RecruitingNot Applicable

Effectiveness of the RISE Intervention

Netherlands1,000 participantsStarted 2023-11-29

Plain-language summary

Study aim: Primarily, to investigate the effectiveness of the RISE blended behaviour change intervention in people with a first stroke to prevent major adverse cardiovascular events (i.e., recurrent stroke or TIA, acute coronary events and cardiovascular death, MACE) after 1 year follow-up compared to standard care, and cost-effectiveness. For this aim, 376 persons are enrolled in the experimental group and 376 in the control group. Considering loss to follow up, it is expected that around 950-1000 patients need to be included during baseline measurement in total. Additionally, to determine the effectiveness of the RISE intervention on reducing sedentary behaviour after discharge from acute hospital care in community dwelling people with a first-ever stroke, who have a sedentary movement behavioural pattern (so called 'sedentary prolongers' and 'sedentary movers') in comparison to usual care, at the end of the intervention period (T1). For this aim, 59 persons are enrolled in the experimental group and 59 in the control group. Considering loss to follow up, it is expected that around 197 patients need to be included during baseline measurement in total. Who can participate? People aged over 18, who return home after acute care with a first-ever stroke, who are independent in walking with or without a walking aid, will be included in the RISE intervention study. What does the study involve? In this clinical randomized controlled trial, participants with first-ever stroke and a sedentary movement pattern will be included and randomly assigned to either the experimental group who will receive RISE intervention and usual care or the control group who will receive usual care. Primary and secondary outcome will be measured at baseline, post-treatment and six, nine and 12 months post-randomisation.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is focused on reducing sedentary behavior in stroke survivors — given my current level of mobility and activity after my stroke, does my doctor think I'm a realistic candidate to discuss with the research team?
2The trial is measuring Major Adverse Cardiovascular Events as its primary outcome, which are serious events like heart attack or another stroke — what does my doctor think about my personal cardiovascular risk, and would participating in an intervention that targets sitting time actually be likely to address my specific risk factors?
3Since this study has no listed phase, it appears to be a behavioral or lifestyle intervention rather than a drug or device trial — can my doctor explain what the RISE intervention actually involves day-to-day, and how demanding would it be given where I am in my stroke recovery?
4Are there standard rehabilitation or secondary stroke prevention programs already available to me that target sedentary behavior, and how would my doctor weigh those against enrolling in this trial where the effectiveness is still being tested?
5If I join this trial and it turns out the intervention isn't working well for me, would I still be able to access other standard post-stroke care and cardiovascular risk management without any gaps?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Major Adverse Cardiovascular Events (MACE)

Timeframe: T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)

Trial details

NCT IDNCT06124248

SponsorUMC Utrecht

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Martijn F Pisters, Dr.

+31 6 43 042 462 m.f.pisters@umcutrecht.nl

View on ClinicalTrials.gov More Sedentary Behaviour trials