomes in patients with heart failure: the telerehabilitation in heart failure patients (TELEREH-HF) randomized clinical trial.
      n = 850No AEs or deaths occurred during exercise training sessions
      Piotrowicz et al. (2020)
      • Batalik L.
      • Dosbaba F.
      • Hartman M.
      • Batalikova K.
      • Spinar J.
      Benefits and effectiveness of using a wrist heart rate monitor as a telerehabilitation device in cardiac patients: A randomized controlled trial.
      n = 561 reported chest pain symptom during cardiopulmonary exercise test (CPET)

      None acute cardiac-related event, no serious complications related to physical training reported.
      Batalik et al. (2020)
      • Hwang R.
      • Bruning J.
      • Morris N.R.
      • Mandrusiak A.
      • Russell T.
      Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial.
      n = 53IG: 6 AEs (3 angina, 1 diaphoresis, 2 palipations)

      CG: 2 AEs (2 diaphoresis)

      No deaths, cardiac arrest, syncope symptoms or fall in either group during exercise session reported.
      Hwanget al. (2017)
      • Bravo-Escobar R.
      • González-Represas A.
      • Gómez-González A.M.
      • et al.
      Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: a randomised, controlled clinical trial.
      n = 28IG (mixed surveillance program): during HBCR no cardiac complication or AEs reported/ 1 patient had hypertensive response due to exercise, 1 patient had hypotensive response (these 2 incidents occurred during training sessions at hospital)

      CG (usual CBCR): 2 patients reported angina type pain without electrical changes [telemonitoring], 1 patient reported arrythmias, 2 patients hypertensive response subsided with rest, 1 patient hypotensive response required administration of intravenous saline solution.
      Bravo-Escobar et al. (2017)
      • Sibilitz K.L.
      • Berg S.K.
      • Rasmussen T.B.
      • et al.
      Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.
      n = 147IG: 2 serious adverse events

      CG: 1 serious event

      Adverse events were not caused by intervention (post-surgical tamponade and 1 HF related readmission.

      11/72 (15.3%) self-reported non serious adverse events (primarily caused by musculoskeletal problem related to exercise training)
      Sibilitz et al. (2016)
      • Piotrowicz E.
      • Baranowski R.
      • Bilinska M.
      • et al.
      A new model of home-based telemonitored cardiac rehabilitation in patients with heart failure: effectiveness, quality of life, and adherence.
      n = 152No AEs reported, no deaths or hospitalization
      Piotrowicz et al. (2010)
      • Corvera-Tindel T.
      • Doering L.V.
      • Woo M.A.
      • Khan S.
      • Dracup K.
      Effects of a home walking exercise program on functional status and symptoms in heart failure.
      n = 78No severe AEs during or immediately following exercise
      mCR: Mobile cardiac rehabilitation; HIIT: High Intensity Interval Training; MICT: Moderate Intensity Continuous Training; IG: Intervention group; CG: Control group; CBCR: Centre-based cardiac rehabilitation.
      Fig. 2
      Fig. 2Distribution of patients according to risk of cardiovascular complications.
      Of the nine included studies, three studies
      • Snoek J.A.
      • Prescott E.I.
      • van der Velde A.E.
      • et al.
      Effectiveness of home-based mobile guided cardiac rehabilitation as alternative strategy for333 nonparticipation in clinic-based cardiac rehabilitation among elderly patients in Europe: a randomized clinical trial.
      ,
      • Batalik L.
      • Dosbaba F.
      • Hartman M.
      • Batalikova K.
      • Spinar J.
      Benefits and effectiveness of using a wrist heart rate monitor as a telerehabilitation device in cardiac patients: A randomized controlled trial.
      ,
      • Bravo-Escobar R.
      • González-Represas A.
      • Gómez-González A.M.
      • et al.
      Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: a randomised, controlled clinical trial.
      included patients at low to intermediate cardiovascular risk, two studies
      • Taylor J.L.
      • Holland D.J.
      • Keating S.E.
      • et al.
      Short-term and long-term feasibility, safety, and efficacy of high-intensity interval training in cardiac rehabilitation: the FITR heart study randomized clinical trial.
      ,
      • Sibilitz K.L.
      • Berg S.K.
      • Rasmussen T.B.
      • et al.
      Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.
      included a combination of patients with all risk levels, and four studies included high-risk patients.
      • Piotrowicz E.
      • Pencina M.J.
      • Opolski G.
      • et al.
      Effects of a 9-week hybrid comprehensive telerehabilitation program on long-term outcomes in patients with heart failure: the telerehabilitation in heart failure patients (TELEREH-HF) randomized clinical trial.
      ,
      • Hwang R.
      • Bruning J.
      • Morris N.R.
      • Mandrusiak A.
      • Russell T.
      Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial.
      ,
      • Piotrowicz E.
      • Baranowski R.
      • Bilinska M.
      • et al.
      A new model of home-based telemonitored cardiac rehabilitation in patients with heart failure: effectiveness, quality of life, and adherence.
      ,
      • Corvera-Tindel T.
      • Doering L.V.
      • Woo M.A.
      • Khan S.
      • Dracup K.
      Effects of a home walking exercise program on functional status and symptoms in heart failure.

