Dataset Information

Evaluation of the efficacy and safety of an integrated telerehabilitation platform for home-based cardiac REHABilitation in patients with heart failure (E-REHAB): protocol for a randomised controlled trial.

ABSTRACT:

Introduction

Cardiac rehabilitation (CR) is strongly recommended as a medical treatment to improve the prognosis and quality of life of patients with heart failure (HF); however, participation rates in CR are low compared with other evidence-based treatments. One reason for this is the geographical distance between patients' homes and hospitals. To address this issue, we developed an integrated telerehabilitation platform, RH-01, for home-based CR. We hypothesised that using the RH-01 platform for home-based CR would demonstrate non-inferiority compared with traditional centre-based CR.

Methods and analysis

The E-REHAB trial aims to evaluate the efficacy and safety of RH-01 for home-based CR compared with traditional centre-based CR for patients with HF. This clinical trial will be conducted under a prospective, randomised, controlled and non-inferiority design with a primary focus on HF patients. Further, to assess the generalisability of the results in HF to other cardiovascular disease (CVD), the study will also include patients with other CVDs. The trial will enrol 108 patients with HF and 20 patients with other CVD. Eligible HF patients will be randomly assigned to either traditional centre-based CR or home-based CR in a 1:1 fashion. Patients with other CVDs will not be randomised, as safety assessment will be the primary focus. The intervention group will receive a 12-week programme conducted two or three times per week consisting of a remotely supervised home-based CR programme using RH-01, while the control group will receive a traditional centre-based CR programme. The primary endpoint of this trial is change in 6 min walk distance.

Ethics and dissemination

The conduct of the study has been approved by an institutional review board at each participating site, and all patients will provide written informed consent before entry. The report of the study will be disseminated via scientific fora, including peer-reviewed publications and presentations at conferences.

Trial registration number

jRCT:2052200064.

SUBMITTER: Chimura M

PROVIDER: S-EPMC10450078 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

Evaluation of the efficacy and safety of an integrated telerehabilitation platform for home-based cardiac REHABilitation in patients with heart failure (E-REHAB): protocol for a randomised controlled trial.

Chimura Misato M Koba Shinji S Sakata Yasushi Y Ise Takayuki T Miura Hiroyuki H Murai Ryosuke R Suzuki Hiroshi H Maekawa Emi E Kida Keisuke K Matsuo Koki K Kondo Hirokazu H Takabayashi Kensuke K Fujimoto Wataru W Tamura Yuichi Y Imai Shunsuke S Miura Shin-Ichiro SI Origuchi Hideki H Goda Akiko A Saita Ryotaro R Kikuchi Atsushi A Taniguchi Tatsunori T

BMJ open 20230824 8

<h4>Introduction</h4>Cardiac rehabilitation (CR) is strongly recommended as a medical treatment to improve the prognosis and quality of life of patients with heart failure (HF); however, participation rates in CR are low compared with other evidence-based treatments. One reason for this is the geographical distance between patients' homes and hospitals. To address this issue, we developed an integrated telerehabilitation platform, RH-01, for home-based CR. We hypothesised that using the RH-01 pl ...[more]

PMID: 37620273

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Project description:BackgroundDue to improved treatments and ageing population, many countries now report increasing prevalence in rates of ischemic heart disease and heart failure. Cardiac rehabilitation has potential to reduce morbidity and mortality, but not all patients complete. In light of favourable effects of cardiac rehabilitation it is important to develop patient education methods which can enhance adherence to this effective program. The LC-REHAB study aims to compare the effect of a new patient education strategy in cardiac rehabilitation called 'learning and coping' to that of standard care. Further, this paper aims to describe the theoretical basis and details of this intervention.Methods/designOpen parallel randomised controlled trial conducted in three hospital units in Denmark among patients recently discharged with ischemic heart disease or heart failure. Patients are allocated to either the intervention group with learning and coping strategies incorporated into standard care in cardiac rehabilitation or the control group who receive the usual cardiac rehabilitation program. Learning and coping consists of two individual clarifying interviews, participation of experienced patients as educators together with health professionals and theory based, situated and inductive teaching. Usual care in cardiac rehabilitation is characterised by a structured deductive teaching style with use of identical pre-written slides in all hospital units. In both groups, cardiac rehabilitation consists of training three times a week and education once a week over eight weeks. The primary outcomes are adherence to cardiac rehabilitation, morbidity and mortality, while secondary outcomes are quality of life (SF-12, Health education impact questionnaire and Major Depression Inventory) and lifestyle and risk factors (Body Mass Index, waist circumference, blood pressure, exercise work capacity, lipid profile and DXA-scan). Data collection occurs four times; at baseline, at immediate completion of cardiac rehabilitation, and at three months and three years after the finished program.DiscussionIt is expected that learning and coping incorporated in cardiac rehabilitation will improve adherence in cardiac rehabilitation and may decrease morbidity and mortality. By describing learning and coping strategies the study aims to provide knowledge that can contribute to an increased transparency in patient education in cardiac rehabilitation.Trial registrationIdentifier NCT01668394.

