Rationale and study design of multicomponent exercise intervention for frail older patients with acutely decompensated heart failure: Pilot of the randomized controlled trial J REHAB-HF trial

Background: In Japan, a growing number of older adults with heart failure (HF) are experiencing physical frailty. Healthcare providers recommend multicomponent exercise program for frail patients; however, their effectiveness in older Japanese adults with HF, who differ physiologically from their Western counterparts, remains unclear. In this study, we will compare the feasibility and efficacy of a multicomponent exercise program with those of conventional exercise therapy as pilot study of the randomized controlled trial, Japanese REHAB-HF (J REHAB-HF) trial. Methods: In this multicenter study, frail older adults hospitalized with worsening HF will be randomly assigned to participate in a program of either multicomponent or conventional exercise therapy. We developed a multicomponent exercise program to target characteristics of physical frailty: poor gait performance, balance ability, muscle strength, and exercise tolerance. The primary outcome is the total score on the Short Physical Performance Battery; additional outcome measures include feasibility and safety of the programs. Conclusion: The pilot study of the J REHAB-HF trial is an evaluation of whether a multicomponent exercise program enhances physical function more effectively than does conventional exercise therapy in frail older adults with HF. The findings will guide the design of the main J REHAB-HF trial and improve care for these individuals.