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临床试验/NCT00813852
NCT00813852已完成不适用

The Study of Skeletal Muscle Function in Obstructive Sleep Apnea

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2007年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
129
试验地点
1
主要终点
strength, endurance, fatigability, and nerve conduction velocity in response to magnetic stimulation

研究概览

简要总结

The purposes of this study includes (1)to investigate inspiratory muscles and non-inspiratory muscle function in terms of strength, endurance, and fatigability in patients with obstructive sleep apnea (OSA), (2) investigate the metabolic characteristics of peripheral muscles and biochemistry markers in patients with OSA, and (3) to detect the effect of exercise training on the measured parameters in patients with OSA.

详细描述

It has become increasingly recognized that skeletal muscle abnormalities are common and profound in patients with chronic inflammatory status. Based on the unique character of obstructive sleep apnea (OSA), repeated intermittent apnea and hypopnea caused by the upper airway muscles collapse during inspiration, it is logical to speculate some adaptations in skeletal muscle of patients with OSA. The purpose of the first part is to investigate the inspiratory muscle function in patients with different severity of OSA. Participants firstly underwent polysomnography assessments will be recruited. The measurements includes Epworth sleepiness scale, strength and endurance of inspiratory muscles, and fatigue test during either maximal voluntary efforts or in response to cervical magnetic stimulation (CMS) with simultaneously sEMG recordings. In addition, the exercise capacity with simultaneous sEMG recordings for diaphragm and vastus lateralis during the exercise testing will also be tested. The second part is designed to examine the metabolic characteristics of lower extremity in patients with OSA. Blood samples will be drawn and proton magnetic resonance spectroscopy is used to detect intramyocellular and extramyocellular lipid contents (IMCL and EMCL). The third part will detect the effect of exercise training on the measured parameters described as above in patients with OSA. Participants will be randomized into exercise group, inspiratory muscle training group (IMT), and CPAP group. Exercise protocol includes 30-minute aerobic exercise at the intensity of 70%-85% VO2max, and 20-minute general resistance exercise. IMT group will receive inspiratory muscle strengthening by device.

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
40 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •ages from 40-65 years men who first underwent polysomnography at the Sleep Research Center.

排除标准

  • •Subjects who had active medical or nervous system diseases, abnormal pulmonary function, morbid obesity, diabetes managed with oral hypoglycemic agents, alcoholism (≥ 50 gm per day), or a recent infection.

研究组 & 干预措施

2

Experimental

exercise training, CPAP, and inspiratory muscle strengthening program

干预措施: exercise training, IMT (Behavioral)

结局指标

主要结局

strength, endurance, fatigability, and nerve conduction velocity in response to magnetic stimulation

时间窗: 4 months

次要结局

  • biochemistry markers, magnetic resonance spectroscopy(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

National Taiwan University Hospital

National Taiwan University Hospital

National Taiwan University Hospital

研究点 (1)

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