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

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Netherlands
Fysio 4 Den Bosch
RECRUITING
's-hertogenbosch
Fysiotherapie Beelen
RECRUITING
Breukelen
Meras & Vital Fysiotherapie
RECRUITING
Eersel
PMC Eindhoven
RECRUITING
Eindhoven
Stroomz Prinsejagt
RECRUITING
Eindhoven
Fysiotherapie Zesgehuchten
RECRUITING
Geldrop
Fysiotherapie Rakthof
RECRUITING
Helmond
JVDI De Fysioclub
RECRUITING
Helmond
Fysiotherapie Zorgspectrum Houten eerstelijn
RECRUITING
Houten
Fysiotherapie Groene Biezen
RECRUITING
Ijsselstein
MTCFysio
RECRUITING
Mijdrecht
Vivent
RECRUITING
Rosmalen
Leidsche Rijn Julius Gezondheidscentra
RECRUITING
Utrecht
Van Hoof, centrum voor therapie en gezondheid
RECRUITING
Valkenswaard
Rembrandt fysiotherapie en revalidatie
RECRUITING
Veenendaal
Fysio Annette de Gooijer
RECRUITING
Vlijmen
Fysio Vught Noord
RECRUITING
Vught
Fysiofit Vught
RECRUITING
Vught
Fysio Frankenhof
RECRUITING
Wijk Bij Duurstede
Synergy Fysiotherapie
RECRUITING
Woerden
Van Tongeren Fysiotherapeuten
RECRUITING
Zeist
Contact Information
Primary
Martijn F Pisters, Dr.
m.f.pisters@umcutrecht.nl
+31 6 43 042 462
Backup
Camille FM Biemans
c.f.m.biemans@umcutrecht.nl
+31 6 13218777
Time Frame
Start Date: 2023-11-29
Estimated Completion Date: 2027-04
Participants
Target number of participants: 1000
Treatments
Experimental: Experimental group
RISE intervention and usual care
No_intervention: Control group
Usual care
Related Therapeutic Areas
Sponsors
Leads: UMC Utrecht

This content was sourced from clinicaltrials.gov