Effectiveness of the RISE Intervention

Launched by UMC UTRECHT · Nov 8, 2023

Keywords

ClinConnect Summary

This clinical trial, called the RISE Intervention, is studying how effective a special program is in helping people who have had their first stroke to lead a healthier lifestyle and prevent serious heart-related problems, like another stroke or heart attack, over the course of a year. The trial involves 376 participants receiving the RISE program along with regular care, while another 376 participants will receive only the usual care. The goal is to see if the RISE program can help participants move more and sit less after they leave the hospital.

To take part in this study, individuals must be 18 years or older, have experienced a first stroke within the last six months, and be able to walk independently, even if they use a walking aid. Participants will be randomly assigned to either the RISE program or the usual care group. Throughout the study, participants will be asked to complete assessments at different times to track their progress. This trial is currently recruiting and aims to include a total of around 1,000 patients to ensure enough data is collected, even if some participants drop out.

Gender

ALL

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;