The aim of the present study is 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…
ID
Source
Brief title
Condition
- Other condition
- Lifestyle issues
Synonym
Health condition
Cardiovasculair, beroerte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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.
Background summary
Stroke is one of the leading causes of death and disability in the world. (ref)
About 43.000 people have a stroke each year in the Netherlands. Due to
improvements in acute care and increasing stroke incidence the amount of people
that have to live with the consequences after stroke increases. Despite the
great improvement in acute care, the risk of recurrent stroke is high, up to
40% in the first ten years. One third of the persons will have a second
cardiovascular event or even die within the first 5 years after stroke onset.
This makes secondary prevention for stroke in patients with a high-risk profile
of vital importance.
One of the key risk factors for cardiovascular events is sedentary
behaviour (ref). The definition of sedentary behaviour is: *Any waking
behaviour characterized by an energy expenditure <=1.5 Metabolic Equivalent of
Task (METs) while in a sitting, reclining or lying posture*. When sedentary
time is accumulated in prolonged bouts the increase in cardiovascular risk
factors is even higher. In general people who have had a stroke are highly
sedentary and engage in less moderate to vigorous physical activity (MVPA)
compared to their healthy peers.
Our previous study, the RISE-cohort study, showed that 78% of the
stroke population had an unfavourable movement behaviour pattern. One third of
the stroke population was highly sedentary (9.3 hours, i.e. >78% of their
waking hours), bareley interrupted their sedentary time and spent no time
engaged in MVPA. This movement pattern was defined as *sedentary prolongers*.
The other 45.8%, the so-called *sedentary movers*, do interrupt their sedentary
time more often, but still spend 63% of their time in sedentary behaviour and
hardly any time in MVPA. These results indicate that sedentary prolongers and
movers are in need of an intervention to support them to reduce and interrupt
their sedentary behaviour as a part of secondary prevention.
In the past years, our research group developed the RISE intervention.
The RISE intervention is a 15-weeks blended behavioral intervention, where a
primary care physiotherapist coaches participants to reduce and interrupt their
sedentary time.
Physiotherapists coach people with a stroke in their home setting by using
behavior change techniques and the RISE eCoaching system. The RISE eCoaching
system consists of 1) an activity monitor, 2) a smartphone application that
provides real-time feedback and contains e-learning modules, 3) a monitoring
dashboard for the physiotherapist. Participants receive participatory support
from someone from their social network (e.g., partner or close friend) who
joins them in the intervention.
A recent pilot study from our research group has shown promising results
regarding feasibility and preliminary effectivity, as well as the additional
effect of adding participatory support. In the current study, the effect of the
RISE intervention on reducing sedentary time will be further investigated in a
larger trial.
Study objective
The aim of the present study is 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.
Study design
Randomized controlled trial
Intervention
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.
Physiotherapists coach people with a stroke in their home setting by using
behavior change techniques and the RISE eCoaching system. The RISE eCoaching
system consists of 1) an activity monitor, 2) a smartphone application that
provides real-time feedback and contains e-learning modules, 3) a monitoring
dashboard for the physiotherapist. Participants receive participatory support
from someone from their social network (e.g., partner or close friend) who
joins them in the intervention.
Study burden and risks
The burden and risk of participating in the RISE intervention are considered
low. The participants will receive a blended coaching intervention to reduce
and interrupt their sedentary behaviour. The blended intervention includes ten
face-to-face sessions of a primary care physiotherapist, 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 post intervention
measurements. This includes wearing an activity monitor, questionnaires and
performing physical tests. All measurements are non-invasive. Participants can
shower and perform all other daily activities while wearing the activity
monitor. The other measurements will take about 3.5 hours in total, and will be
carried out online or at people's homes.
Included participants are physically capable of performing these physical
activities and are coached by a physiotherapist. Therefore, the risk involved
in participating is low. Additional burden of the intervention is low since
visits of the physiotherapist will be at home or online.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
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 | ISRCTNnummervolgtzodraindieningdefinitiefis |
| CCMO | NL83940.000.23 |