Status:

RECRUITING

Effectiveness of the RISE Intervention

Lead Sponsor:

UMC Utrecht

Conditions:

Sedentary Behaviour

Stroke

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

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 l...

Eligibility Criteria

Inclusion

  • 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

  • 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;

Key Trial Info

Start Date :

November 29 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2027

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT06124248

Start Date

November 29 2023

End Date

April 1 2027

Last Update

October 1 2024

Active Locations (21)

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Page 1 of 6 (21 locations)

1

Fysio 4 Den Bosch

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

2

Meras & Vital Fysiotherapie

Eersel, North Brabant, Netherlands, 5521 JJ

3

PMC Eindhoven

Eindhoven, North Brabant, Netherlands, 5623 BB

4

Stroomz Prinsejagt

Eindhoven, North Brabant, Netherlands, 5624 EA

Effectiveness of the RISE Intervention | DecenTrialz