The general objective of this project is to evaluate, for persons with a SCI, on the short and long term, the added value of a behavioural focused intervention, on top of a physical exercise intervention, on the level of everyday physical activity.…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The evaluation will primary contain objectively measured level of everyday
physical activity (accelerometry-based activity monitor during 5 days). This
measurement will be performed in both the FIT and Behave+FIT group at the
beginning of the intervention period (T1), at discharge from the rehabilitation
center (T2), 6 months after discharge (T3), and 1 year after discharge (T4).
Secondary outcome
Secondary parameters are: subjectively measured level of everyday physical
activity (questionnaire), the effects on physical fitness (aerobic capacity),
anthropometry (body mass index and waist circumference) and metabolic fitness
(biochemical markers). Questionnaires will be used for functionality, fatigue,
secondary problems, pain, social and sports participation, quality of life,
self-efficacy, attitude, coping, and depression. Measurements will be performed
in both groups at T1, T2, T3 and T4.
Background summary
Persons with spinal cord injury (SCI) often have an inactive lifestyle which
may result in poor physical fitness, and consequently in further inactivity. In
individuals with SCI a higher activity level has found to be associated with
less pain, fatigue and depression, with higher life satisfaction, and with
higher quality of life. Furthermore, physical activity has been associated with
a lower risk for cardiovascular disease and type 2 diabetes in individuals with
SCI. Fitness can be regarded as a prerequisite for physical activity, and is
more and more part of the regular treatment. However, a higher fitness level
will probably not automatically lead to a more active lifestyle. There is
initial evidence that behavioural interventions can improve physical activity
levels in individuals with SCI.
Study objective
The general objective of this project is to evaluate, for persons with a SCI,
on the short and long term, the added value of a behavioural focused
intervention, on top of a physical exercise intervention, on the level of
everyday physical activity. To obtain insight in the working mechanisms of the
intervention the study will specifically focus on the role of (changes in)
physical activity level and fitness level for patient well-being. We
hypothesize that the combination of a behavioural and physical exercise
intervention will lead to larger improvements in activity level compared to
only physical exercise. The addition of a behavioural intervention is expected
to be crucial for the maintenance of effects after discharge from the
rehabilitation center.
Study design
Multi-center single blind randomized controlled trial.
Intervention
The intervention will start 2 months before discharge from the rehabilitation
center. Subjects will be randomized into two groups (FIT and Behave+FIT). Both
groups receive an exercise intervention and sports advice. The Behave+FIT group
(n=30) in addition will receive a behavioural intervention. The exercise
intervention consists of a handcycle training program aimed at increasing
physical fitness (24 sessions). Sports advice consists of informing about sport
possibilities and giving the opportunity to try different kinds of sports at
the rehabilitation center or accompany when visiting another sports center. The
behavioural intervention consists of individual counseling on movement
behaviour based on motivational interviewing (13 sessions). The behavioural
intervention includes setting up action plans and coping strategies and giving
feedback by using cycle counters which can register the amount of kilometres
travelled with a wheelchair. Moreover, the intervention includes a home visit
and additional information will be provided about relevant topics related to
physical activity such as barriers and facilitators and health benefits.
Study burden and risks
All subjects will perform the handcycle training (45-60 minutes) during the
last 2 months of inpatient rehabilitation 3x/week.The Behave+FIT group will in
addition get a behavioural intervention 2x/month starting 2 months before
discharge till 3 months after discharge, and the following 3 months 1x/month.
All measurements will be performed by all subjects at 4 measurement periods.
Performing the measurements in the lab will take about 2 hours per measurement
period and filling in the questionnaires will take about another 2 hours per
measurement period. Furthermore, subjects will wear the activity monitor 4
times for 5 days, but during these periods subjects can do everything they
would normally do. All subjects will possibly benefit from the exercise
intervention with increased fitness. In addition the Behave+FIT group will
possibly benefit from the behavioural intervention with a higher activity and
fitness level on the long term.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- Recent spinal cord injury
- Between 18 and 65 years of age
- Sufficient comprehension of the Dutch language to understand the purpose of the study and its testing methods
- No progressive disease or a psychiatric condition that may interfere with participation
Exclusion criteria
- Contraindications for exercise
- Not able to perform the handcycle training intervention
- Prognosis of becoming mainly ambulatory
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL32183.078.10 |
OMON | NL-OMON29073 |