Effectiveness of the RISE Intervention
- Conditions
- StrokeSedentary Behaviour
- Interventions
- Behavioral: RISE intervention
- Registration Number
- NCT06124248
- Lead Sponsor
- UMC Utrecht
- Brief 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.
- Detailed 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 197
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.
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group RISE intervention RISE intervention and usual care
- Primary Outcome Measures
Name Time Method Major Adverse Cardiovascular Events (MACE) T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months) MACE, a composite of clinical end points of recurrent stroke or Transcient Ischaemic Attack (TIA) (definition in American Heart Association guidelines (44)), acute coronary events, and cardiovascular death. Stroke recurrence will be diagnosed by acute neurological symptoms and signs, and confirmed by magnetic resonance imaging. Acute coronary events (myocardial infarction (MI), cardiac revascularization, hospitalization with unstable angina) are diagnosed according to Consensus Conference of the European College of Cardiology and American College of Cardiology criteria (45). Deaths are regarded to be attributable to a cardiovascular cause (fatal MI, fatal stroke (i.e. death within 1 month of MI or stroke), sudden death caused by definite coronary artery disease, congestive heart failure) unless a non-cardiac death could be confirmed. This information about MACE will be collected at T1, T2, T3 and T4 using patient records from general practitioners and a questionnaire to participants.
- Secondary Outcome Measures
Name Time Method Cost-Effectiveness T0 (baseline), T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months) Assessed for MACE and quality adjusted life years (QALYs). QALYs will be based on the patients' responses to EQ 5D-5L (46). These responses will be converted into utility values using the Dutch tariff , after which QALYs will be estimated using linear interpolation between measurement points (47). All costs related to the RISE intervention will be considered: costs of intervention, other healthcare, informal care, sports, unpaid productivity, absenteeism, and presenteeism costs. Intervention costs will be micro-costed, meaning that detailed data will be gathered about the number and kinds of resources are used while providing the RISE intervention as well as information about their respective unit costs. All other costs will be measured at T0-T4 using modified versions of the iMTA Medical Consumption Questionnaire (iMCQ) and the iMTA Productivity Cost Questionnaire (iPCQ) (48). In accordance with the Dutch manual for costing studies in health care
Quality of life T0 (baseline), T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months) Health Related Quality of Life will be measured with the EuroQol-5D (EQ-5D) (50, 51) at T0, T1, T2, T3 and T4. This questionnaire comprises of 5 dimensions i.e., mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Per dimension, patients are asked to indicate their health status on a 5-point Likert scale (1 = no problems; 5 = extreme problems). The health states can be converted into utility units by means of the Dutch rates (52). Utilities represent quality of life into a single number that ranges from 0 (death) to 1 (full health). Quality Adjusted Life Years (QALY's) can subsequently be calculated by multiplying the patients' utilities by the duration of time they spent in that particular health status.
Patients' healthcare utilization and patients' (unpaid) productivity losses T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months) Patients' healthcare utilization and patients' (unpaid) productivity losses will be measured using cost questionnaires.
There will be made use of retrospective 3-month cost questionnaires (at T1, T2, T3 and T4) to avoid recall bias. Healthcare utilization will be valued using Dutch standards costs (56). If these are unavailable, prices reported by professional organizations will be used. will be valued in accordance with the "Dutch Manual of Costing".24-hour movement behaviour (sedentary behaviour, physical activity, sleep) T0 (baseline), T1 (3 months), T2 (6 months), T4 (12 months) 24-hour movement behaviour consists of movement behaviour (sedentary time and physical activity) and sleep. 24-hour movement behaviour is measured with the ActivPAL (PAL Technologies Ltd, Glasgow, United Kingdom) at T0, T1, T2 and T4 (34). This monitor is combination of a triaxial accelerometer and inclinometer, worn on the anterior side of the unaffected thigh, and detects if someone is either sedentary (sitting, lying or reclining), standing or walking. The ActivPAL is sealed in a waterproof sleeve and attached to the skin using hypoallergic tape. Participants are instructed to wear the ActivPAL for eight consecutive days. The first 24 hour of the data will be removed in order to counteract a possible Hawhorne effect (53). This ActivPAL is reliable (Intraclass correlation coefficient 0.79-0.99) and valid (98-100% accuracy) for measuring sedentary time and posture transitions during daily life in people with stroke (41-43).
Trial Locations
- Locations (21)
Fysio 4 Den Bosch
🇳🇱's-Hertogenbosch, Noord-Brabant, Netherlands
Fysiofit Vught
🇳🇱Vught, Brabant, Netherlands
Meras & Vital Fysiotherapie
🇳🇱Eersel, Noord-Brabant, Netherlands
Fysiotherapie Zesgehuchten
🇳🇱Geldrop, Noord-Brabant, Netherlands
PMC Eindhoven
🇳🇱Eindhoven, Noord-Brabant, Netherlands
Stroomz Prinsejagt
🇳🇱Eindhoven, Noord-Brabant, Netherlands
JVDI De Fysioclub
🇳🇱Helmond, Noord-Brabant, Netherlands
Fysiotherapie Rakthof
🇳🇱Helmond, Noord-Brabant, Netherlands
Vivent
🇳🇱Rosmalen, Noord-Brabant, Netherlands
Van Hoof, centrum voor therapie en gezondheid
🇳🇱Valkenswaard, Noord-Brabant, Netherlands
Fysio Annette de Gooijer
🇳🇱Vlijmen, Noord-Brabant, Netherlands
Fysio Vught Noord
🇳🇱Vught, Noord-Brabant, Netherlands
Fysiotherapie Beelen
🇳🇱Breukelen, Utrecht, Netherlands
Fysiotherapie Zorgspectrum Houten eerstelijn
🇳🇱Houten, Utrecht, Netherlands
Fysiotherapie Groene Biezen
🇳🇱Ijsselstein, Utrecht, Netherlands
MTCFysio
🇳🇱Mijdrecht, Utrecht, Netherlands
Rembrandt fysiotherapie en revalidatie
🇳🇱Veenendaal, Utrecht, Netherlands
Fysio Frankenhof
🇳🇱Wijk bij Duurstede, Utrecht, Netherlands
Leidsche Rijn Julius Gezondheidscentra
🇳🇱Utrecht, Netherlands
Synergy Fysiotherapie
🇳🇱Woerden, Utrecht, Netherlands
Van Tongeren Fysiotherapeuten
🇳🇱Zeist, Utrecht, Netherlands