Effectiveness of the RISE Intervention

Recruiting now · Not applicable

Conditions studied: Sedentary Behaviour, Stroke

In brief

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.

Key facts

Study ID

NCT06124248

Run by

UMC Utrecht

People needed

1000

Starts

2023-11-29

Expected to finish

2027-04-01

Last updated by the study team

2024-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;
• 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 it is running

• Fysio 4 Den Bosch — 's-Hertogenbosch, North Brabant, Netherlands (enrolling)
• Meras & Vital Fysiotherapie — Eersel, North Brabant, Netherlands (enrolling)
• PMC Eindhoven — Eindhoven, North Brabant, Netherlands (enrolling)
• Stroomz Prinsejagt — Eindhoven, North Brabant, Netherlands (enrolling)
• Fysiotherapie Zesgehuchten — Geldrop, North Brabant, Netherlands (enrolling)
• JVDI De Fysioclub — Helmond, North Brabant, Netherlands (enrolling)
• Fysiotherapie Rakthof — Helmond, North Brabant, Netherlands (enrolling)
• Vivent — Rosmalen, North Brabant, Netherlands (enrolling)
• Van Hoof, centrum voor therapie en gezondheid — Valkenswaard, North Brabant, Netherlands (enrolling)
• Fysio Annette de Gooijer — Vlijmen, North Brabant, Netherlands (enrolling)
• Fysiofit Vught — Vught, North Brabant, Netherlands (enrolling)
• Fysio Vught Noord — Vught, North Brabant, Netherlands (enrolling)
• Fysiotherapie Beelen — Breukelen, Utrecht, Netherlands (enrolling)
• Fysiotherapie Zorgspectrum Houten eerstelijn — Houten, Utrecht, Netherlands (enrolling)
• Fysiotherapie Groene Biezen — IJsselstein, Utrecht, Netherlands (enrolling)
• MTCFysio — Mijdrecht, Utrecht, Netherlands (enrolling)
• Leidsche Rijn Julius Gezondheidscentra — Utrecht, Utrecht, Netherlands (enrolling)
• Rembrandt fysiotherapie en revalidatie — Veenendaal, Utrecht, Netherlands (enrolling)
• Fysio Frankenhof — Wijk bij Duurstede, Utrecht, Netherlands (enrolling)
• Synergy Fysiotherapie — Woerden, Utrecht, Netherlands (enrolling)
• Van Tongeren Fysiotherapeuten — Zeist, Utrecht, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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