      Discussion

      Rapidly evolving technological progress could improve communication between patients and CR providers. Further, it can increase the effectiveness of patient safety monitoring, extending the reach of providers beyond traditional CBCR services and more into the home-based setting. This review incorporates the most recent findings from relevant literature on HBCR safety. Nine studies synthesized this systematic review providing an overview of HBCR safety. The selected experimental sample consisted of (n = 808) patients with various CVDs. Of the included studies, only Snoek et al. reported severe exercise-related AEs
      • Taylor J.L.
      • Holland D.J.
      • Keating S.E.
      • et al.
      Short-term and long-term feasibility, safety, and efficacy of high-intensity interval training in cardiac rehabilitation: the FITR heart study randomized clinical trial.
      requiring an emergency call because of post-exercise hypotension. The significant finding is that HBCR seems to be a safe alternative, with the incidence of 1 severe AEs event per 23,823 patient-hours of HBCR exercise; no exercise-related deaths or hospitalizations were recorded.
      There has been little published evidence on the safety of the HBCR so far. A recent review reported an indication among (n = 545) patients that there was no cause of mortality or significant complications associated with cardiac telerehabilitation interventions.
      • Batalik L.
      • Filakova K.
      • Batalikova K.
      • Dosbaba F.
      Remotely monitored telerehabilitation for cardiac patients: a review of the current situation.
      The Cochrane analysis of HBCR reported a similar incidence of AEs between HBCR and CBCR.
      • Anderson L.
      • Sharp G.A.
      • Norton R.J.
      • et al.
      Home-based versus centre-based cardiac rehabilitation.
      Comparing our results of AEs incidence with CBCR, there are three detailed safety studies.
      • Pavy B.
      • Iliou M.C.
      • Meurin P.
      • Tabet J.Y.
      • Corone S.
      Functional evaluation and cardiac rehabilitation working group of the french society of cardiology. Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation.
      • Saito M.
      • Ueshima K.
      • Saito M.
      • et al.
      Safety of exercise-based cardiac rehabilitation and exercise testing for cardiac patients in Japan: a nationwide survey.
      • Scheinowitz M.
      • Harpaz D.
      Safety of cardiac rehabilitation in a medically supervised, community-based program.
      During 42,419 stress tests and 743,471 patient-hour training, 20 severe AEs occurred in 17 patients. The rate of cardiac arrest was 1.3 per million patient-hour exercises; the rate of events was 1 per 49,565 patient-hour exercises. There were no fatal complications or emergency defibrillations.
      • Pavy B.
      • Iliou M.C.
      • Meurin P.
      • Tabet J.Y.
      • Corone S.
      Functional evaluation and cardiac rehabilitation working group of the french society of cardiology. Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation.
      All AEs and life-threatening AEs rates during exercise were 12 and 1 event/383 096 patient-hours, respectively.
      • Saito M.
      • Ueshima K.
      • Saito M.
      • et al.
      Safety of exercise-based cardiac rehabilitation and exercise testing for cardiac patients in Japan: a nationwide survey.
      According to Saito et al., special care should be taken during the first sessions of the CR program.
      • Scheinowitz M.
      • Harpaz D.
      Safety of cardiac rehabilitation in a medically supervised, community-based program.
      This evidence shows that exercise-based CBCR is generally safe and followed by a very low incidence of cardiovascular events. A notably lower incidence of exercise-related AEs was observed in patients who were individually assessed with baseline cardiopulmonary exercise testing and given an individual exercise prescription. This combination of baseline assessments appears to be a necessary safety standard for HBCR programs to reduce the risk of AEs.
