Interaction Effects of Vitamin D Supplementation and Aerobic Exercises on Balance and Physical Performance in Children With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Balance
研究概览
简要总结
Objective: To investigate the interaction effects of vitamin D supplementation and aerobic exercises on balance control and physical performance in children with Down syndrome (DS).
Methods: Forty-five children with DS ranging in age from 8 to 12 years will be selected and will participate in this study. They will be assigned randomly using sealed envelopes into three equal groups (A, B and C). Group A will consist of 15 children and will receive the conventional physical therapy program (CPTP) only. Group B will consist of 15 children and will receive the CPTP plus the aerobic exercises. Group C also will consist of 15 children and will receive the CPTP, the aerobic exercises and Vitamin D supplementation in the form of an oral dose of vitamin D3 1000 IU (Cholecalciferol). The program of treatment will be 3 days/week for 12 weeks. Evaluation of balance by using the biodex balance system and physical performance by using the six-minute walk test (6MWT) will be conducted at baseline and after 12 weeks of the treatment program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will be blinded to which each child allocated to any one of the three arms.
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with DS who can stand and walk independently
- •Children with 25 (OH) vitamin D levels of 16 ng/ml or less
- •Children who are not consuming estrogens, steroids or other medications that could interfere with vitamin D metabolism
- •The absence of visual and hearing impairments that could interfere with testing and training protocols
- •Children with mild intellectual disabilities and were capable of understanding visual and verbal instructions.
排除标准
- •Medical conditions that will severely limit a child's participation in the study as cardiac problems.
- •Musculoskeletal deformities of the lower limbs.
结局指标
主要结局
Balance
时间窗: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Balance assessment will be conducted by using the Biodex Stability System (BSS; Biodex, Inc, Shirley, NY) that enables objective assessment of balance.
Physical performance
时间窗: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Physical performance will be evaluated using the six-minute walk test (6MWT).
次要结局
未报告次要终点
研究者
Mohamed Ahmed Mahmoud Eid
Assistant Professor
Cairo University