The Study of Skeletal Muscle Function in Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00813852
First received: December 21, 2008
Last updated: June 14, 2012
Last verified: June 2012

December 21, 2008
June 14, 2012
August 2007
July 2008   (final data collection date for primary outcome measure)
strength, endurance, fatigability, and nerve conduction velocity in response to magnetic stimulation [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00813852 on ClinicalTrials.gov Archive Site
biochemistry markers, magnetic resonance spectroscopy [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Study of Skeletal Muscle Function in Obstructive Sleep Apnea
The Study of Skeletal Muscle Function in Obstructive Sleep Apnea

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Obstructive Sleep Apnea
Behavioral: exercise training, IMT
Each exercise session includes graded treadmill walking and resisted exercises. The graded treadmill walking exercise begins with a 5 minute warm-up period with the intensity of about 40% of maximal oxygen consumption (VO2max) follows by a 30 minutes training phase. The training intensity is set at about 70%-85% of VO2max and ends with a 5-minute cool-down period with the intensity of about 40% of VO2max. The resisted exercise program includes 20 minutes of weight training with rest after the first 5 minutes.
Other Name: exercise
Experimental: 2
exercise training, CPAP, and inspiratory muscle strengthening program
Intervention: Behavioral: exercise training, IMT
Chien MY, Lee P, Tsai YF, Yang PC, Wu YT. C-reactive protein and heart rate recovery in middle-aged men with severe obstructive sleep apnea. Sleep Breath. 2012 Sep;16(3):629-37. doi: 10.1007/s11325-011-0549-2. Epub 2011 Jun 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
July 2011
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
Male
40 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00813852
200612106R
No
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Meng-Yueh Chien, PhD National Taiwan University
National Taiwan University Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP