Abstract
BackgroundRegular participation in physical activities is important for all children to stay fit and healthy. Children with cerebral palsy have reduced levels of physical activity, compared to typically developing children. The aim of the LEARN 2 MOVE 7-12 study is to improve physical activity by means of a physical activity stimulation program, consisting of a lifestyle intervention and a fitness training program.Methods/DesignThis study will be a 6-month single-blinded randomized controlled trial with a 6-month follow up. Fifty children with spastic cerebral palsy, aged 7 to 12 years, with Gross Motor Function Classification System levels I-III, will be recruited in pediatric physiotherapy practices and special schools for children with disabilities. The children will be randomly assigned to either the intervention group or control group. The children in the control group will continue with their regular pediatric physiotherapy, and the children in the intervention group will participate in a 6-month physical activity stimulation program. The physical activity stimulation program consists of a 6-month lifestyle intervention, in combination with a 4-month fitness training program. The lifestyle intervention includes counseling the child and the parents to adopt an active lifestyle through Motivational Interviewing, and home-based physiotherapy to practise mobility-related activities in the daily situation. Data will be collected just before the start of the intervention (T0), after the 4-month fitness training program (T4), after the 6-month lifestyle intervention (T6), and after six months of follow-up (T12). Primary outcomes are physical activity, measured with the StepWatch Activity Monitor and with self-reports. Secondary outcomes are fitness, capacity of mobility, social participation and health-related quality of life. A random coefficient analysis will be performed to determine differences in treatment effect between the control group and the intervention group, with primary outcomes and secondary outcomes as the dependent variables.DiscussionThis is the first study that investigates the effect of a combined lifestyle intervention and fitness training on physical activity. Temporary effects of the fitness training are expected to be maintained by changes to an active lifestyle in daily life and in the home situation.Trial registrationThis study is registered in the Dutch Trial Register as NTR2099.
Highlights
Regular participation in physical activities is important for all children to stay fit and healthy
This is the first study that investigates the effect of a combined lifestyle intervention and fitness training on physical activity
Temporary effects of the fitness training are expected to be maintained by changes to an active lifestyle in daily life and in the home situation
Summary
This is the first study of children with CP that investigates the effects of a combined intervention on physical activity, by focusing on a change in lifestyle and improvement in fitness. The separate elements of the intervention (lifestyle intervention [counseling and home-based physiotherapy] and fitness training) are expected to reinforce improvements in fitness and physical activity, resulting in sustained effects on physical activity one year after the start of the intervention. Temporary effects of the fitness training are expected to be maintained by changes to an active lifestyle in daily life and in the home situation. A possible limitation of the study is that effects cannot be assigned to a specific element of the intervention By assessing both physical activity and fitness outcomes, as well as the attitude of the child and the parents towards physical activity, more insight can be gained in the inter-relationship of these outcomes
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