| NCT ID | NCT06124248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UMC Utrecht |
| Condition | Sedentary Behaviour |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-11-29 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2023-11-29 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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;
Contact & Investigator
Martijn F Pisters, Dr.
PRINCIPAL INVESTIGATOR
UMC Utrecht Brain Center and Fontys University of Applied Sciences
Frequently Asked Questions
Who can join the NCT06124248 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sedentary Behaviour. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06124248 currently recruiting?
Yes, NCT06124248 is actively recruiting participants. Contact the research team at m.f.pisters@umcutrecht.nl for enrollment information.
Where is the NCT06124248 trial being conducted?
This trial is being conducted at 's-Hertogenbosch, Netherlands, Eersel, Netherlands, Eindhoven, Netherlands, Eindhoven, Netherlands and 11 additional locations.
Who is sponsoring the NCT06124248 clinical trial?
NCT06124248 is sponsored by UMC Utrecht. The principal investigator is Martijn F Pisters, Dr. at UMC Utrecht Brain Center and Fontys University of Applied Sciences. The trial plans to enroll 1,000 participants.