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.
Thilarajah S, Pua Y, et al. • Contemporary clinical trials • 2026
MOTIVATE is a hybrid type 1 effectiveness-implementation randomised controlled trial designed to determine whether a theory-informed, co-designed multimodal behaviour change intervention increases device-measured moderate-to-vigorous physical activity at 3 and 6 months among community-dwelling stroke survivors compared with general physical activity information.
Key Findings
Methods
The MOTIVATE trial targets community-dwelling stroke survivors who are at least 6 months post-stroke and ambulant, with the primary outcome being average daily MVPA minutes measured using Fitbit Inspire 3.
Eligible participants are adults aged ≥21 years, ≥6 months post-stroke, living at home, and ambulant with or without an aid.
The primary outcome is average daily moderate-to-vigorous physical activity (MVPA) minutes measured using Fitbit Inspire 3.
Outcomes are assessed at baseline, 3 months, and 6 months.
The trial uses concealed allocation, assessor-blinded outcomes, and intention-to-treat analysis.
Methods
The trial is powered to detect a 10-minute per day difference in MVPA between the MOTIVATE intervention and the general PA information control group.
Recruitment of 120 participants provides 80% power to detect a 10-min/day MVPA difference.
The sample size calculation allows for 20% attrition.
The allocation ratio is 1:1 in a parallel-group superiority design.
This is classified as a phase III randomised controlled trial.
Background
MOTIVATE is described as a theory-informed, co-designed behaviour change intervention intended to address gaps in effective and scalable physical activity interventions for stroke survivors.
Physical activity is identified as 'a key modifiable behaviour for secondary prevention and recovery after stroke.'
The authors note that 'effective and scalable PA interventions remain limited.'
The intervention is characterised as personalised and multimodal.
The trial also collects implementation outcomes concurrently, reported in a separate process evaluation protocol.
Methods
Secondary outcomes of the trial include additional physical activity measures, physical function, participation, and quality of life, analysed using Bayesian mixed-effects models.
Secondary outcomes encompass additional PA measures beyond MVPA, physical function, participation, and quality of life.
Analysis will use Bayesian mixed-effects models.
Self-efficacy, fatigue, mood, and sleep are collected to explore hypothesised mechanisms via post-trial mediation and moderation analyses, reported separately.
Health service utilisation is collected for economic evaluation to assess cost-effectiveness.
Methods
The trial employs a hybrid type 1 effectiveness-implementation design, meaning it primarily tests clinical effectiveness while also collecting implementation outcomes concurrently.
The design is described as 'hybrid type 1 effectiveness-implementation, phase III randomised controlled trial.'
Implementation outcomes are collected concurrently and reported in a separate process evaluation protocol.
The study is registered at ClinicalTrials.gov under NCT06409351.
The trial is categorised under secondary prevention and behaviour change.
Conclusions
The trial aims to generate evidence on both the effectiveness and cost-effectiveness of the MOTIVATE intervention for increasing physical activity after stroke.
The dual objectives are to determine whether MOTIVATE increases device-measured MVPA at 3 and 6 months and whether it is cost-effective.
Economic evaluation is conducted alongside the clinical trial using health service utilisation data.
The authors state MOTIVATE 'will provide new evidence on the effectiveness and cost-effectiveness of a co-designed, personalised behaviour change intervention to increase PA after stroke.'
The trial targets 120 participants across both arms.
What This Means
This paper describes the protocol for a clinical trial called MOTIVATE, which tests a new program designed to help stroke survivors become more physically active. The program is personalised and uses multiple strategies grounded in behaviour change theory, and was co-designed with input from stroke survivors themselves. Participants who are at least six months past their stroke, living at home, and able to walk (with or without aids) are randomly assigned either to the MOTIVATE program or to receive general information about physical activity. The main question is whether people in the MOTIVATE group do at least 10 more minutes per day of moderate-to-vigorous physical activity after 3 and 6 months, measured objectively using a Fitbit device. The trial will enrol 120 people and also assess physical function, quality of life, participation in daily life, and whether the program represents good value for money.
This research matters because physical activity after stroke is important for both recovery and reducing the risk of another stroke, yet most people who survive a stroke remain insufficiently active. Existing programs have had limited success in producing lasting changes in activity levels, and scalable solutions are still lacking. By co-designing the intervention with stroke survivors and building it on behaviour change science, the MOTIVATE team hopes to create something that works in the real world, not just in tightly controlled research settings.
This research suggests that a personalised, theory-based program delivered to community-dwelling stroke survivors could be an effective and potentially cost-effective way to increase physical activity in this population. The trial is also collecting information about how the program was implemented alongside the effectiveness data, which will help researchers and healthcare providers understand not just whether it works, but how it can be put into practice in real health systems. Results from this trial could inform future stroke rehabilitation and secondary prevention strategies.
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Thilarajah S, Pua Y, De Silva D, Thumboo J, Low L, Hollis J, et al.. (2026). 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.. Contemporary clinical trials. https://doi.org/10.1016/j.cct.2026.108441