RISE-Intervention for reducing sedentary behaviour after stroke

Not Applicable

Completed

• Conditions: Stroke; Circulatory System; Cerebral infarction

• Registration Number: ISRCTN10694741
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39124608/ (added 12/08/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-27
• Study Completion: 2022-06-01
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Current inclusion criteria as of 15/09/2021:
1. Aged 18 years or older
2. Stroke diagnosed in hospital within six months of the start of the RISE intervention
3. Able to walk independently, as defined by a functional ambulation categories score of at least 3
4. Sedentary prolonger; i.e. =9.5 hours of sedentary time per day and meeting at least one of the following criteria: >50% of the sedentary time is spent in bouts > 30 minutes and not reaching the physical activity guideline (150 minutes MVPA during the week)
5. Independent regarding activities of daily living pre-stroke, as defined by a Barthel Index score of >18
6. Discharged to the home-setting
7. Have someone who can participate as a bubby in the RISE intervention with PS
8. Given their written informed consent

Previous inclusion criteria as of 04/06/2021:
1. Aged 18 years or older
2. Stroke diagnosed in hospital within six months of the start of the RISE intervention
3. Able to walk independently, as defined by a functional ambulation categories score of at least 3
4. Sedentary prolonger; =9.5 hours of sedentary time per day, >50% of the sedentary time is spent in bouts > 30 minutes and not reaching the physical activity guideline (150 minutes MVPA during the week)
5. Independent regarding activities of daily living pre-stroke, as defined by a Barthel Index score of >18
6. Discharged to the home-setting
7. Have someone who can participate as a bubby in the RISE intervention with PS
8. Given their written informed consent

Previous inclusion criteria as of 23/02/2021:
1. Aged 18 years or older
2. First-ever stroke diagnosed in hospital within 6 months of the start of the RISE intervention
3. Able to walk independently, as defined by a functional ambulation categories score of at least 3
4. Sedentary prolonger; =9.5 hours of sedentary time per day, >50% of the sedentary time is spent in bouts > 30 minutes and not reaching the physical activity guideline (150 minutes MVPA during the week)
5. Independent regarding activities of daily living pre-stroke, as defined by a Barthel Index score of >18
6. Discharged to the home-setting
7. Have someone who can participate as a bubby in the RISE intervention with PS
8. Given their written informed consent

Previous inclusion criteria:
1. Aged 18 years or older
2. First ever stroke diagnosed in hospital in last 3 months
3. Able to walk independently, as defined by a functional ambulation categories score of at least 3
4. Sedentary prolonger; =9.5 hours of sedentary time per day, >50% of the sedentary time is spent in bouts > 30 minutes and not reaching the physical activity guideline (150 minutes MVPA during the week)
5. Independent regarding activities of daily living pre-stroke, as defined by a Barthel Index score of >18
6. Discharged to the home-setting
7. Have someone who can participate as a bubby in the RISE intervention with PS
8. Given their written informed consent

Exclusion Criteria

1. Insufficient knowledge of the Dutch language to understand the intervention content
2. Score <4 on the Utrecht Communication Assessment (UCO) to understand questionnaires and follow instructions
3. Severe comorbidities that prevent that person from safely reducing and interrupting their sedentary time (e.g. sever pulmonary diseases, heart failure or malignity’s) as determined with the Physical Activity Readiness Questionnaire (PAR-Q)
4. Not receiving physiotherapy in any other setting then primary care

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Preliminary effectiveness of the intervention on sedentary behaviour; total amount of sedentary time and the sedentary time fragmentation, assessed using the ActivPAL activity monitor over the 15 week period<br>2. Feasibility of the intervention; compliance, satisfaction and safety, assessed using inclusion and adherence registration, semi-structured interviews and the System Usability Scale post-intervention

Secondary Outcome Measures

Name	Time	Method
1. Preliminary effectiveness of the intervention with PS on sedentary behaviour; total amount of sedentary time and the sedentary time fragmentation, assessed using the ActivPAL activity monitor over the 15 week period<br>2. Feasibility of the intervention with PS; compliance and safety, assessed using inclusion and adherence registration semi-structured interviews and the System Usability Scale post-intervention<br>3. Preliminary effectiveness of the intervention on non-sedentary movement behaviour; the amount of light and moderate to vigorous physical activity, the step count and the time spent standing and/or walking. Assessed using the ActivPAL activity monitor over the 15 week period<br>4. Other study parameters: participant characteristics, sleep duration and quality, happiness, tiredness, stress, pain, time pressure, the inclusion rate, time consumption of the intervention and the study and the activity monitor data and the usage of the different parts of the app during the intervention period