Tests a blended behaviour change program to reduce sitting after stroke
Tests the RISE program to help people after a first stroke sit less.
Plain-language title generated from the registry record
Registry title: Effectiveness of the RISE Intervention
Key facts
- Where
- 's-Hertogenbosch, Breukelen, Eersel, Eindhoven, Geldrop, Helmond, Houten, IJsselstein, Mijdrecht, Rosmalen, Utrecht, Valkenswaard, Veenendaal, Vlijmen, Vught, Wijk bij Duurstede, Woerden, and Zeist, NetherlandsSee the 21 sites
Where in Netherlands
- Fysio 4 Den Bosch's-Hertogenbosch, NetherlandsTaking people
- Fysiotherapie BeelenBreukelen, NetherlandsTaking people
- Meras & Vital FysiotherapieEersel, NetherlandsTaking people
- PMC EindhovenEindhoven, NetherlandsTaking people
- Stroomz PrinsejagtEindhoven, NetherlandsTaking people
- Fysiotherapie ZesgehuchtenGeldrop, NetherlandsTaking people
- Fysiotherapie RakthofHelmond, NetherlandsTaking people
- JVDI De FysioclubHelmond, NetherlandsTaking people
- Fysiotherapie Zorgspectrum Houten eerstelijnHouten, NetherlandsTaking people
- Fysiotherapie Groene BiezenIJsselstein, NetherlandsTaking people
- MTCFysioMijdrecht, NetherlandsTaking people
- ViventRosmalen, NetherlandsTaking people
- Leidsche Rijn Julius GezondheidscentraUtrecht, NetherlandsTaking people
- Van Hoof, centrum voor therapie en gezondheidValkenswaard, NetherlandsTaking people
- Rembrandt fysiotherapie en revalidatieVeenendaal, NetherlandsTaking people
- Fysio Annette de GooijerVlijmen, NetherlandsTaking people
- Fysio Vught NoordVught, NetherlandsTaking people
- Fysiofit VughtVught, NetherlandsTaking people
- Fysio FrankenhofWijk bij Duurstede, NetherlandsTaking people
- Synergy FysiotherapieWoerden, NetherlandsTaking people
- Van Tongeren FysiotherapeutenZeist, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UMC Utrecht
- Trial code
- NCT06124248
- Record updated
- 1 October 2024
- Original description
Study aim:Read full original descriptionShow less
RISE Intervention: Heading to Sustainable Movement Behavioural Change in People with Stroke
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.
Inclusion: In order to be eligible to participate in the baseline measurement of the intervention study, a subject must meet all of the following 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: 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; A potential subject will be excluded from participation in this study if:; The participant has insufficient knowledge or is cognitively unable to understand the Dutch language of the intervention content.