Effectiveness of the RISE Intervention

NCT06124248 | Recruiting DMC

• 3 other identifiers: NL83940.000.23RAAK.PRO04.09310930012310010
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 21

Brief 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, 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.

Conditions

Sedentary Behaviour; Stroke

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

Outcome Measures

Primary Outcomes (1)

• 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.

  T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)

Secondary Outcomes (4)

• Cost-Effectiveness

  T0 (baseline), T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)

• Quality of life

  T0 (baseline), T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)

• Patients' healthcare utilization and patients' (unpaid) productivity losses

  T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)

• 24-hour movement behaviour (sedentary behaviour, physical activity, sleep)

  T0 (baseline), T1 (3 months), T2 (6 months), T4 (12 months)

Other Outcomes (12)

• Safety during the RISE intervention and follow-up measurements.

  T0 (baseline), T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)

• Physical functioning and participation

  T0 (baseline), T1 (3 months)

• Sleep quality and quantity

  T0 (baseline), T1 (3 months), T2 (6 months), T4 (12 months)

Study Arms (2)

Experimental group

EXPERIMENTAL

RISE intervention and usual care

Behavioral: RISE intervention

Control group

NO INTERVENTION

Usual care

Interventions

RISE intervention BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (21)

Fysio 4 Den Bosch

's-Hertogenbosch, North Brabant, 5212 VJ, Netherlands

RECRUITING

Meras & Vital Fysiotherapie

Eersel, North Brabant, 5521 JJ, Netherlands

RECRUITING

PMC Eindhoven

Eindhoven, North Brabant, 5623 BB, Netherlands

RECRUITING

Stroomz Prinsejagt

Eindhoven, North Brabant, 5624 EA, Netherlands

RECRUITING

Fysiotherapie Zesgehuchten

Geldrop, North Brabant, 5663 PZ, Netherlands

RECRUITING

JVDI De Fysioclub

Helmond, North Brabant, 5707 CA, Netherlands

RECRUITING

Fysiotherapie Rakthof

Helmond, North Brabant, 5709 EK, Netherlands

RECRUITING

Vivent

Rosmalen, North Brabant, 5244 NJ, Netherlands

RECRUITING

Van Hoof, centrum voor therapie en gezondheid

Valkenswaard, North Brabant, 5554JV, Netherlands

RECRUITING

Fysio Annette de Gooijer

Vlijmen, North Brabant, 5251 RH, Netherlands

RECRUITING

Fysiofit Vught

Vught, North Brabant, 5262 GJ, Netherlands

RECRUITING

Fysio Vught Noord

Vught, North Brabant, 5264PJ, Netherlands

RECRUITING

Fysiotherapie Beelen

Breukelen, Utrecht, 3621 BJ, Netherlands

RECRUITING

Fysiotherapie Zorgspectrum Houten eerstelijn

Houten, Utrecht, 3991 KZ, Netherlands

RECRUITING

Fysiotherapie Groene Biezen

IJsselstein, Utrecht, 3401 NG, Netherlands

RECRUITING

MTCFysio

Mijdrecht, Utrecht, 3641 KJ, Netherlands

RECRUITING

Leidsche Rijn Julius Gezondheidscentra

Utrecht, Utrecht, 3543 BZ, Netherlands

RECRUITING

Rembrandt fysiotherapie en revalidatie

Veenendaal, Utrecht, 3904 JG, Netherlands

RECRUITING

Fysio Frankenhof

Wijk bij Duurstede, Utrecht, 3962 CL, Netherlands

RECRUITING

Synergy Fysiotherapie

Woerden, Utrecht, 3447 GM, Netherlands

RECRUITING

Van Tongeren Fysiotherapeuten

Zeist, Utrecht, 3702 AD, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 40473286 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity; Cardiovascular Diseases; Sedentary Behavior

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Behavior

Study Officials

• Martijn F Pisters, Dr.

  UMC Utrecht Brain Center and Fontys University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martijn F Pisters, Dr.

CONTACT

+31 6 43 042 462; m.f.pisters@umcutrecht.nl

Camille FM Biemans

CONTACT

+31 6 13218777; c.f.m.biemans@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator who carries out the T1 follow-up measurement (end of the intervention period), will be blinded for treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: November 9, 2023
• Study Start: November 29, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: As soon as all data have been collected and analyzed, individual participant data (IPD) will be shared upon reasonable request.
• Access Criteria: No access restrictions.

Locations

NL (21)