The aim of the research is to evaluate the efficacy and working mechanisms of the "active lifestyle" intervention, which is directed to strategies to prevent low levels of daily activities and poor fitness in adolescents and young adults…
ID
Source
Brief title
Condition
- Neurological disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The level of daily activity, measured with an ambulant activity monitor.
By use of this monitor the following parameters will be calculated:
- Duration of dynamic activities
- duration of static activities
-number of transitions
- number of perionds of continuous dynamic activities
- distribution of perionds of continuous dynamic activities
- Motility (movement intensity)
2. Physicall fitness which is subdiveded into cardiorespiratory (obtained
during progressive cycling or armcranking test and 6 minute walking or
wheelchair riding test), neuromuscular (obtained with hand held dynamometry)
and metabolic fitness (obtained with heigth, waist circumference, weight, BMI
and skinfold test).
Secondary outcome
The secondary outcome measures of this study are:
Fatigue
- Fatigue severity questionnaire (FSS)
- VAS
- Checklist individual strength
Participation
- Life habits 3.0, shortened version questionnaire
Quality of life
-Short Form 36 questionnaire
Capacity for mobility related activities
- Lateral step up test (number of lateral step ups in 15 seconds).
- The Timed Stairs Test (required time to walk up and down the stairs).
- Gross motor activities (measured with the GMFM, dimension d & e).
Background summary
Prior research has found an inactive lifestyle in adolescents and young adults
with cerebral palsy and that such a lifestyle is an indicator for a poor
physical fitness and obesity. The current research focusses on promoting an
active lifestyle and improving the physical fitness by introducing a modular
build intervention. In this way the research is contributing to improvements in
medical care.
Study objective
The aim of the research is to evaluate the efficacy and working mechanisms of
the "active lifestyle" intervention, which is directed to strategies to prevent
low levels of daily activities and poor fitness in adolescents and young adults
with cerebral palsy. The intervention consists of different parts with e.g. a
physical training program en strategies to achieve a change in lifestyle with
respect to the daily activity. This intervention will be evaluated in this
longitudinal research by comparing several outcome measures between a group of
persons with CP receiving the intervention and a group of persons with CP
receiving no intervention (regular at this age). To evaluate the working
mechanisms, the focus will be on the relation between mobility related
activites, physical fitness and obesity.
Study design
In this longitudinal multicenter research an intervention will be evaluated on
adolescents with spastic CP. The measurements will take place before, during
and direct after finishing the intervention. There will be a follow-up
measurement 12 months after the start of the intervention.
The research sample will be randomly divided into two groups. The experimental
group will receive the intervention *Active Lifestyle and Sports participation*
and the control group will receive no intervention, which is regular at
adolescent age. The research assistants which will perform the measurements are
blinded for treatment allocation.
It is possible for the participant allocated to the control group, to start the
intervention after finishing the research.
Intervention
The intervention *Active Lifestyle and Sports Participation* consists of 3
parts:
1. Personal counseling; this part aims to achieve a behavioral change towards a
more active lifestyle by means of 6 individual counseling sessions with a
personal coach. This part of the intervention is based on the *Stages of
Change* concept of the transtheoretical model. This model distinguishes 5
stages and each stages needs a different approach of the personal coach to
stimulate a change in behaviour. Duration; 6 months.
2. Fitness training; this part aims to improve the physical fitness of the
participants and consists of group training sessions in the centre and home
training sessions (both 1 hour / week). The training is directed to improve the
aerobic capacity and the muscle force. Group training sessions are under
supervision of a physical therapist. Home training sessions will be monitored
by heart frequency registration. The duration of this part of the intervention
is 3 months. After this period the possibilities will be explored to continue
the training in the periphery.
3. Sports Participation; This part of the intervention consists of 2 to 5
counseling sessions with a sports counsellor where the preferences and
possibilities of sports activities are discussed. In this way the sports
counsellor can create a tailored sports advice. It is also possible to follow
several sport specific workshops. The duration of this part of the intervention
is variable with a maximum of 6 months. This part of the intervention is
optional.
An individual approch is applied during all parts of the intervention (tailored
treatment).
Study burden and risks
Burden:
During 6 months an intervention will be implemented. This intervention consists
of 6 conversations with a personal coach with respect to movement in daily
life, physical fitness training (1 hour a week grouptraining, 1 hour a week
home training) and optional modules for sportscounselling and following
sportsworkshops.
Full measurements will take place right before, right after and 6 months after
the intervention. After 3 months an additional measurement is implemented to
asses only the physical fitness.
A part of these measurements will be performed in the movement analysis
laboratory of the coöperating centres. These measurements costs 4 hours at a
time.
In the same periods as mentioned above measurements will take place in the home
situation of the participant. The measurements last for 5 days each. Our
experience is that participants do not take notion of wearing the measurement
device and can perform their regular activities during the day.
Risks:
Before the participants will be included in the research a consult with a
rehabiliation physision is planned. During this consult contra indications for
(maximal) exercise will be checked. Before testing with the maximal exercise
test the safety will be examined again with a questionnaire (PAR-Q). During the
measurements a physician is available.
's-Gravendijkwal 230
3015 CE Rotterdam
NL
's-Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
1. Spastic CP patients.
2. Adolescents and young adults (16 - 24 years).
3. Gross Motor Function Classification System (GMFCS); level I - IV will be included.
Exclusion criteria
1. Other disorders that may interfere with the measurements.
2. Contra-indication (maximal) exercise.
3. Not able to understand the purpose of the research due to insufficient knowledge of the dutch language or cognitive or any other disorders
4. High baseline level regarding physical activity
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 |
|---|---|
| CCMO | NL25102.078.09 |