      Finally, comparing our HBCR results with CBCR, it is clear that the incidence of AEs is low in both CR models. Indeed, it should be mentioned that of the sample of included studies, four studies reported no severe AEs. Five studies reported severe AEs. However, these AEs were not associated with exercise after detailed examination, as the authors and researchers explained. These were most typically hyper/hypotensive post-exercise reactions that resolved during the restitution. Hypotensive or hypertensive reactions after exercise are usually common in supervised CBCR.
      • Quindry J.C.
      • McNamara M.
      • Oser C.
      • Fogle C.
      Cardiac rehabilitation and resting blood pressure: montana outcomes project cardiac rehabilitation registry findings.
      ,
      • Low D.A.
      • da Nóbrega A.C.
      • Mathias CJ.
      Exercise-induced hypotension in autonomic disorders.
      Therefore, it can be assumed that in the HBCR model, mild AEs can be partially prevented by comprehensive baseline education and ongoing telemonitoring.
      • Saito M.
      • Ueshima K.
      • Saito M.
      • et al.
      Safety of exercise-based cardiac rehabilitation and exercise testing for cardiac patients in Japan: a nationwide survey.
      ,
      • Hu Y.
      • Li L.
      • Wang T.
      • et al.
      Comparison of cardiac rehabilitation (exercise + education), exercise only, and usual care for patients with coronary artery disease: a non-randomized retrospective analysis.
      Another point that should be discussed is the exercise-related cardiovascular risk stratification of the patients. Recently, an assumption has favored including patients with low to moderate cardiovascular risk in HBCR. High-risk patients were usually advised to exercise under direct supervision.
      • Thomas R.J.
      • Beatty A.L.
      • Beckie T.M.
      • et al.
      Home-based cardiac rehabilitation: a scientific statement from the American Association of Cardiovascular and Pulmonary Rehabilitation, The American Heart Association, and the American College of Cardiology.
      ,
      • Pollock H.
      • Garnett A.
      Effectiveness of home-based cardiac rehabilitation and its importance during COVID-19.
      ,
      • Dalal H.M.
      • Doherty P.
      • McDonagh S.T.
      • et al.
      Virtual and in-person cardiac rehabilitation.
      In our review, six studies included high-risk patients.
      • Taylor J.L.
      • Holland D.J.
      • Keating S.E.
      • et al.
      Short-term and long-term feasibility, safety, and efficacy of high-intensity interval training in cardiac rehabilitation: the FITR heart study randomized clinical trial.
      ,
      • Piotrowicz E.
      • Pencina M.J.
      • Opolski G.
      • et al.
      Effects of a 9-week hybrid comprehensive telerehabilitation program on long-term outcomes in patients with heart failure: the telerehabilitation in heart failure patients (TELEREH-HF) randomized clinical trial.
      ,
      • Hwang R.
      • Bruning J.
      • Morris N.R.
      • Mandrusiak A.
      • Russell T.
      Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial.
      ,
      • Piotrowicz E.
      • Baranowski R.
      • Bilinska M.
      • et al.
      A new model of home-based telemonitored cardiac rehabilitation in patients with heart failure: effectiveness, quality of life, and adherence.
      ,
      • Corvera-Tindel T.
      • Doering L.V.
      • Woo M.A.
      • Khan S.
      • Dracup K.
      Effects of a home walking exercise program on functional status and symptoms in heart failure.
      Thus, there is no longer reason to question the inclusion of high-risk patients in HBCR. On the other hand, most studies that included high-risk patients in HBCR performed real-time telemonitoring. This approach implies higher safety measures and costs than post-exercise telemonitoring.
      The quality assessment of the included studies showed the high quality of design and reporting, representing a solid body of evidence-based medicine. No low-quality results of included studies were noted. This quality assessment shows that the sample of studies is robust and the results can be well reproduced. Compared with the last review in 2015, the quality of HBCR studies has increased significantly.
      • Frederix I.
      • Vanhees L.
      • Dendale P.
      • Goetschalckx K.
      A review of telerehabilitation for cardiac patients.

