Effectiveness of the RISE Intervention — RISE  

Stroke Clinical Trial

Official title: Effectiveness of the RISE Intervention to Reduce and Interrupt Sedentary Behaviour in Community Dwelling Sedentary People After First-ever Stroke

Status Recruiting

Clinical Trial Summary

Study aim:

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).

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.

Clinical Trial Description

Background and study aims Background: People who have suffered a stroke are at high risk of functional decline, recurrent stroke and premature mortality. High amounts of sedentary behaviour, accumulated in prolonged bouts and low amounts of moderate to vigorous physical activity increase the risk of cardiovascular disease. Based on earlier research it is expected that a healthier balance in the 24h activity pattern (sedentary time, physical activity and sleep) reduces the risk of a second cardiovascular event. To support patients with stroke to strike the balance in their 24h activity pattern, a behavioural change coaching intervention focusing on reducing and interrupting their sedentary time was designed. A pilot study has been performed, and the RISE intervention seems feasible in reducing sedentary behaviour in people after stroke.

Study aim: 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).

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.

What are the possible benefits and risks of participating? The possible benefits of participating in the study are: 1) insights in own movement behaviour and 2) (if someone is randomized to the RISE intervention group) the RISE intervention may help to reduce sedentary time, which may lower the risk on recurrent stroke.

The possible burden of participating in the study is that it will cost time to fulfill all questionnaires and other measurements. It will take about 45 minutes per follow-up measurement. The burden and risk of participating in the RISE intervention are considered low. The participants will receive a blended coaching intervention to reduce and interrupt their sedentary behaviour. The blended intervention includes ten face-to-face or online sessions of a primary care physiotherapist, wearing an activity monitor during the intervention period, and support from the smartphone application. During the intervention people will be encouraged to sit less and move more. The participant will participate in a baseline and post intervention measurements. This includes wearing an activity monitor, questionnaires and performing physical tests. All measurements are non-invasive. Participants can shower and perform all other daily activities while wearing the activity monitor. The other measurements will take about 3.5 hours in total, and will be carried out online or at people's homes. Included participants are physically capable of performing these physical activities and are coached by a physiotherapist. Therefore, the risk involved in participating is low. Additional burden of the intervention is low since visits of the physiotherapist will be at home or online.

Where is the study run from? Department of Rehabilitation Physiotherapy Science and Sport, University Medical Center (UMC) Utrecht, Utrecht University, Netherlands

When is the study starting and how long is it expected to run for? September 2022 to September 2026

Who is funding the study? National Directorate for Practice-oriented Research SIA (Regieorgaan Praktijkgericht Onderzoek SIA), Netherlands SIA RAAK PRO

Who is the main contact?

1. Camille Biemans, c.f.m.biemans@umcutrecht.nl (public)

2. Dr. Martijn Pisters, m.f.pisters@umcutrecht.nl (scientific) ;

Related Conditions & MeSH terms

• Sedentary Behaviour
• Stroke

• NCT number: NCT06124248
• Study type: Interventional
• Source: UMC Utrecht
• Contact: Martijn F Pisters, Dr.
• Phone: +31 6 430 42 462
• Email: m.f.pisters@umcutrecht.nl
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2023
• Completion date: October 2025