Effectiveness of the RISE Intervention for stroke patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of the RISE blended behaviour change intervention aimed at reducing sedentary behaviour and preventing major adverse cardiovascular events in individuals who have experienced a first stroke. Participants will be randomly assigned to either the RISE intervention group or a control group receiving standard care. The study will assess the impact of the intervention on sedentary time, physical activity levels, and overall health outcomes over a one-year follow-up period. Additionally, the trial will evaluate the cost-effectiveness and usability of the RISE intervention.

Why it matters

Who can join: the full rules

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;

Where it's running

• Fysio 4 Den Bosch
  's-Hertogenbosch, North Brabant, Netherlands Recruiting
• Meras & Vital Fysiotherapie
  Eersel, North Brabant, Netherlands Recruiting
• PMC Eindhoven
  Eindhoven, North Brabant, Netherlands Recruiting
• Stroomz Prinsejagt
  Eindhoven, North Brabant, Netherlands Recruiting
• Fysiotherapie Zesgehuchten
  Geldrop, North Brabant, Netherlands Recruiting
• JVDI De Fysioclub
  Helmond, North Brabant, Netherlands Recruiting

Study contacts

• Principal investigator: Martijn F Pisters, Dr. — UMC Utrecht Brain Center and Fontys University of Applied Sciences
• Study coordinator: Martijn F Pisters, Dr.
• Email: m.f.pisters@umcutrecht.nl
• Phone: +31 6 43 042 462

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Deep phenotyping to explore recovery in young adults after stroke

  This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.

  Recruiting The Florey Institute of Neuroscience and Mental Health · Heidelberg, Victoria and 1 other locations · NCT07019493

• Stem cell therapy for chronic stroke recovery

  This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.

  Recruiting Phase 2 Hokkaido University Hospital · Sapporo, Hokkaido · NCT06752720

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

  This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

  This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.

  Recruiting Chang Gung Memorial Hospital · Taoyuan · NCT07921108

• Remote Ischaemic Conditioning for Fatigue After Stroke 2

  Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.

  Recruiting Phase 2 Sheffield Teaching Hospitals NHS Foundation Trust · Sheffield, South Yorkshire · NCT07914647

• Dual-task balance training plus computer-based cognitive training after stroke

  In adults who recently had a stroke, the study tests whether adding computerized cognitive exercises to balance training improves balance and other recovery outcomes.

  Recruiting Matia Foundation · San Sebastián, GUIPUZCOA · NCT07913620

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.