      Strength and limitations

      Safety research is critical at this time, when patients with CVDs are more likely to be older and frail, have more comorbidities, and/or have higher cardiovascular risk. Indeed, assumptions about the clinical safety and efficacy of HBCR in these patients should be more carefully evaluated.
      A key component of this review is that it is the first systematic review to examine the safety of HBCR, which may provide new insights and support for this alternative model. The second strength of the study is that we focused only on high-quality RCTs for analysis. In addition, another strength of this review is that the included RCTs examined the safety of the intervention as a primary or secondary outcome, and the individual AEs were reported in detail.
      However, authors must acknowledge several limitations. First, there was heterogeneity in intervention methods (i.e., type, duration, frequency, intensity). Most studies included a mixed population and used different interventions, physical fitness methods, and monitoring periods. In particular, the patient monitoring methodologies reported in the studies varied, from real-time monitoring to patient-reported post-exercise telemonitoring, which may partly bias the overall view on HBCR safety.
      In addition, there were only nine high-quality RCTs that provided research evidence on the safety of HBCR. Moreover, only three studies include participant samples more significant than 150. Therefore, this result may provide only a limited insight into the safety of HBCR interventions. Future HBCR studies should include adequately robust samples, emphasizing detailed follow-up of AEs’ incidence.

      Implications for clinical practice

      In patients with CVD (acute myocardial infarction, cardiac revascularization, or heart failure), HBCR and CBCR appear to be equally safe models for improving clinical and health-related quality of life outcomes. Recently, there has been a high-priority call to increase patient participation in CR.
      • Ades P.A.
      • Keteyian S.J.
      • Wright J.S.
      • et al.
      Increasing cardiac rehabilitation participation from 20% to 70%: a road map from the million hearts cardiac rehabilitation collaborative.
      ,
      • Scherrenberg M.
      • Wilhelm M.
      • Hansen D.
      • et al.
      The future is now: a call for action for cardiac telerehabilitation in the COVID-19 pandemic from the secondary prevention and rehabilitation section of the European Association of Preventive Cardiology.
      Therefore, to fill the gap, HBCR could be a suitable alternative for the whole population of CVD patients who cannot attend CBCR. Moreover, by optimizing the form of supervision in HBCR, all CVDs groups of patients can be enrolled, from post-exercise monitoring of patients at low to intermediate risk to real-time monitoring of patients at high risk of exercise-related cardiovascular complications.

