Multi-mOdal Training program to promote physical actIVity After sTrokE (MOTIVATE): Protocol for effectiveness and economic outcomes in a hybrid type 1 effectiveness-implementation randomised controlled trial.

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.