Background: Cardiac rehabilitation (CR) is a safe and effective intervention for individuals with cardiovascular disease (CVD). However, the majority of eligible patients do not complete CR. Growing evidence suggests that home-based CR (HBCR) programs are comparable in effectiveness and safety to traditional center-based programs. More research is needed to explore different ways to deliver HBCR programs to CVD patients.
Objective: This study aims to assess the feasibility and impact of a digital HBCR program (RecoveryPlus.Health, RPH-D) that integrates both telehealth and mHealth modalities on functional exercise capacity, resting heart rate, and quality of life among adults with cardiovascular disease (CVD).
Methods: This 12-week prospective, single-arm remote clinical trial used a within-subject design. We recruited adults with CVD (age 40+) from the community with a CR-eligible diagnosis (stable angina pectoris, myocardial infarction, heart failure, etc.) between May and August of 2023. All enrolled patients referred to the RPH clinic in Roanoke, TX were included. The care team provided guideline-concordant CR services to study participants via two modalities: 1) a synchronous telehealth exercise training via video conferencing; and 2) an asynchronous mHealth virtual coaching App (RPH App). Baseline intake survey, electronic health record (EHR), and app log data were used to extract individual characteristics, care processes, and telehealth/mHealth engagement data. Feasibility was measured by program completion rate and CR services use. Efficacy was measured by changes in 6-minute walk test (6MWT), resting heart rate, and quality of life (SF-12) before and after the 12-week program. Paired t tests were used to examine the changes in the outcome variables pre-post intervention.
Results: A total of 162 met the inclusion criteria, 75 (46.3%) consented and were enrolled. The participants' average age was 64.24 (SD 10.30) years; 37 (49%) were male, and 46 (61%) were White. Heart failure was the most common diagnosis (49%). A total of 62 (83%) participants completed the 12-week study, 62 (83%) used the telehealth modality with an average of 9.63 (SD 3.33) sessions completed, and 59 (79%) used the mHealth modality with an average of 10.97 (SD 11.70) sessions completed. Post intervention, 50 (81%) participants had improved 6MWT, with an average improvement of 40.0 meters (95% CI, 25.6 to 57.1). The average SF-12 physical and mental summary scores improved by 2.7 points (95% CI, 1.1 to 4.3) and 2.2 points (95% CI, 0.1 to 4.5), respectively. There were no changes in resting heart rate and no exercise-related adverse events were reported.
Conclusions: The RecoveryPlus.Health digital HBCR program showed feasibility and efficacy in a group of nationally recruited CVD patients. The findings add to the evidence that a telehealth and mHealth dual-modality HBCR program may be a promising approach to overcome some of the main barriers to improving CR access in the U.S.
Clinicaltrial: ClinicalTrials.gov NCT05804500.