Project description:ObjectivesTo quantify the impact of a home-based cardiac rehabilitation intervention (Rehabilitation Enablement in Chronic Heart Failure (REACH-HF)) on objectively assessed physical activity (PA) of patients with heart failure (HF) and explore the extent by which patient characteristics are associated with a change in PA.DesignSecondary analysis of randomised controlled trial data.SettingFive centres in the UK.Participants247 patients with HF (mean age 70.9±10.3 years; 28% women).InterventionsREACH-HF versus usual care (control).Primary and secondary outcome measuresPA was assessed over 7 days via GENEActiv triaxial accelerometer at baseline (pre-randomisation), post-intervention (4 months) and final follow-up (6-12 months). Using HF-specific intensity thresholds, intervention effects (REACH-HF vs control) on average min/day PA (inactivity, light PA and moderate-to-vigorous PA (MVPA)) over all days, week days and weekend days were examined using linear regression analysis. Multivariable regression was used to explore associations between baseline patient characteristics and change in PA.ResultsAlthough there was no difference between REACH-HF and control groups in 7-day PA levels post-intervention or at final follow-up, there was evidence of an increase in weekday MVPA (10.9 min/day, 95% CI: -2.94 to 24.69), light PA (26.9 min/day, 95% CI: -0.05 to 53.8) and decreased inactivity (-38.31 min/day, 95% CI: -72.1 to -4.5) in favour of REACH-HF. Baseline factors associated with an increase in PA from baseline to final follow-up were reduced MVPA, increased incremental shuttle walk test distance, increased Hospital Anxiety and Depression Scale anxiety score and living with a child >18 years (p<0.05).ConclusionsWhile participation in the REACH-HF home-based cardiac rehabilitation intervention did not increase overall weekly activity, patient's behaviour patterns appeared to change with increased weekday PA levels and reduced inactivity. Baseline PA levels were highly predictive of PA change. Future focus should be on robust behavioural changes, improving overall levels of objectively assessed PA of people with HF.Trial registration numbersISRCTN78539530 and ISRCTN86234930.

Project description:AimsDespite strong recommendations, outpatient cardiac rehabilitation is underused in chronic heart failure (CHF) patients. Possible barriers are frailty, accessibility, and rural living, which may be overcome by telerehabilitation. We designed a randomized, controlled trial to evaluate the feasibility of a 3-month real-time, home-based telerehabilitation, high-intensity exercise programme for CHF patients who are either unable or unwilling to participate in standard outpatient cardiac rehabilitation and to explore outcomes of self-efficacy and physical fitness at 3 months post-intervention.Methods and resultsCHF patients with reduced (≤40%), mildly reduced (41-49%), or preserved ejection fraction (≥50%) (n = 61) were randomized 1:1 to telerehabilitation or control in a prospective controlled trial. The telerehabilitation group (n = 31) received real-time, home-based, high-intensity exercise for 3 months. Inclusion criteria were (i) ≥18 years, (ii) New York Heart Association class II-III, stable on optimized medical therapy for >4 weeks, and (iii) N-terminal pro-brain natriuretic peptide >300 ng/L. All participants participated in a 2-day 'Living with heart failure' course. No other intervention beyond standard care was provided for controls. Outcome measures were adherence, adverse events, self-reported outcome measures, the general perceived self-efficacy scale, peak oxygen uptake (VO2peak ) and a 6-min walk test (6MWT). The mean age was 67.6 (11.3) years, and 18% were women. Most of the telerehabilitation group (80%) was adherent or partly adherent. No adverse events were reported during supervised exercise. Ninety-six per cent (26/27) reported that they felt safe during real-time, home-based telerehabilitation, high-intensity exercise, and 96% (24/25) reported that, after the home-based supervised telerehabilitation, they were motivated to participate in further exercise training. More than half the population (15/26) reported minor technical issues with the videoconferencing software. 6MWT distance increased significantly in the telerehabilitation group (19 m, P = 0.02), whereas a significant decrease in VO2peak (-0.72 mL/kg/min, P = 0.03) was observed in the control group. There were no significant differences between the groups in general perceived self-efficacy scale, VO2peak , and 6MWT distance after intervention or at 3 months post-intervention.ConclusionsHome-based telerehabilitation was feasible in chronic heart failure patients inaccessible for outpatient cardiac rehabilitation. Most participants were adherent when given more time and felt safe exercising at home under supervision, and no adverse events occurred. The trial suggests that telerehabilitation can increase the use of cardiac rehabilitation, but the clinical benefit of telerehabilitation must be evaluated in larger trials.

Dataset Information

Evaluation of the efficacy and safety of an integrated telerehabilitation platform for home-based cardiac REHABilitation in patients with heart failure (E-REHAB): protocol for a randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Evaluation of the efficacy and safety of an integrated telerehabilitation platform for home-based cardiac REHABilitation in patients with heart failure (E-REHAB): protocol for a randomised controlled trial.

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