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
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Behavioral: exercise training, IMT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Study of Skeletal Muscle Function in Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • strength, endurance, fatigability, and nerve conduction velocity in response to magnetic stimulation [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • biochemistry markers, magnetic resonance spectroscopy [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: August 2007
Study Completion Date: July 2011
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
exercise training, CPAP, and inspiratory muscle strengthening program
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813852

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10051
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Meng-Yueh Chien, PhD National Taiwan University
  More Information

No publications provided by National Taiwan University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00813852     History of Changes
Other Study ID Numbers: 200612106R
Study First Received: December 21, 2008
Last Updated: June 14, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
obstructive sleep apnea
skeletal muscle
magnetic stimulation
magnetic resonance spectroscopy
inflammatory markers
exercise

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 23, 2014