Home-based self-management for sedentary individuals with mild walking disability after stroke: protocol for a randomized pilot study

Abstract

Abstract Background A Phase I study showed that is feasible to implement a home-based self-management program aimed at increasing physical activity in individuals after stroke with mild impairments in Brazil. The next step is to test this program against a control group in order to provide a power analysis for a fully-powered Phase III clinical trial. Methods A Phase II pilot randomized clinical trial with concealed allocation, blinded measurement, and intention-to-treat analyses will be carried out. The inclusion criteria will be: individuals who had suffered a stroke, in the acute or subacute phase, with mild impairments, sedentary, and with no significant language impairment. The individuals will be randomly allocated to the experimental or control group. The experimental group will receive 6 sessions of a home-based self-management program, based on behaviour change techniques, over 11 weeks. The control group will receive education about stroke, orientation regarding the importance of practicing physical activity after a stroke and usual care. A total of 24 participants will be recruited. The primary outcome will be physical activity, measured through steps taken per day by an activity monitor (Actigraph wGT3X-BT, Pensacola, FL, USA). Secondary outcomes will be cardiovascular risk (body mass index, waist circumference, and blood pressure), depressive symptoms (Geriatric Depression Scale), walking ability (6-Minute Walk Test and 10-Meter Walk Test), exercise self-efficacy (Self-Efficacy for Exercise scale), social participation (Stroke Impact Scale) and quality of life (EuroQual-5D). All outcomes will be measured at baseline (Week 0), post-intervention (Week 12), and follow-up (Week 24). This pilot clinical trial was registered online at Clinical Trials under number NCT05461976 in 4th April, 2022. Discussion If beneficial, this Phase II pilot randomized trial will provide data to plan a fully powered future Phase III clinical trial aimed at verifying the efficacy of this program to promote physical activity after stroke. Trial registration: Clinical Trials NCT05461976.