NCT00813852

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

June 15, 2012

Status Verified

June 1, 2012

Enrollment Period

11 months

First QC Date

December 21, 2008

Last Update Submit

June 14, 2012

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apneaskeletal musclemagnetic stimulationmagnetic resonance spectroscopyinflammatory markersexercise

Outcome Measures

Primary Outcomes (1)

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

    4 months

Secondary Outcomes (1)

  • biochemistry markers, magnetic resonance spectroscopy

    4 months

Study Arms (1)

2

EXPERIMENTAL

exercise training, CPAP, and inspiratory muscle strengthening program

Behavioral: exercise training, IMT

Interventions

exercise training, IMTBEHAVIORAL

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.

Also known as: exercise
2

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10051, Taiwan

Location

Related Publications (2)

  • Chien MY, Lee PL, Yu CW, Wei SY, Shih TT. Intramyocellular Lipids, Insulin Resistance, and Functional Performance in Patients with Severe Obstructive Sleep Apnea. Nat Sci Sleep. 2020 Jan 28;12:69-78. doi: 10.2147/NSS.S232554. eCollection 2020.

    PMID: 32095087DERIVED

  • 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.

    PMID: 21706288DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Meng-Yueh Chien, PhD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
National Taiwan University Hospital

Study Record Dates

First Submitted

December 21, 2008

First Posted

December 23, 2008

Study Start

August 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2011

Last Updated

June 15, 2012

Record last verified: 2012-06

Locations

TW(1)