      Future perspectives

      The safety of HBCR needs to be established for broader eligible subgroups of patients (i.e., older adults; patients with multiple diseases; obese individuals; frail patients or socioeconomically impaired; ethnic minorities; rural residents) for whom HBCR may not achieve comparable levels of safety. In order to tailor HBCR to different patient needs, baseline knowledge about CR frequency, format, teaching, training intensity, and behavior change strategies should be clarified for patients.
      • Batalik L.
      • Pepera G.
      • Papathanasiou J.
      • et al.
      Is the training intensity in phase two cardiovascular rehabilitation different in telehealth versus outpatient rehabilitation?.
      • Keteyian S.J.
      • Grimshaw C.
      • Brawner C.A.
      • et al.
      A comparison of exercise intensity in hybrid versus standard phase two cardiac rehabilitation.
      • Rohrbach G.
      • Schopfer D.W.
      • Krishnamurthi N.
      • et al.
      The design and implementation of a home-based cardiac rehabilitation program.
      • Poortaghi S.
      • Baghernia A.
      • Golzari S.E.
      • Safayian A.
      • Atri S.B.
      The effect of home-based cardiac rehabilitation program on self efficacy of patients referred to cardiac rehabilitation center.
      In addition, more research is needed to identify how HBCR affects safety in the long term (beyond 12 months), including research on HBCR safety in middle- and low-income countries.
      More extensive studies are needed to determine the safety and efficacy of high-intensity interval training in the home setting for different subgroups of patients with CVD, including high-risk populations.
      CBCR has well-defined guidelines and standards of care that include core components, clinical practice guidelines, and performance assessments.
      • Balady G.J.
      • Williams M.A.
      • Ades P.A.
      • et al.
      Core components of cardiac rehabilitation/secondary prevention programs: 2007 update: a scientific statement from the American Heart Association Exercise, Cardiac rehabilitation, and Prevention Committee, The Council on Clinical Cardiology; The Councils on Cardiovascular Nursing, Epidemiology and Prevention, and Nutrition, Physical activity, and Metabolism; and The American Association of Cardiovascular and Pulmonary Rehabilitation.
      • Hamm L.F.
      • Sanderson B.K.
      • Ades P.A.
      • et al.
      Core competencies for cardiac rehabilitation/secondary prevention professionals: 2010 update.
      • Leon A.S.
      • Franklin B.A.
      • Costa F.
      • et al.
      Cardiac rehabilitation and secondary prevention of coronary heart disease: an American Heart Association scientific statement from the council on clinical cardiology (subcommittee on exercise, cardiac rehabilitation, and prevention) and the council on nutrition, physical activity, and metabolism (subcommittee on physical activity), in collaboration with the American association of cardiovascular and pulmonary rehabilitation.
      • Thomas R.J.
      • King M.
      • Lui K.
      • Oldridge N.
      • Piña I.L.
      • Spertus J.
      AACVPR/ACCF/AHA 2010 update: performance measures on cardiac rehabilitation for referral to cardiac rehabilitation/secondary prevention services: a report of the American association of cardiovascular and pulmonary rehabilitation and the American College of Cardiology Foundation/American Heart Association Task Force on performance measures (writing committee to develop clinical performance measures for cardiac rehabilitation).
      • Thomas R.J.
      • Balady G.
      • Banka G.
      • et al.
      ACC/AHA clinical performance and quality measures for cardiac rehabilitation: a report of the American College of Cardiology/American Heart Association Task Force on performance measures.
      However, there are currently no specific guidelines or standards for HBCR. Standards of practice are necessary to establish proper therapy parameters. Evidence-based treatment alternatives should be tailored to patient needs and preferences. In the absence of such guidance, there is a risk that the quality and effect of HBCR interventions could vary.
      Furthermore, given the COVID-19 pandemic, alternative HBCR approaches are frequent.
      • Keteyian S.J.
      • Ades P.A.
      • Beatty A.L.
      • et al.
      A review of the design and implementation of a hybrid cardiac rehabilitation program: an expanding opportunity for optimizing cardiovascular care.
      ,
      • Epstein E.
      • Patel N.
      • Maysent K.
      • Taub P.R.
      Cardiac rehab in the COVID era and beyond: mHealth and other novel opportunities.
      Future research is needed to assess safety in hybrid models of CR that include components from both CBCR and HBCR. These significant results can be used in policy decisions for reimbursement from insurance companies or third parties, a critical step for the potential implementation of HBCR services.
      Finally, artificial intelligence, which has a high level of data mining and interpretation, may provide significant future potential for HBCR. Tailored HBCR can be realized by leveraging artificial intelligence through wearable monitoring and coaching. Via algorithms and artificial intelligence models, wearable devices could accurately identify physical activity and exercise to evaluate patient safety during HBCR. Moreover, combined with telehealth coaching, artificial intelligence could analyze telemonitored data in real-time, allowing platforms to deliver timely coaching and more targeted guidance.
      • Su J.
      • Zhang Y.
      • Ke Q.Q.
      • Su J.K.
      • Yang Q.H.
      Mobilizing artificial intelligence to cardiac telerehabilitation.

      Conclusion

      According to this systematic review, HBCR could provide a safe and usable alternative form of CR. The incidence of AEs in selected HBCR studies was low. Research has shown that the HBCR model may represent an equivalent intervention model for stable patients with CVD at all levels of risk for exercise-related cardiovascular complications who are unable or do not have access to CBCR services.

      Funding

      This work was supported by the Ministry of Health, Czech Republic - conceptual development of research organization (FNBr, 65269705)

      Declaration of competing interest

      The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
      Batalik Ladislav reports administrative support and article publishing charges were provided by University Hospital Brno.

      Appendices

      Table A.1Search MeSH terms and keywords.
      Remote rehabilitationCardiac rehabilitation/ Cardiovascular rehabilitation/ Cardiopulmonary rehabilitation
      Mobile healthHome based rehabilitation
      eHealthOutpatient cardiac rehabilitation
      mHealthExercise-based training/ (Physical activity, Physical training)-based rehabilitation
      TelehealthMultidisciplinary rehabilitation/ Hybrid rehabilitation
      TelemedicineSafety/ Safety control/ Intervention safety/ Safety concerns
      TelerehabilitationAdverse events/ Cardiac events/ Cardiovascular complications/ Cardiac complications/Rehospitalization/ Hospital readmission/
      Virtual rehabilitationCardiac patients/ HF patients/ CVD patients/ Coronary artery patients/ Heart patients/ Aortic patients/ Atrial fibrillation patients
      Internet based rehabilitation
      Table B.1Studies characteristics.
      Author (year)MethodParticipantsPopulationInterventionOutcomes
      Smart et al. (2015)
      • Smart N.A.
      • Waldron M.
      • Ismail H.
      • et al.
      Validation of a new tool for the assessment of study quality and reporting in exercise training studies: TESTEX.
      RCTn = 179, (81% males)

