Sedentary BehaviourRISENCT06124248
Effectiveness of the RISE Intervention
A study testing RISE intervention in people with Sedentary Behaviour and Stroke, run by UMC Utrecht at 21 sites in Netherlands.
Trial summary
Study aim: Primarily, to investigate the effectiveness of the RISE blended behaviour change intervention in people with a first stroke to prevent major adverse cardiovascular events (i.e., recurrent stroke or TIA, acute coronary events and cardiovascular death, MACE) after 1 year follow-up compared to standard care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedentary Behaviour, Stroke
- What is being tested?
- RISE intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 21 sitesNetherlands
- Study dates
- 29 Nov 2023to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
Netherlands21 sites, 21 recruiting
- Recruiting
Fysio 4 Den Bosch
's-Hertogenbosch, North Brabant, 5212 VJ
Eline Geurts
- Recruiting
Fysiotherapie Beelen
Breukelen, Utrecht, 3621 BJ
Martje Jans
- Recruiting
Meras & Vital Fysiotherapie
Eersel, North Brabant, 5521 JJ
Tamara van Leeuwarden
- Recruiting
PMC Eindhoven
Eindhoven, North Brabant, 5623 BB
Marjolein Dings
- Recruiting
Stroomz Prinsejagt
Eindhoven, North Brabant, 5624 EA
Bram van Gompel
- Recruiting
Fysiotherapie Zesgehuchten
Geldrop, North Brabant, 5663 PZ
Evelien Mulder
- Recruiting
JVDI De Fysioclub
Helmond, North Brabant, 5707 CA
Laura Pleiter
- Recruiting
Fysiotherapie Rakthof
Helmond, North Brabant, 5709 EK
Jenny Bijsterbosch
- Recruiting
Fysiotherapie Zorgspectrum Houten eerstelijn
Houten, Utrecht, 3991 KZ
Marielle Wittekamp
- Recruiting
Fysiotherapie Groene Biezen
IJsselstein, Utrecht, 3401 NG
Jelmer Klomp
- Recruiting
MTCFysio
Mijdrecht, Utrecht, 3641 KJ
Esther Verdam
- Recruiting
Vivent
Rosmalen, North Brabant, 5244 NJ
José Martens
- Recruiting
Leidsche Rijn Julius Gezondheidscentra
Utrecht, Utrecht, 3543 BZ
Sander Perry
- Recruiting
Van Hoof, centrum voor therapie en gezondheid
Valkenswaard, North Brabant, 5554JV
Wencke van Deurzen
- Recruiting
Rembrandt fysiotherapie en revalidatie
Veenendaal, Utrecht, 3904 JG
Tessa Hodes
- Recruiting
Fysio Annette de Gooijer
Vlijmen, North Brabant, 5251 RH
Jytte Blenkers
- Recruiting
Fysiofit Vught
Vught, North Brabant, 5262 GJ
Yvon Hagoort
Nikita Huijgens
- Recruiting
Fysio Vught Noord
Vught, North Brabant, 5264PJ
Iris van Bussel
- Recruiting
Fysio Frankenhof
Wijk bij Duurstede, Utrecht, 3962 CL
Liselot De Bruijn-Oechies
- Recruiting
Synergy Fysiotherapie
Woerden, Utrecht, 3447 GM
Martje Jans
- Recruiting
Van Tongeren Fysiotherapeuten
Zeist, Utrecht, 3702 AD
Annemarie de Wissel
About this study
Official title: RISE Intervention: Heading to Sustainable Movement Behavioural Change in People with Stroke
Study aim:
Primarily, to investigate the effectiveness of the RISE blended behaviour change intervention in people with a first stroke to prevent major adverse cardiovascular events (i.e., recurrent stroke or TIA, acute coronary events and cardiovascular death, MACE) after 1 year follow-up compared to standard care, and cost-effectiveness. For this aim, 376 persons are enrolled in the experimental group and 376 in the control group. Considering loss to follow up, it is expected that around 950-1000 patients need to be included during baseline measurement in total.
Read more
Additionally, 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). For this aim, 59 persons are enrolled in the experimental group and 59 in the control group. Considering loss to follow up, it is expected that around 197 patients need to be included during baseline measurement in total.
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.
Read the detailed description
Rationale: 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.
Objective: To determine the effectiveness of the RISE intervention on preventing major adverse cardiovascular effects (MACE), after discharge from acute hospital care in community dwelling people after first-ever stroke, who have a sedentary movement behavioural pattern. In addition, the effects on 24h activity pattern, cost-effectiveness, and usability of the RISE intervention will be investigated.
Study design: 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 outcomes will be measured at baseline, post-treatment (four months), and six, nine, and 12 months post-randomisation.
Study population: 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.
Intervention (if applicable): Participants will receive the RISE intervention, a 15-weeks blended behavioural 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 behaviour 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).
Participants in the control group receive usual care, according to hospital specific guidelines.
Main study parameters/endpoints: Effectiveness of RISE intervention on preventing major adverse cardiovascular events.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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
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.
