Effects of Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change from Obstructive sleep apnea severity at 3 months.
研究概览
简要总结
The purpose of this study is to assess the effects of physical exercise, associated or not with venous compression of the leg, on obstructive sleep apnea (OSA) severity and upper airway resistance in obese teenagers. Half of the participants will undergo physical exercise and compression socks program, and the other half of subjects will undergo physical exercise program without compression socks.
详细描述
Obesity is an important factor of OSA development in children and teenagers, and physical activity is a relevant alternative to promote OSA decrease with ou without weight loss.
Physical activity, beyond the improvement of body composition and exercise cardiorespiratory capacity, restricts fluid retaining in the lower limb of the leg by the activation of musculovenous pump. Fluid retaining is involved in OSA severity because of nocturnal fluid shift from legs to rostral zone which promotes pharyngeal oedema development and upper airway collapsibility.
It has been previously shown that venous compression leads to beneficial fluid regulation in OSA subjects and appears as an efficient tool in OSA management.
To the investigators knowledge no study assess the impact of the cumulative effect of physical and venous compression program on upper airway resistances in obese teenager with OSA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese adolescents (BMI > 97th percentile),
- •patients aged from 12 to 17 years old, (born between 07/01/2003 and 09/01/1197),
- •enrolled in a pediatric obesity center with diet and physical activity programs and psychological management,
- •without observed tonsils hypertrophy (Mallampati and Friedman scores),
- •without contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography,
- •with physical activity certificate issued by a cardiologist
- •covered by the national insurance scheme of his/her legal representative,
- •having signed, as well as his(her) legal representative, the informed consent of participation.
排除标准
- •Non obese adolescents (BMI < 97th percentile)
- •patients aged under 12 or over 17 years old,
- •not enrolled in a pediatric obesity center with diet and physical activity programs and psychological management,
- •with observed tonsils hypertrophy (Mallampati and Friedman scores),
- •with contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography,
- •without physical activity certificate issued by a cardiologist
- •uncovered by the national insurance scheme of his/her legal representative,
- •not having signed, as well as his(her) legal representative, the informed consent of participation.
结局指标
主要结局
Change from Obstructive sleep apnea severity at 3 months.
时间窗: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Obstructive Sleep Apnea change will be assessed with polysomnography system at baseline and after three months
次要结局
- Body composition(This study includes 2 assessments : baseline (T0) and 3 months (T3))
- Metabolic responses(This study includes 2 assessments : baseline (T0) and 3 months (T3))
- Hormonal responses(This study includes 2 assessments : baseline (T0) and 3 months (T3))
- Inflammatory responses(This study includes 2 assessments : baseline (T0) and 3 months (T3))
- Upper airway resistances(This study includes 2 assessments : baseline (T0) and 3 months (T3))
- Fluid shift(This study includes 2 assessments : baseline (T0) and 3 months (T3))
- Anthropometric parameters(This study includes 2 assessments : baseline (T0) and 3 months (T3))
- Pulmonary function during exercise(This study includes 2 assessments : baseline (T0) and 3 months (T3))
- Calf and neck circumferences(This study includes 2 assessments : baseline (T0) and 3 months (T3))