Department of Rehabilitation Medicine, EMGO+ Institute for Health and Care Research, Research Institute MOVE, VU University Medical Center, Amsterdam, The Netherlands.
BMC Pediatr. 2010 Nov 2;10:77. doi: 10.1186/1471-2431-10-77.
Regular 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/DESIGN: This 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.
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.
This study is registered in the Dutch Trial Register as NTR2099.
定期参加体育活动对所有儿童保持健康和健康都很重要。与正常发育的儿童相比，脑瘫儿童的体育活动水平较低。LEARN 2 MOVE 7-12 研究的目的是通过体育活动刺激计划来提高体育活动水平，该计划包括生活方式干预和健身训练计划。
方法/设计：这是一项为期 6 个月的单盲随机对照试验，随访时间为 6 个月。将招募 50 名年龄在 7 至 12 岁、粗大运动功能分类系统水平为 I-III 的痉挛性脑瘫儿童，他们将在儿科物理治疗诊所和残疾儿童特殊学校招募。将儿童随机分配到干预组或对照组。对照组的儿童将继续接受常规儿科物理治疗，而干预组的儿童将参加为期 6 个月的体育活动刺激计划。体育活动刺激计划包括为期 6 个月的生活方式干预，结合为期 4 个月的健身训练计划。生活方式干预包括通过动机访谈向儿童和家长提供建议，让他们采用积极的生活方式，以及家庭为基础的物理治疗，以在日常情况下练习与移动相关的活动。数据将在干预前（T0）、4 个月健身训练计划后（T4）、6 个月生活方式干预后（T6）和 6 个月随访后（T12）收集。主要结果是通过 StepWatch 活动监测器和自我报告测量的体育活动。次要结果是健身、移动能力、社会参与和健康相关生活质量。将进行随机系数分析，以确定对照组和干预组之间治疗效果的差异，主要结果和次要结果为因变量。
这是第一项研究联合生活方式干预和健身训练对体育活动影响的研究。预计健身训练的暂时效果将通过日常生活和家庭环境中积极生活方式的改变来维持。
本研究在荷兰试验注册处注册为 NTR2099。
