Heart Failure Activity Coach Study (HEALTHY): a pilot randomised controlled trial (Preprint)

BACKGROUND Heart failure (HF) is a common and deadly disease, adversely affected by physical inactivity and sedentary behaviour. An app called the Activity coach was developed to support elderly people with HF to be more physically active and less sedentary. OBJECTIVE To test recruitment frequency, implementation fidelity and feasibility of outcomes. METHODS People with HF were recruited from primary care and randomised to active or control arm. The intervention was planned for 12 weeks. Outcomes were health-related quality of life (HR-QoL), objectively measured physical activity, and subjective goal attainment. RESULTS There were 67 eligible people with HF and 30 initially agreed to participate, but 20 were successfully enrolled and randomized. The daily adherence to registering physical activity in the Activity coach was 69% [24% - 97%]. The goal attainment scores were -1.0 ± 1.1 for the control group vs 0.6 ± 0.6 for the intervention group, p = 0.001. The mean change in HR-QoL was -9 ± 10 in the control group vs 3 ± 13 in the intervention group, p = 0.027. Sedentary bout time in the control group increased by 27 minutes and decreased by 1 minute in the intervention group (p = 0.22). CONCLUSIONS Of the eligible people, 30% accepted to participate, which is a slower than anticipated. An active recruitment process is advised if a future efficacy study is to be performed. The Activity Coach may be able to support elderly people with HF in being physically active. CLINICALTRIAL ClinicalTrials.gov identifier: NCT05235763. Date of first registration: 11/02/2022.