Effects of Whole-body Vibration Training on Bone Mass and Bone Metabolism in Adolescents With Down Syndrome / Efectos Del Entrenamiento Vibratorio en la Masa ósea y el Metabolismo óseo de Adolescentes Con síndrome de Down
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Changes from baseline in body composition assessed with dual energy X-ray at different time points, 6 months and 15 months.
研究概览
简要总结
The main aims of the present project include 1) to study the longitudinal effects of whole-body vibratory exercise on bone metabolism in adolescents with and without DS and 2) to evaluate whether a low frequency vibratory training program consisting of 3 sessions per week for 9 months (each vibratory session last approximately 10 minutes and includes 5-6 bouts of 1 min with 1 min rest between bouts) can improve bone development in these populations. Finally, and additional aim of the project is 3) to determine how long these effects may last after the end of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both groups: Ages 10 -
- •Both groups: Parental/guardian permission (informed consent) and if appropriate, child verbal assent.
- •Down syndrome group only: Diagnosis of Down syndrome.
排除标准
- •Taking medication affecting bone.
- •Non-caucasian.
研究组 & 干预措施
DS-NONWBV
This group will continue with their day-to-day lifestyle during the course of the project.
DS-WBV
Exercise with Whole-body vibration (WBV) platform (Power Plate®). The participants will perform squat on a vibratory platform (3 times per week; 10 repetitions 30 to 60 seconds; Frequency: 25-30 Hz; Amplitude: 2 mm).
干预措施: Whole-body vibration training (Power Plate®) on bone mass and bone metabolism in adolescents with and without Down syndrome. (Device)
NONDS-NONWBV
This group will continue with their day-to-day lifestyle during the course of the project.
NONDS-WBV
Exercise with Whole-body vibration (WBV) platform (Power Plate®). The participants will perform squat on a vibratory platform (3 times per week; 10 repetitions 30 to 60 seconds; Frequency: 25-30 Hz; Amplitude: 2 mm).
干预措施: Whole-body vibration training (Power Plate®) on bone mass and bone metabolism in adolescents with and without Down syndrome. (Device)
结局指标
主要结局
Changes from baseline in body composition assessed with dual energy X-ray at different time points, 6 months and 15 months.
时间窗: Changes from baseline in body composition at 6 months and changes from baseline in body composition at 15 months
次要结局
- Changes from baseline in bone structure evaluated with peripheral quantitative computed tomography at different time points, 6 months and 15 months.(Changes from baseline in bone structure at 6 months and changes from baseline in bone structure at 15 months)
研究者
José A. Casajús
MD, PhD.
Universidad de Zaragoza