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

Area of Science:

• Rehabilitation Medicine
• Neurology
• Public Health

Background:

• A prior Phase I study confirmed the feasibility of a home-based self-management program for increasing physical activity in post-stroke individuals with mild walking disability in Brazil.
• This Phase II study builds upon Phase I findings, aiming to provide power analysis data for a future Phase III clinical trial.

Purpose of the Study:

• To evaluate the efficacy of a home-based self-management program in promoting physical activity among individuals in the acute or subacute phase of stroke with mild walking disability.
• To gather data for planning a fully-powered Phase III clinical trial.

Main Methods:

• A Phase II, randomized, controlled pilot trial involving 24 participants with concealed allocation, blinded outcome assessment, and intention-to-treat analysis.
• Participants were randomized to receive either a 6-session home-based self-management program (experimental group) or one session of stroke education plus usual care (control group).
• Physical activity was the primary outcome, measured by daily steps using an activity monitor. Secondary outcomes included cardiovascular risk, depressive symptoms, walking ability, exercise self-efficacy, social participation, and quality of life.

Main Results:

• The study is designed to compare the mean daily steps between the experimental and control groups post-intervention.
• Statistical significance for between-group differences will be determined using two-way ANOVA for parametric outcomes and the Kruskal-Wallis test for non-parametric outcomes.
• All outcomes will be measured at baseline, 12 weeks (post-intervention), and 24 weeks (follow-up).

Conclusions:

• This Phase II pilot randomized trial will provide crucial data to inform the design and power calculations for a definitive Phase III clinical trial.
• If the program demonstrates benefit, it could lead to a larger trial verifying its efficacy in enhancing physical activity and improving outcomes for stroke survivors.