Effectiveness of the RISE Intervention

Stroke Clinical Trial

— RISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06124248
• Other study ID #: NL83940.000.23
• Secondary ID: RAAK.PRO04.093
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2023
• Est. completion date: October 2025

Study information

• Verified date: December 2023
• Source: UMC Utrecht
• Contact: Martijn F Pisters, Dr.
• Phone: +31 6 430 42 462
• Email: m.f.pisters[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 197
• Est. completion date: October 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Sedentary Behaviour
• Stroke

Intervention

Behavioral:
• RISE intervention
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).

Locations

Country	Name	City	State
Netherlands	Fysio 4 Den Bosch	's-Hertogenbosch	Noord-Brabant
Netherlands	Fysiotherapie Beelen	Breukelen	Utrecht
Netherlands	Meras & Vital Fysiotherapie	Eersel	Noord-Brabant
Netherlands	PMC Eindhoven	Eindhoven	Noord-Brabant
Netherlands	Stroomz Prinsejagt	Eindhoven	Noord-Brabant
Netherlands	Fysiotherapie Zesgehuchten	Geldrop	Noord-Brabant
Netherlands	Fysiotherapie Rakthof	Helmond	Noord-Brabant
Netherlands	JVDI De Fysioclub	Helmond	Noord-Brabant
Netherlands	Fysiotherapie Zorgspectrum Houten eerstelijn	Houten	Utrecht
Netherlands	Fysiotherapie Groene Biezen	Ijsselstein	Utrecht
Netherlands	MTCFysio	Mijdrecht	Utrecht
Netherlands	Vivent	Rosmalen	Noord-Brabant
Netherlands	Leidsche Rijn Julius Gezondheidscentra	Utrecht
Netherlands	Van Hoof, centrum voor therapie en gezondheid	Valkenswaard	Noord-Brabant
Netherlands	Rembrandt fysiotherapie en revalidatie	Veenendaal	Utrecht
Netherlands	Fysio Annette de Gooijer	Vlijmen	Noord-Brabant
Netherlands	Fysio Vught Noord	Vught	Noord-Brabant
Netherlands	Fysiofit Vught	Vught	Brabant
Netherlands	Fysio Frankenhof	Wijk bij Duurstede	Utrecht
Netherlands	Synergy Fysiotherapie	Woerden	Utrecht
Netherlands	Van Tongeren Fysiotherapeuten	Zeist	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient characteristics	Patient characteristics will be measured with an intake questionnaire ((age, gender, education level, living situation (number of persons in the household), comorbidities, measured with CIRS (50), stroke characteristics (type of stroke, side of stroke, time since stroke) and vascular risk factors (coronary artery disease, AF, diabetes, hypertension, clinical obesity, smoking and alcohol use, hyperlipidemia).	Baseline (T0)
Other	Walking speed	Walking speed will be measured with the 5 meter walk test (5MWT) in which the participants is asked to walk 5 meters 3 times. Form the average duration of these three times the walking speed is calculated in meters per second.	Baseline (T0)
Other	Cognitive functioning	Cognitive functioning will be assessed using the Montreal Cognitive Assessment (MoCA).; MoCA assesses eight domains of cognitive functioning with small tasks. The scores range from 0-30, a score of <26 indicates impaired cognitive function.	Baseline (T0)
Other	Mental health status	Mental health status will be measured with the Hospital Anxiety and Depression Scale (HADS).; The HADS is a short questionnaire of 14 items with a 4-point Likert scale. A higher score indicates more mental health problems.	Baseline (T0) - One year post-randomisation (T4)
Other	Patients' healthcare utilization and patients' (unpaid) productivity losses	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 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".	Baseline (T0) - One year post-randomisation (T4)
Other	Compliance to the RISE intervention	Compliance to the treatment protocol will be measured with a questionnaire filled out by the physical therapists. Compliance consists of 1) the number of people that completed the intervention (with and without missing sessions); 2) The number of participants that mist one or more of the face to face sessions, the reasons for missing, and the percentage of missed sessions per participant; 3) The amount of sessions the participatory support was present; 4) The average amount of times participants used the RISE eCoaching system per week	Three months post-randomisation (T1)
Other	Safety during the RISE intervention and follow-up measurements.	Safety will be objectified by the number of adverse events registered by the researcher during the intervention and/or during the follow-up measure following the registration process.	Baseline (T0) - One year post-randomisation (T4)
Other	Health Related Quality of Life	Health Related Quality of Life will be measured with the questionnaire: EuroQol-5D (EQ-5D).; 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. 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.	Baseline (T0) - One year post-randomisation (T4)
Primary	Sedentary behaviour	Amount of sedentary time objectively measured with ActivPAL (activity monitor)	Baseline (T0) - One year post-randomisation (T4)
Secondary	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)
Secondary	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)
Secondary	Amount of light physical activity	Amount of light physical activity objectively measured with ActivPAL (activity monitor)	Baseline (T0) - One year post-randomisation (T4)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Sedentary behaviour (long term)	Amount of sedentary time objectively measured with ActivPAL	Baseline (T0) - One year post-randomisation (T4)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)