Comparison of 3 Exercise Training Modalities in Obese Patient With Sleep Apnea Syndrome Treated by Continue Positive Airway Pressure : a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in exercise tolerance during walking test
研究概览
简要总结
The study was designed to test the following hypotheses:
In obese patients with OSAS, the benefit of the combination of exercise training + continuous positive airway pressure (CPAP) will be higher than CPAP alone in term of functional capacity, metabolic, inflammatory, cardiovascular and sleep parameters and quality of life.
In obese patients with OSAS, the benefit of training using ventilatory assistance (NIV) during cycloergometer [cycloergometer with NIV] or respiratory muscles training (spirotiger) in addition to cycloergometer [cycloergometer + spirotiger] will be higher than cycloergometer training alone [cycloergometer] in term of functional and exercise capacities.
Dyspnea during walking test and respiratory muscle strength at baseline could influence the response to combined exercise training such as [cycloergometer + NIV] or [cycloergometer + spirotiger]
详细描述
Background: Obesity and sleep apnea syndrome lead to metabolic troubles and increasing cardiovascular risk. Furthermore, both diseases are associated with reduced exercise tolerance. We hypothesized that exercise training could be complementary to nocturnal ventilatory treatment in restoring metabolic disturbances, exercise tolerance and sleep parameters in obese patients with SAS.
Objective
To evaluate the effect of training on exercise tolerance (walking distance and dyspnea during walk)(main objective), systemic inflammation, vascular endothelial function, insulin resistance, quality of sleep and quality of life in obese patients treated by CPAP for OSAS (secondary objectives)
Methods: We proposed to conduct a controlled, randomized clinical trial comparing the efficacy of 3 different modalities of training in obese patients with SAS. After a 6-week control pre-inclusion period, patients are included in either [cycloergometer] vs. [cycloergometer with ventilatory assistance] vs. [cycloergometer + respiratory muscle exercises]. Before and after the control period, and both immediately and 9 month after training, patients perform walking test, maximal incremental test on cycloergometer, blood sampling and cardiovascular function, body composition, muscle function, quality of sleep and quality of life assessments as well as spontaneous physical activity measurement. During the 5 years following inclusion in the training program, the number of cardiovascular event is recorded every year.
An interim analysis will be carried out when 30 will have completed the third evaluation session (after the training program). The Peto's method will be used to correct the p-values.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OSAS (AHI > 30 before CPAP treatment)
- •> 4h/d CPAP treatment adherence
- •Obese patients with 35 < BMI < 45 kg/m2
- •Patients who give written consent
- •Patients who subscribed social insurance
排除标准
- •Cardiovascular or respiratory failure discovered at the moment of the inclusion in the study
- •Contraindication to exercise
- •Pregnant or breast-feed woman
- •Patients under guardianship
- •Imprisoned patients
研究组 & 干预措施
ERGO
General endurance training on cycloergometer
干预措施: Rehabilitation (Other)
ERGONIV/ ERGOSPIRO
General endurance training on cycloergometer using ventilatory assistance (ERGONIV) or additional respiratory muscle training (ERGOSPIRO)
干预措施: Rehabilitation (Other)
结局指标
主要结局
Change in exercise tolerance during walking test
时间窗: After control period (6th wk) vs. after training period (18th wk)
* walking distance * dyspnea score
次要结局
- Changes in Aerobic capacity(After control period (6th wk) vs. after training period (18th and 52th wks))
- Number of cardiovascular events per year(Every year from the 1st to the 5th year)
- Change in exercise tolerance during walking test(After control period (6th wk) vs. after trainng (52th wk))
- Changes in cardiovascular and metabolic function(After control period (6th wk) vs. after training period (18th and 52th wks))
- Change in physical activity and sleep duration(After control period (6th wk) vs. after training period (18th and 52th wks))
- Baseline characteristics(Before control period (1st week) or after the control period (6th week))
- Changes in sleep parameters and Quality Of life(After control period (6th wk) vs. after training period (18th and 52th wks))
- Changes in body composition(After control period (6th wk) vs. after training period (18th and 52th wks))
- Change in physiological variables during the control period(Before (1st) vs. after control period (6th wk))