Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 6 minutes walk test
研究概览
简要总结
Osteogenesis imperfecta (OI) is a rare genetic disorder of increased bone fragility and low bone mass. It is conceivable that children and adolescents with OI are less active than healthy peers because of frequent fractures, immobilization,functionals limitations and no adapted physicals activity(APA). The hypothesis is that an Adapted physique activity could improve access of activity for patients with Osteogenesis Imperfecta (OI).
The aim of the study is to evaluate benefice of APA,improve aerobic capacity, cardiovascular and bone benefits, and gain of quality of life.
Children with OI between 6 and 18 years old will have a program of supervised "adapted training program" during one year. The program is adapted at each individual and without risk for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child with osteogenesis imperfecta
- •Child followed in the Reference centre for constitutional bone diseases in the Hôpital Femme Mère Enfant
- •Parent (s) / legal guardian who has been informed of the study and has accepted participation in the study by signing the consent.
- •Patient benefiting from a social security scheme
排除标准
- •Medical and surgical contraindications to adapted physical activity.
结局指标
主要结局
6 minutes walk test
时间窗: Month 12
Distance traveled (in meters) in 6 minutes
次要结局
- Weight(Month 12)
- Height(Month 12)
- body mass index(Month 12)
- Parameters of the connected watch : calories consumption(Month 0 and Month 6 and Month 12)
- Bone mineral density(Month 12)
- blood pressure(Month 12)
- ration lean mass / fat mass(Month 12)
- Thickness intima / media(Month 0)
- Parameters of the connected watch : distance traveled(Month 0 and Month 6 and Month 12)
- Quality of life questionnaire : PedsQL(Month 12)
- Parameters of the connected watch : number of steps(Month 0 and Month 6 and Month 12)
- Ratio thickness intima / media(Month 12)
- Number of new fractures(Month 12)
- Respiratory Functional Exploration(Month 12)
- phosphocalcic biologic parameters(Month 0 and Month 12)