Effectiveness of the RISE Intervention

Study Overview
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Brief Summary
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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
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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? Camille Biemans, c.f.m.biemans@umcutrecht.nl (public) Dr. Martijn Pisters, m.f.pisters@umcutrecht.nl (scientific)

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

Conditions
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Sedentary Behaviour, Stroke

Intervention / Treatment
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* Behavioral: RISE intervention


Participation Criteria
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Eligibility Criteria
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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: 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. Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>RISE intervention and usual care | Behavioral: RISE intervention<br>* The RISE intervention: a 15-weeks blended behavioral intervention, where a primary care physiotherapist coaches participants on striking the balance in their 24h activity pattern, with a focus on reducing and interrupting their sedentary time. This will subsequently lead to an increase in physical activity. Next to that, insights into their personal sleep pattern, sleep hygiene rules and advices will be provided. Primary care physiotherapists coach people with a first-ever stroke in their home setting by using behavior change techniques and the RISE eCoaching system. The RISE eCoaching system consists of 1) an activity monitor, 2) a smartphone application that provides real-time feedback and contains e-learning modules, 3) a monitoring dashboard for the physiotherapist. Participants receive participatory support from someone from their social network (e.g., partner or close friend) who joins them in the intervention (see image 1).<br>|
| No Intervention: Control group<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedentary behaviour | Amount of sedentary time objectively measured with ActivPAL (activity monitor) | Baseline (T0) - One year post-randomisation (T4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fragmentation of sedentary behaviour | The fragmentation index of sedentary behaviour objectively measured with ActivPAL (PAL Technologies Ltd, Glasgow, United Kingdom, activity monitor). | Baseline (T0) - One year post-randomisation (T4) | 
| Sedentary time interruption | The sedentary time interruption (amount of sedentary bouts, average sedentary bout duration, percentage of sedentary time accumulated in bouts over 30 min and 60 min) will be objectively measured with ActivPAL (PAL Technologies Ltd, Glasgow, United Kingdom, activity monitor). | Baseline (T0) - One year post-randomisation (T4) | 
| Amount of light physical activity | Amount of light physical activity objectively measured with ActivPAL (activity monitor) | Baseline (T0) - One year post-randomisation (T4) | 
| Amount of moderate to vigorous physical activity | Amount of moderate to vigorous physical activity objectively measured with ActivPAL (activity monitor) | Baseline (T0) - One year post-randomisation (T4) | 
| Self-management | Self-management measured with questionnaire: Patient Activation Measure (PAM). The Pam 13-Dutch is a reliable 13-item instrument and assesses patient (or consumer) self-reported knowledge, skills and confidence for self-management of one's health or chronic condition. The answering categories per item are 4-point Likert scales, ranging from totally disagree to totally agree and 'non applicable'. A higher score (range 1-100) indicates a higher level of self-management. | Baseline (T0) - One year post-randomisation (T4) | 
| Self-efficacy | Self-efficacy measured with questionnaire: Self-Efficacy Symptom Management Scale (SESx). This questionnaire consists of 13 items scored on a 10-point scale ranging from 'not confident at all' to 'completely confident'. A higher score indicating higher self-efficacy. | Baseline (T0) - One year post-randomisation (T4) | 
| Sedentary behaviour (long term) | Amount of sedentary time objectively measured with ActivPAL | Baseline (T0) - One year post-randomisation (T4) | 
| End-user satisfaction of the RISE eCoaching system | End-user satisfaction of the RISE eCoaching system will be measured with questionnaire: End-User Computing Satisfaction (EUCS). The EUCS is a 12-item questionnaire to measure end-use computing satisfaction of the (experimental group) participant and physiotherapists about usage of the RISE eCoaching system. All items are scored with a 5-point Likert scale ('almost never' to 'almost always'). | Three months post-randomisation (T1) | 
| Acceptability of the RISE eCoaching system | Acceptability of the RISE eCoaching system will be measured with questionnaire: Post-Study System Usability Questionnaire (PSSUQ). The PSSUQ is a 19-item instrument that assesses the perceived satisfaction of a user with a system, in this case the RISE eCoaching system. | Three months post-randomisation (T1) | 
| Usability of the RISE eCoaching system | Usability of the RISE eCoaching system will be measured with questionnaire: System Usability Scale (SUS). The SUS is a questionnaire that measures the perceived usability of the m-health part of the intervention by posing 10 statements which the participant can rate on a 5-points Likert scale ('completely agree' to 'completely disagree'). The score ranges from 0-100, with a higher score indicating a higher perceived usability. | Three months post-randomisation (T1) | 
| Sleep quality | Sleep quality will be objectively measured with the Emfit QS Sleep tracker (Emfit Ltd, Vaajakoski, Finland; 542 3 70 3 1.4 mm). Next to the Emfit QS, experienced sleep quality is measured with the Pittsburgh Sleep Quality Index (PSQI). ThePSQI is a 19-item self-reported questionnaire about experienced sleep quality in the past month. | Baseline (T0) - One year post-randomisation (T4) | 
| Sleep quantity | Sleep quantity will be objectively measured with the Emfit QS Sleep tracker (Emfit Ltd, Vaajakoski, Finland; 542 3 70 3 1.4 mm) | Baseline (T0) - One year post-randomisation (T4) | 
| Level of fatigue | Level of fatigue will be measured with questionnaire: Fatigue Severity Scale-7 (FSS-7). The items are asked about the past few weeks and relate to the perceived severity of fatigue in different daily situations. The FSS-7 measures chronic fatigue in 7 items with a 7-point likert scale (ranging from 'totally disagree' to 'totally agree'). The final score is the mean of the 7 item scores. A final score of ≥4 indicates that the severity of fatigue has a medium to high impact on daily life. | Baseline (T0) - One year post-randomisation (T4) | 
| Physical functioning and participation | Physical functioning and participation will be measured using the Short Physical Performance Battery (SPPB). The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons, which gives insight in someone's walking speed, balance and leg strength. The SPPB consists of a balance test, a gait speed test and a chair stand test, of which each item is score with 1, 2 or 4 points. The maximal total score is 12, in which a higher score indicates better lower extremity functioning. | Baseline (T0) - Three months post-randomisation (T1) | 
| Stroke physical impact | Stroke physical impact will be measured with questionnaire: Stroke Impact Scale (SIS). This questionnaire has 37 questions in 5 domains (strength, hand function, activities daily living /Instrumental activities daily living, mobility and participation/ role and function). In this study, the domain 'activities daily living' is used. These questions are answered on a 5-point Likert scale ranging from 1, negative (e.g. 'no strength at all' or 'extremely difficult'), to 5 (e.g. 'a lot of strength' or 'not difficult at all'). | Baseline (T0) - One year post-randomisation (T4) | 
| 24h activity pattern (sedentary behaviour, physical activity and sleep) | Change in sleep quantity, amount of time spent sedentary, amount of time spent in light physical activity and amount of time spent moderate to vigorous physical activity will be combined to report the 24h activity pattern. | Baseline (T0) - One year post-randomisation (T4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Movement behaviours, Sedentary behaviour, Physical activity, Cardiovascular diseases, Sedentary time, Sitting time, Behaviour change