Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Final polysomnography
研究概览
简要总结
Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It does multiply tenfold the occurrence of vascular events, particularly stroke. While Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term adherence to CPAP is a significant problem and search for alternative treatment is essential.
The investigators hypothesize that long-term exercise training would allow to reduce significantly sleep apnoea syndrome severity. Thus, in this study, the investigators will compare evolution of Apnoea Hypopnea Index (AHI) in an exercise trained group performed through in a national based non-profit organization (Fédération Française d'éducation Physique et de Gymnastique Volontaire (FFEPGV)) using a medical established program (NeuroGyV) during nine months against a control group receiving only standard dietetic and physical activity counseling.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients affiliated or entitled to a social security system
- •Patients with AHI from 15 to 30 per hour
- •Signature of consent
排除标准
- •Patients being already treated for sleep apnea or clinical status (cardiovascular comorbidities) justifying an immediate initiation of CPAP
- •Daytime sleepiness (ESS score > 10)
- •Known respiratory or heart disease (or discovering during stress test) contraindicated exercise training
- •Patients with Parkinson's disease
研究组 & 干预措施
Training
In this group, patients will perform 3 sessions of one hour per week of the "NeuroGyV" training program. It is a physical activity program with one session of Nordic walking, one session of "aquagym" and one session of gymnastic. Program lasts 9 months.
干预措施: Training (Other)
Control
In this group, patients will receive only diets and physical activity counselling
干预措施: Control (Other)
结局指标
主要结局
Final polysomnography
时间窗: 9 months
Percentage of patients with AHI \< 15/hour through polysomnography assessment after nine months of follow-up in the training and the control groups
次要结局
- Second intermediate polysomnography(6 months)
- High frequency(9 months)
- First intermediate polysomnography(3 months)
- Pittsburgh questionnaire(9 months)
- Maximal aerobic capacity (VO2Max)(9 months)
- Population Physical Activity questionnaire (POPAQ)(9 months)
- Epworth sleepiness Scale(9 months)
- Berlin questionnaire(9 months)
- Daily physical activity energy expenditure(9 months)
- Blood pressure - Baroreflex(9 months)