- Conditions
- Sedentary Behaviour, Stroke
- Being tested
- RISE intervention
- Keywords
- Physical activity, Cardiovascular diseases, Sedentary time, Sitting time, Movement behaviours, Behaviour change, Sedentary behaviour, Stroke, Secondary prevention, Costs, Cost analysis, Cost effectiveness, MACE, Prevention
- Medical subject headings
- Stroke, Motor Activity, Cardiovascular Diseases, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RISE interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | RISE intervention and usual care Receives: Behavioral: RISE intervention |
| Control group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
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.
Measured: T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)
Secondary outcomes (4)
Cost-Effectiveness
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
Measured: T0 (baseline), T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)
Quality of life
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.
Measured: T0 (baseline), T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)
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 (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".
Measured: T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)
24-hour movement behaviour (sedentary behaviour, physical activity, sleep)
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).
Measured: T0 (baseline), T1 (3 months), T2 (6 months), T4 (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start29 Nov 2023
- Primary completionSep 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary BehaviourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martijn F. Pisters, PhD, PT, UMC Utrecht
- Investigators
- Martijn F Pisters, Dr., Principal investigator, UMC Utrecht Brain Center and Fontys University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124248
- Sponsor's protocol ID
- NL83940.000.23
- Other IDs
- RAAK.PRO04.093, 10930012310010
- Acronym
- RISE
- Status last verified
- Sep 2024
- First submitted
- 13 Oct 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized data will be available upon reasonable request.
Publications
Biemans CFM, Hartman YAW, Broers S, Pagen S, Hendrickx W; RISE Study Group; van Dongen JM, Verschuren OW, English C, Veenhof C, Visser-Meily JMA, Pisters MF. Secondary prevention by striking the balance in 24-hour movement behaviour by empowering people at risk with a stroke: rationale and design of the RISE intervention randomised controlled trial. BMJ Open. 2025 Jun 5;15(6):e094894. doi: 10.1136/bmjopen-2024-094894.
PubMed 40473286
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RISE Intervention: Heading to Sustainable Movement Behavioural Change in People with Stroke
- ClinicalTrials.gov ID
- NCT06124248
- Acronym / sponsor ID
- RISE / NL83940.000.23
- Conditions
- Sedentary Behaviour, Stroke
- Keywords
- Physical activity, Cardiovascular diseases, Sedentary time, Sitting time, Movement behaviours, Behaviour change, Sedentary behaviour, Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study aim:
Primarily, to investigate the effectiveness of the RISE blended behaviour change intervention in people with a first stroke to prevent major adverse cardiovascular events (i.e., recurrent stroke or TIA, acute coronary events and cardiovascular death, MACE) after 1 year follow-up compared to standard care, and cost-effectiveness. For this aim, 376 persons are enrolled in the experimental group and 376 in the control group. Considering loss to follow up, it is expected that around 950-1000 patients need to be included during baseline measurement in total.
Additionally, 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). For this aim, 59 persons are enrolled in the experimental group and 59 in the control group. Considering loss to follow up, it is expected that around 197 patients need to be included during baseline measurement in total.
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
Rationale: 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.
Objective: To determine the effectiveness of the RISE intervention on preventing major adverse cardiovascular effects (MACE), after discharge from acute hospital care in community dwelling people after first-ever stroke, who have a sedentary movement behavioural pattern. In addition, the effects on 24h activity pattern, cost-effectiveness, and usability of the RISE intervention will be investigated.
Study design: 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 outcomes will be measured at baseline, post-treatment (four months), and six, nine, and 12 months post-randomisation.
Study population: 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.
Intervention (if applicable): Participants will receive the RISE intervention, a 15-weeks blended behavioural 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 behaviour 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).
Participants in the control group receive usual care, according to hospital specific guidelines.
Main study parameters/endpoints: Effectiveness of RISE intervention on preventing major adverse cardiovascular events.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: RISE interventionRISE intervention and usual care |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RISE interventionThe 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. | Behavioural | Experimental group |
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: 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.
4 secondary outcomes
Cost-Effectiveness
Time frame: T0 (baseline), T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)
Quality of life
Time frame: T0 (baseline), T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)
Patients' healthcare utilization and patients' (unpaid) productivity losses
Time frame: T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)
24-hour movement behaviour (sedentary behaviour, physical activity, sleep)
Time frame: T0 (baseline), T1 (3 months), T2 (6 months), T4 (12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Derived from this study: PubMed 40473286Biemans CFM, Hartman YAW, Broers S, Pagen S, Hendrickx W; RISE Study Group; van Dongen JM, Verschuren OW, English C, Veenhof C, Visser-Meily JMA, Pisters MF. Secondary prevention by striking the balance in 24-hour movement behaviour by empowering people at risk with a stroke: rationale and design of the RISE intervention randomised controlled trial. BMJ Open. 2025 Jun 5;15(6):e094894. doi: 10.1136/bmjopen-2024-094894.
- Individual participant dataSharing planned: Yes. Pseudonymized data will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martijn F Pisters, Dr. principal investigator
UMC Utrecht Brain Center and Fontys University of Applied Sciences
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RISE intervention in people with Sedentary Behaviour and Stroke, run by UMC Utrecht at 21 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martijn F Pisters, Dr. (+31 6 43 042 462, m.f.pisters@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06124248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.