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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.

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. - RISE intervention

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56103
Enrollment
1000
Registered
2023-03-21
Start date
2023-11-29
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke (cerebral hemorrhage or cerebrovascular infarct) Stroke (cerebral hemorrhage or cerebrovascular infarct)

Interventions

Participants will receive the RISE intervention, a 15-weeks blended behavioral intervention, where a primary care physiotherapist coaches participants to reduce and interrupt their sedentary time.

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible, a subject must meet all of the following criteria: 1. Aged 18 years or older; 2. All types of 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 physiotherapeutic traject lasting >= 3 months, as determined by the physiotherapist in charge. 7. Given their written informed consent.

Exclusion criteria

Exclusion criteria: A potential subject will be excluded from participation in this study if: 1. The participant is (cognitively) not capable of understanding 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 (PAR-Q);

Design outcomes

Primary

MeasureTime frame
The aim of the present study is to determine the effectiveness of the RISE intervention on reducing sedentary behavior after discharge from acute hospital care in community dwelling people with a first-ever stroke, who have a sedentary movement behavioral pattern (so called *sedentary prolongers* and *sedentary movers*), in the first year after start of the RISE intervention, in comparison to usual care.

Secondary

MeasureTime frame
- To investigate the cost-effectiveness of the RISE blended behaviour change intervention in people with a first stroke to prevent MACE. - To determine the effectiveness of the RISE intervention on improving 24-hour activity pattern in community dwelling people with a first ever stroke, in the experimental group in comparison to usual care, at the end of the intervention period. - To determine the long-term effectiveness of the RISE intervention at six months and one year post-randomization in the experimental group in comparison to usual care. - To determine the 24-hour activity pattern (sedentary behaviour, physical activity and sleep) in community dwelling people with a first-ever stroke at baseline. - To investigate the effectiveness on self-efficacy and self-management in community dwelling people with a first-ever stroke, in the first year after start of the RISE intervention, in comparison to usual care. - To investigate the cost-effectiveness of the RISE blended behaviour change intervention in people with a first stroke to prevent MACE. - To determine the end-user satisfaction, acceptability and feasibility of the RISE application in supporting people with a first-ever stroke to reduce and interrupt their sedentary time, in participants who received the RISE intervention and in physiotherapists who delivered the RISE intervention.

Countries

Netherlands

Contacts

Public ContactM.F. Pisters

Universitair Medisch Centrum Utrecht

m.f.pisters@umcutrecht.nl+31643042462

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026