Randomized Clinical Trial on the Effect of an Aerobic Exercise Program in Patients With Moderate-severe Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Change of the variable AHI measured by polygraphy
研究概览
简要总结
In this paper, it is postulated that in sedentary patients with moderate-severe sleep apnea diagnosed by a sleep test, an increase in physical activity stimulated by the use of a pedometer during a period of 6 months can reduce the severity of OSAS by decreasing the number of respiratory events during sleep and when controlling for vascular risk factors.
详细描述
It is postulated that in sedentary patients with moderate to severe sleep apnea, an increase in physical activity can reduce the severity of OSAS.
Our main objective was to determine the effectiveness of a physical exercise program to reduce the number of respiratory disorders during sleep (AHI) in patients with moderate-severe OSAS. The primary outcome variable will be the decrease in the AHI at least 50% of its baseline value.
Secondary objectives were:
- To evaluate the impact of a physical activity program on glucose metabolism (glycemia, insulinemia, glycosylated hemoglobin, HOMA index).
- Determine the effect of the physical activity program on the lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides, apolipoproteins A1 and B).
- Assess the role of a physical activity program on the systolic and diastolic blood pressure.
- Determine the effect of a physical activity program on body weight (BMI).
- To analyze the effect of a physical activity program on the perception of the impact of sleep on daily life (FOSQ questionnaire).
It is a controlled, randomized and parallel group clinical trial with an allocation ratio of 1: 1 For randomization, a table of random numbers with sampling module of the Epidat 3.1 program will be prepared by a statistician who does not participate in the study.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years.
- •Low physical activity (total duration <60 minutes / week or a physical activity index calculated using the YPAS scale <51).
- •An AHI> 15 and <30 / hour or AHI> 30 and rejection of CPAP.
- •Signature of the informed consent form.
排除标准
- •Suspicion or knowledge of a chronic disease that prevents a physical exercise program.
研究组 & 干预措施
Control
The usual physical activity valued by the YPAS questionnaire (Yale Physical Activity Survey) will be maintained. The questionnaire allows to calculate the time in physical activity expressed in hours / week, the energy expenditure expressed in MET-h / week and the summary index of physical activity that takes into account the frequency and duration of physical activity and oscillates from 0 to 137. A value below 51 identifies sedentary patients. Daily physical activity is controlled through a pedometer that measures the distance traveled daily by the patient and recorded in a walking book.
The therapeutic control will be carried out by telephone call at the second and fourth month of treatment and a face-to-face clinical control at 3 and 6 months.
干预措施: Physical activity (Other)
Intervention
It is intended that the exercise program have a duration of 6 months and its realization does not suppose an excessive consumption of resources. Therefore, it must have a series of characteristics: low supervision and easily realizable by all patients, which implies flexibility in the schedule and without the need for instruments or special facilities. In this sense the walk is adjusted to these assumptions and the goal of 10.000 steps / day can encourage compliance.
The subjects assigned to the intervention group will be supervised and trained by a physiotherapist who will explain the training program and resolve the doubts raised by the patient.
Daily physical activity is controlled through a pedometer that measures the distance traveled daily by the patient and recorded in a walking book.
The therapeutic control will be carried out by telephone call at the second and fourth month of treatment and a face-to-face clinical control at 3 and 6 months.
干预措施: Physical activity (Other)
结局指标
主要结局
Change of the variable AHI measured by polygraphy
时间窗: six months
Decrease in the value of the AHI after a physical exercise program
次要结局
- Change in systolic and diastolic blood pressure values after a physical activity program.(six months)
- Change on body weight after a physical activity program(six months)
- Modification of daytime sleepiness after a physical activity program.(six months)
- Changes on the lipid profile after a physical activity program(six months)
- Changes in glucose metabolism after a physical exercise program.(six months)
- Change in the impact of sleep on daily living after a physical activity program(six months)