RISE-Intervention for reducing sedentary behaviour after stroke
| ISRCTN | ISRCTN10694741 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10694741 |
- Submission date
- 12/04/2019
- Registration date
- 27/08/2020
- Last edited
- 12/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Stroke is one of the leading causes of death and disability worldwide. One in three of the people that survive the first stroke have a recurrent stroke or pass away within five years. Therefore secondary prevention aimed at reducing important risk factors such as high blood pressure, impaired glucose tolerance and unhealthy lifestyle (smoking and physical inactivity) is of vital importance.
The importance of physical activity after stroke is well known and integrated into usual care and treatment guidelines. Recent research has shown that high amounts of sedentary behaviour ( time during the day spend sitting, lying or reclining) increase the risk of cardiovascular disease and death, even when someone spends sufficient amount of time in moderate to vigorous physical activities. Sedentary behaviour is most harmful if this is accumulated over 10 hours a day and in prolonged bouts and physical activity levels are low. For people with high amounts of sedentary behaviour accumulated in prolonged bouts an intervention to help people reduce their sedentary behaviour once they return home after having a stroke seem highly relevant.
A blended care intervention was developed using the behaviour change wheel and the CEHRES model. Elements will be eCoaching technologies, self-monitoring and face to face contact with a physiotherapist to support behavioural change. The intervention was developed in co-design with people with stroke, physiotherapist, physicians, technology experts and experts in the field of behavioural change and sedentary behaviour. The RISE intervention is 15 weeks and combines face to face coaching sessions by a physiotherapist with eCoaching by using an activity monitor and a m-health application. The aim of this study is to determine the preliminary effectiveness and the feasibility of the RISE intervention to reduce and interrupt sedentary behaviour in the first 6 months after discharge from hospital in community people with a first ever stroke. The secondary aim is to investigate the added value and feasibility of integrating participatory support within the RISE intervention. In participatory support (PS) a member of the participant’s immediate social environment provides meaningful support. This member participates as a buddy in the intervention.
Who can participate?
Males and females aged over 18 who have suffered a first-ever stroke, who are independent in walking with or without a walking aid and have a sedentary and inactive movement pattern.
What does the study involve?
The study involves testing the preliminary effectiveness and feasibility of the RISE Intervention with and without PS. Participants will be randomized to either the RISE Intervention with PS or without PS after being included into the study. Participants will wear an activity monitor 4-14 days before, during and 4-14 days after the intervention to measure sedentary behaviour and physical activity. Also after the intervention participants will be asked to complete a questionnaire and to participate in an interview to determine the satisfaction with the intervention.
What are the possible benefits and risks of participating?
The possible benefit is that a reduction in sedentary behaviour might reduce the cardio metabolic risk factors like high blood pressure and glucose tolerance. This can prevent recurrent stroke, other cardiovascular diseases and mortality and decline in physical functions. The goal of the intervention is to replace sedentary behaviour by normal daily activities (light intensity physical activities), therefore the risk involved in participating is low.
Where is the study run from?
Department of Rehabilitation Physiotherapy Science and Sport, UMC Utrecht, Utrecht University, Netherlands
When is the study starting and how long is it expected to run for?
January 2021 to June 2022
Who is funding the study?
National Directorate for Practice-oriented Research SIA (Regieorgaan Praktijkgericht Onderzoek SIA), Netherlands
Who is the main contact?
