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Effectiveness of the RISE Intervention for stroke patients

RISE Intervention: Heading to Sustainable Movement Behavioural Change in People with Stroke

Not applicable Interventional UMC Utrecht · NCT06124248

This study tests if a new program called RISE can help stroke survivors move more and reduce their risk of serious heart problems compared to standard care.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorUMC Utrecht Academic / other
Locations21 sites ('s-Hertogenbosch, North Brabant and 20 other locations)
Trial IDNCT06124248 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of the RISE blended behaviour change intervention aimed at reducing sedentary behaviour and preventing major adverse cardiovascular events in individuals who have experienced a first stroke. Participants will be randomly assigned to either the RISE intervention group or a control group receiving standard care. The study will assess the impact of the intervention on sedentary time, physical activity levels, and overall health outcomes over a one-year follow-up period. Additionally, the trial will evaluate the cost-effectiveness and usability of the RISE intervention.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced a first-ever stroke within the last six months and have a sedentary movement pattern.

Not a fit: Patients with severe comorbidities that prevent safe participation or those unable to understand the intervention content due to cognitive limitations may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the risk of recurrent strokes and other cardiovascular events in stroke survivors.

How similar studies have performed: Previous studies have shown promise in using behaviour change interventions to reduce sedentary behaviour in stroke patients, suggesting that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

In order to be eligible to participate in the baseline measurement of the intervention study, a subject must meet all of the following criteria:

1. Aged 18 years or older;
2. All types of first-ever stroke diagnosed in hospital within six months before start of the RISE intervention;
3. Able to walk independently, as defined by a Functional ambulation categories score of at least 3;
4. Independent regarding activities of daily living pre-stroke, as defined by a Barthel Index score of \>18;
5. Discharged to the home-setting;
6. Not participating in a physical rehabilitation program lasting ≥ 3 months;
7. Given their written informed consent.

Exclusion Criteria:

A potential subject will be excluded from participation in this study if:

1. The participant has insufficient knowledge or is cognitively unable to understand the Dutch language of the intervention content;
2. The participant has severe comorbidities that withhold that person from safely reducing and interrupting their sedentary time (e.g. sever pulmonary diseases, hart failure or malignity's) as determined with the Physical Activity Readiness Questionnaire;

Where this trial is running

's-Hertogenbosch, North Brabant and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Sedentary BehaviourStrokePhysical activityCardiovascular diseasesSedentary timeSitting timeMovement behavioursBehaviour change
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.