Abstract
Background
Physical activity (PA) is a key modifiable behaviour for secondary prevention and recovery after stroke, yet effective and scalable PA interventions remain limited. MOTIVATE (Multi-mOdal Training program to promote physical actIVity After sTrokE) is a theory-informed, co-designed behaviour change intervention to address these gaps.
Aim
To determine whether MOTIVATE increases device-measured moderate-to-vigorous physical activity (MVPA) at 3 and 6 months among community-dwelling stroke survivors, compared with general PA information, and whether it is cost-effective. Implementation outcomes are collected concurrently and reported in a separate process evaluation protocol.
Methods
MOTIVATE is a hybrid type 1 effectiveness–implementation, phase III randomised controlled trial with concealed allocation, assessor-blinded outcomes and intention-to-treat analysis. Adults aged ≥21 years, ≥6 months post-stroke, living at home, and ambulant (with or without an aid) are eligible and randomised to MOTIVATE or general PA information. Outcomes are assessed at baseline, 3 and 6 months, alongside process and economic evaluations. Recruitment of 120 participants provides 80% power to detect a 10-min/day MVPA difference, allowing for 20% attrition.
Study outcomes
The primary outcome is average daily MVPA minutes measured using Fitbit Inspire 3. Secondary outcomes include additional PA measures, physical function, participation, and quality of life, analysed using Bayesian mixed-effects models. Self-efficacy, fatigue, mood, and sleep are collected to explore hypothesised mechanisms via post-trial mediation/moderation analyses, reported separately. Health service utilisation is collected for economic evaluation.
Discussion
MOTIVATE will provide new evidence on the effectiveness and cost-effectiveness of a co-designed, personalised behaviour change intervention to increase PA after stroke.
Trial design
Individually randomised, parallel-group, superiority hybrid type 1 effectiveness–implementation trial (allocation ratio 1:1).
Primary purpose
Secondary prevention/behaviour change.
Target sample size
120 Participants.
Registration
www.ClinicalTrials.gov; NCT06409351