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 dwelling sedentary…
ID
Source
Brief title
Condition
- Other condition
- Lifestyle issues
Synonym
Health condition
Cardiovasculair, beroerte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Preliminary effectiveness of the intervention on sedentary behaviour; total
amount of sedentary time and the sedentary time fragmentation.
2. Feasibility of the intervention; compliance, satisfaction and safety.
Secondary outcome
Secondary study outcome:
1. Preliminary effectiveness of the intervention with PS on sedentary
behaviour; total amount of sedentary time and the sedentary time fragmentation
2. Feasibility of the intervention with PS; compliance and safety
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.
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.
Background summary
People who have suffered a stroke are at high risk of functional decline,
recurrent stroke and premature mortality. Therefore, secondary prevention is
urgent. High amounts of sedentary behaviour, accumulated in prolonged bouts and
low amounts of moderate to vigorous physical activity increase the risk of
cardiovascular disease. In total 32% of the people with stroke have such a
movement behaviour pattern called sedentary prolongers.
To support sedentary prolongers reduce and interrupt their sedentary time a
behavioural change coaching intervention delivered by a physiotherapist, called
the RISE intervention, was designed. It was designed using the behaviour change
wheel in a co-design process with people with stroke, physiotherapist working
with people with stroke and experts in the field of sedentary behaviour and
stroke.
Study objective
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
dwelling sedentary prolongers with a first ever stroke. The secondary aim is to
investigate 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. 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.
Study design
A prospective multiple baseline study. The design will include randomization to
the intervention delivery with or without participatory support and the
duration of baseline measurements (either 4, 6, 8, 10, 12 or 14 days).
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. A self-chosen person from their immediate
social environment (e.g. their partner, close family member or friend) will
participate in the RISE intervention including participatory support.
Study burden and risks
The burden and risk of participating in the RISE intervention are deemed low.
The participants will receive a blended coaching intervention to reduce and
interrupt their sedentary behavior. The blended intervention includes ten
face-to-face sessions, wearing an activity monitor during the intervention
period, and support from the smartphone application. During the intervention
people will be encouraged to sit less and move more. The participant will
participate in a baseline and a post intervention measurements. This includes
wearing an activity monitor, questionnaires and performing the five meter
walking test (only at baseline). Patient and stroke characteristics will be
obtained from the medical records. After finishing the intervention
participants will be asked to participate in a semi-structured interview to
determine their experiences and satisfaction with the intervention. The goal of
the intervention is to replace sedentary behavior by normal daily activities
(light intensity physical activities), therefore the risk involved in
participating is low. Additional the burden of the intervention is low since
physiotherapist will visit the participant at home.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
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.
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, hart 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN10694741 |
| CCMO | NL73036.041.20 |