Condition category
Circulatory System
Date applied
12/04/2019
Date assigned
27/08/2020
Last edited
28/08/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 March 2021

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martijn Pisters

ORCID ID

Contact details

Dept. of RehabilitationPhysiotherapy Science and Sport
UMC Utrecht
Utrecht University
Postbus 85500
Utrecht
3508 GA
Netherlands
-
M.F.Pisters@umcutrecht.nl

Type

Scientific

Additional contact

Dr Roderick Wondergem

ORCID ID

Contact details

Dept. of RehabilitationPhysiotherapy Science and Sport
UMC Utrecht
Utrecht University
Postbus 85500
Utrecht
3508 GA
Netherlands
-
r.wondergem@fontys.nl

Type

Public

Additional contact

Mrs Wendy Hendrickx

ORCID ID

http://orcid.org/0000-0002-0926-8869

Contact details

Dept. of RehabilitationPhysiotherapy Science and Sport
UMC Utrecht
Utrecht University
Postbus 85500
Utrecht
3508 GA
Netherlands
-
W.Hendrickx@umcutrecht.nl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Preliminary effectiveness and feasibility of the RISE intervention to reduce and interrupt sedentary behaviour in community dwelling sedentary people after stroke

Acronym

RISE intervention

Study hypothesis

The RISE intervention is feasible and leads to a significant reduction of sedentary behaviour compared to usual care.

Ethics approval

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

Study design

Pilot randomized multiple baseline design trial

Primary study design

Interventional

Secondary study design

Randomized multiple baseline design

Trial setting

Other

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

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

Phase

Drug names

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 trial start date

01/01/2020

Overall trial end date

31/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12

Participant 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

Recruitment start date

01/09/2020

Recruitment end date

01/12/2020

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Rehabilitation Physiotherapy Science and Sport, UMC Utrecht, Utrecht University
Postbus 85500
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Center Utrecht

Sponsor details

Heidelberglaan 100
Utrecht
3584 CX
Netherlands
+31 88 75 555 55
info@umcutrecht.nll

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/nl/

Funders

Funder type

Government

Funder name

Nationaal Regieorgaan Praktijkgericht Onderzoek SIA

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available.

Intention to publish date

01/09/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/08/2020: Internal review. 11/07/2019: Trial’s existence confirmed by Nationaal Regieorgaan Praktijkgericht Onderzoek SIA.