      [median age 72 range, 65-87 years]
      Αcute Coronary Syndrome, Coronary revascularization, Surgical or percutaneous treatment for Valvular disease,

      documented CAD
      IG:6-months HBCR

      CG: Usual care
      (a) Peak oxygen uptake (after 6 months)

      (b) Habitual PA

      (c) CVRF

      (d) Incidence of AEs
      Snoek et al. (2021)
      • Snoek J.A.
      • Prescott E.I.
      • van der Velde A.E.
      • et al.
      Effectiveness of home-based mobile guided cardiac rehabilitation as alternative strategy for333 nonparticipation in clinic-based cardiac rehabilitation among elderly patients in Europe: a randomized clinical trial.
      Single-center RCTn = 93 8 (84% males)

      [mean age 65 ± 8 years]
      Patients with CAD4 weeks supervised CBCR training with subsequent HB training(a) Changes in VO2 peak

      (b) Cardiorespiratory fitness

      (c) feasibility

      (d) safety

      (e) adherence

      (f) CVRF

      (g) QoL
      Taylor et al. (2020)
      • Taylor J.L.
      • Holland D.J.
      • Keating S.E.
      • et al.
      Short-term and long-term feasibility, safety, and efficacy of high-intensity interval training in cardiac rehabilitation: the FITR heart study randomized clinical trial.
      Multicenter prospective RCTN = 850 HCTR group (88.7% males)

      [mean age, 62.6 ±10.8 years)

      Usual care group (88.5% males)

      [mean age, 62.2± 10.2 years]
      Heart Failure patientsIG: 9 weeks ΗCTR program (1 week in hospital and 8 weeks at home)

      CG: usual care
      (a) Maintenance of benefits (14-26 months)

      (b) Safety of HCTR (at 9 weeks)

      (c) Tertiary outcomes (after 9 weeks)

      i. Distance in 6MWDT

      ii. CPET time

      iii. Peak oxygen consumption

      iv. RER

      v. QoL (Form-36 score)


      Piotrowicz et al. (2020)
      • Piotrowicz E.
      • Pencina M.J.
      • Opolski G.
      • et al.
      Effects of a 9-week hybrid comprehensive telerehabilitation program on long-term outcomes in patients with heart failure: the telerehabilitation in heart failure patients (TELEREH-HF) randomized clinical trial.


      RCT


      N = 56 (82.5% males)

      (mean age 57.7 ± 7.6)


      Cardiac patients (heart revascularization [percutaneous angioplasty and aortocoronary bypass])
      IG1: 12-week ROT

      IG2:12-week ITG
      (a) Physical fitness

      (b) QoL

      (c) Training adherence

      (d) Cardiac events and hospitalizations
      Batalik et al. (2020)
      • Batalik L.
      • Dosbaba F.
      • Hartman M.
      • Batalikova K.
      • Spinar J.
      Benefits and effectiveness of using a wrist heart rate monitor as a telerehabilitation device in cardiac patients: A randomized controlled trial.
      RCTN = 53 (75% males)

      [mean age 67 years]
      Patients with stable chronic heart failure (including heart failure with reduced or preserved ejection fractionIG: 12-week, HB exercise & education.

      CG: 12-week, hospital outpatient-based program.
      (a) Changes in 6MWT

      (b) functional measures

      (c) QoL

      (d) patient satisfaction

      (e) attendance rates

      (f) AEs
      Hwang et al. (2017)
      • Hwang R.
      • Bruning J.
      • Morris N.R.
      • Mandrusiak A.
      • Russell T.
      Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial.