1. Wendy Hendrickx, W.Hendrickx@umcutrecht.nl (public)
2. Dr Martijn Pisters, M.F.Pisters@umcutrecht.nl (scientific)
3. Dr Roderick Wondergem, r.wondergem@fontys.nl
Contact information
Scientific
Dept. of RehabilitationPhysiotherapy Science and Sport
UMC Utrecht
Utrecht University
Postbus 85500
Utrecht
3508 GA
Netherlands
| M.F.Pisters@umcutrecht.nl |
Scientific
Dept. of RehabilitationPhysiotherapy Science and Sport
UMC Utrecht
Utrecht University
Postbus 85500
Utrecht
3508 GA
Netherlands
| r.wondergem@fontys.nl |
Public
Dept. of RehabilitationPhysiotherapy Science and Sport
UMC Utrecht
Utrecht University
Postbus 85500
Utrecht
3508 GA
Netherlands
 ORCID ID |
0000-0002-0926-8869 |
|---|---|
| W.Hendrickx@umcutrecht.nl |
Study information
| Study design | Pilot randomized multiple baseline design trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomized multiple baseline design |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Preliminary effectiveness and feasibility of the RISE intervention to reduce and interrupt sedentary behaviour in community dwelling sedentary people after stroke |
| Study acronym | RISE intervention |
| Study objectives | The RISE intervention is feasible and leads to a significant reduction of sedentary behaviour compared to usual care. |
| Ethics approval(s) | Approved 01/07/2020 Medical Ethical Board of the University Medical Centre Utrecht (Heidelberglaan 100 3584CX, Utrecht, Netherlands; +31 88 75 56 376; info@metcutrecht.nl), ref: 20/250 |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | Participants will receive the RISE intervention, a blended movement behaviour change intervention that aims to support them to reduce and interrupt their sedentary time. The blended intervention is 15 weeks and combines face to face coaching sessions by a physiotherapist with eCoaching by using an activity monitor and a m-health application. Six of the 12 participants will be randomized to participate in the RISE intervention including participatory support (PS). In participatory support (PS) a member of the participant’s immediate social environment provides meaningful support. This member participates as a buddy in the intervention. The participants buddy will get insight in relevant self-management information (e.g. why reducing sedentary time and increasing physical activity is important in people with stroke), the individual goals of the participant and how to provide meaningful support. By performing the same movement behavioural change tasks in reducing and interrupting sedentary behaviour as the participant, the buddy will be able to facilitate changes, provide encouragement support, increase enjoyment and provide greater accountability for a more active lifestyle. Participants will be randomized by an independent researcher to either the experimental group or the usual care group by a computer-generated random sequence table generated using SPSS. For both groups the outcome measures will be conducted in the same manner. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 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 | 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 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 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 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 |
| Overall study start date | 01/01/2020 |
| Completion date | 01/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 12 |
| Total final enrolment | 14 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2020 |
| Date of final enrolment | 30/11/2021 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Utrecht
3508 GA
Netherlands
Sponsor information
Hospital/treatment centre
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
| Phone | +31 88 75 555 55 |
|---|---|
| info@umcutrecht.nll | |
| Website | http://www.umcutrecht.nl/nl/ |
"ROR" |
https://ror.org/0575yy874 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Nationaal Regieorgaan Praktijkgericht Onderzoek, National Board of Practice-Oriented Research SIA, National Board of Practice-Oriented Research, Regieorgaan SIA, NRPO-SIA
- Location
- Netherlands
Results and Publications
| Intention to publish date | 30/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 25/07/2024 | 12/08/2024 | Yes | No |
Editorial Notes
12/08/2024: Publication reference added.
17/04/2024: The intention to publish date was changed from 30/04/2024 to 30/08/2024.
19/01/2024: The intention to publish date was changed from 30/01/2024 to 30/04/2024.
20/11/2023: The intention to publish date was changed from 30/11/2023 to 30/01/2024.
19/06/2023: The intention to publish date was changed from 30/06/2023 to 30/11/2023.
17/03/2023: The intention to publish date was changed from 31/03/2023 to 30/06/2023.
15/02/2022: The following changes have been made:
1. The final enrolment number has been added.
2. The overall trial end date has been changed from 28/02/2022 to 01/06/2022 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 01/06/2022 to 31/03/2023.
16/11/2021: The recruitment end date was changed from 01/11/2021 to 30/11/2021.
15/09/2021: The inclusion criteria were changed.
20/07/2021: The recruitment end date was changed from 31/07/2021 to 01/11/2021.
04/06/2021: The inclusion criteria were changed.
18/05/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/05/2021 to 31/07/2021.
2. The overall end date was changed from 31/03/2022 to 28/02/2022.
23/02/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2021 to 31/05/2021.
2. The overall trial end date was changed from 31/03/2021 to 31/03/2022.
3. The intention to publish date was changed from 01/09/2021 to 01/06/2022.
4. The inclusion criteria were updated.
09/12/2020: The recruitment end date was changed from 01/12/2020 to 31/03/2021.
28/08/2020: Internal review.
11/07/2019: Trial’s existence confirmed by Nationaal Regieorgaan Praktijkgericht Onderzoek SIA.