      RCT
      N = 28 (100% males)

      [mean age 56.07±8.92 years]
      Patients with stable CAD at moderate cardiovascular riskIG: HB mixed surveillance program

      CG: CBCR
      (a) Exercise capacity

      (b) risk profile

      (c) QoL

      (d) effectiveness

      (e) safety
      Bravo-Escobar et al. (2017)
      • Bravo-Escobar R.
      • González-Represas A.
      • Gómez-González A.M.
      • et al.
      Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: a randomised, controlled clinical trial.
      RCTN = 147 (76% males)

      [mean age 62 years]
      Patients after heart valve surgery aortic (62%), mitral (36%) or tricuspid/pulmonary valve surgery (2%)IG:12 week-CR HB (31%) or CB (69%)

      CG: usual care
      (a) Physical capacity (VO2 peak)

      (b) mental health

      (c) safety considerations
      Sibilitz et al. (2016)
      • Sibilitz K.L.
      • Berg S.K.
      • Rasmussen T.B.
      • et al.
      Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.
      RCTn = 152 (90% males)

      [mean age 58.1 ± 10.2 years]
      Heart Failure patients (NYHA class II and III, ejection fraction <40%)IG: 8-week HTCR program

      CG: Outpatient-based standard CR
      (a) Effectiveness:

      i. NYHA class

      ii. Peak oxygen consumption

      iii. 6MWDT

      iv. SF-36 score

      (b) Safety of CR and HBCR
      Piotrowicz et al. (2010)
      • Piotrowicz E.
      • Baranowski R.
      • Bilinska M.
      • et al.
      A new model of home-based telemonitored cardiac rehabilitation in patients with heart failure: effectiveness, quality of life, and adherence.
      RCTn = 78 (99% males)

      [mean age 62.6 ±10.6 years]
      HF patients’ ejection fraction 27% ± 8.8%; 63 [80%] New York Heart Association class II; 15[20%] New York Heart Association class III–IV)IG: Home walking exercise CG: usual activities(a) Event rates,

      (b) Compliance to training

      (c) Functional status

      (d) Symptoms
      IG: Intervention group; CG: Control group; PA: Physical activity; AEs: Adverse events; CVRF: Cardiovascular risk factors; CAD: Coronary artery disease; HCTR: Hybrid comprehensive telerehabilitation; 6MWDT: 6 min walk distance test; CPET: Cardiopulmonary exercise test; IG1/IG2: Interventional group 1/ Interventional group 2; ROT: Regular outpatient training; ITG: Interventional telerehabilitation group; HB: Home-based; CB: Center-based; QoL: Quality of life.
      Table C.1Results of the study quality and reporting.
      StudyStudy quality (max. 5)Study reporting (max. 10)Total score (max. 15)
      • Taylor J.L.
      • Holland D.J.
      • Keating S.E.
      • et al.
      Short-term and long-term feasibility, safety, and efficacy of high-intensity interval training in cardiac rehabilitation: the FITR heart study randomized clinical trial.
      4610
      • Piotrowicz E.
      • Pencina M.J.
      • Opolski G.
      • et al.
      Effects of a 9-week hybrid comprehensive telerehabilitation program on long-term outcomes in patients with heart failure: the telerehabilitation in heart failure patients (TELEREH-HF) randomized clinical trial.
      5914
      • Batalik L.
      • Dosbaba F.
      • Hartman M.
      • Batalikova K.
      • Spinar J.
      Benefits and effectiveness of using a wrist heart rate monitor as a telerehabilitation device in cardiac patients: A randomized controlled trial.
      5611
      • Batalik L.
      • Filakova K.
      • Batalikova K.
      • Dosbaba F.
      Remotely monitored telerehabilitation for cardiac patients: a review of the current situation.
      4812
      • Bravo-Escobar R.
      • González-Represas A.
      • Gómez-González A.M.
      • et al.
      Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: a randomised, controlled clinical trial.
      51015
      • Sibilitz K.L.
      • Berg S.K.
      • Rasmussen T.B.
      • et al.
      Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.
      4711
      • Piotrowicz E.
      • Baranowski R.
      • Bilinska M.
      • et al.
      A new model of home-based telemonitored cardiac rehabilitation in patients with heart failure: effectiveness, quality of life, and adherence.
      5813
      • Corvera-Tindel T.
      • Doering L.V.
      • Woo M.A.
      • Khan S.
      • Dracup K.
      Effects of a home walking exercise program on functional status and symptoms in heart failure.
      4610
      • Pavy B.
      • Iliou M.C.
      • Meurin P.
      • Tabet J.Y.
      • Corone S.
      Functional evaluation and cardiac rehabilitation working group of the french society of cardiology. Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation.
      3710
      mean4.37.411.8
      range3–56–109–15
      Fig. A.1
      Fig. A.1Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
      Fig. A.2
      Fig. A.2Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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