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Comparison of Physical Activity Regimens as Treatments for Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christopher Kline, University of South Carolina
ClinicalTrials.gov Identifier:
NCT00956423
First received: August 7, 2009
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to compare the efficacy of two different physical activity regimens as complementary or alternative treatment options for the treatment of obstructive sleep apnea. A secondary purpose of the study is to examine the effects of these activity regimens on various health consequences of obstructive sleep apnea, including blood pressure, systemic inflammation, and daytime functioning.


Condition Intervention Phase
Obstructive Sleep Apnea
Behavioral: moderate-intensity aerobic and resistance training
Behavioral: low-intensity stretching
Phase 1
Phase 2

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: Exercise: A Novel Treatment for Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Laboratory polysomnographic assessment of apnea-hypopnea index [ Time Frame: pre- and post-intervention (12 weeks later) ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: August 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: moderate-intensity exercise training Behavioral: moderate-intensity aerobic and resistance training
Individuals will complete four days of aerobic exercise of moderate intensity (60% of maximal VO2, approximated from heart rate). Duration of aerobic activity will gradually increase from weeks 1 through 4 until 180 min of aerobic exercise at the prescribed intensity is performed each week. Following aerobic exercise on two days per week, moderate-intensity resistance training will be performed using eight different resistance machines. One set of 8-12 repetitions will be performed during weeks 1-4; from week 5-on, 2 sets of 8-12 repetitions will be performed.
Active Comparator: low-intensity stretching Behavioral: low-intensity stretching
Individuals will perform supervised whole-body flexibility exercises on two days per week. Two sets of each exercise will be performed, with the duration of each stretch gradually increasing from 15 sec to 30 sec. A total of 15-20 stretches, focusing on whole-body flexibility, will be performed.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • moderate-intensity obstructive sleep apnea (AHI >= 15)
  • sedentary status

Exclusion Criteria:

  • current treatment for obstructive sleep apnea (CPAP, oral devices, etc.)
  • significant cardiovascular, pulmonary, or metabolic disease
  • uncontrolled hypertension
  • inability to exercise (e.g., musculoskeletal, neuromuscular, orthopedic problems)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956423

Locations
United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29208
William Jennings Bryan Dorn VA Medical Center
Columbia, South Carolina, United States, 29209
Sponsors and Collaborators
University of South Carolina
Investigators
Principal Investigator: Christopher E Kline, MS University of South Carolina, William Jennings Bryan Dorn VA Medical Center
Study Chair: Shawn D Youngstedt, PhD University of South Carolina, William Jennings Bryan Dorn VA Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christopher Kline, PI, University of South Carolina
ClinicalTrials.gov Identifier: NCT00956423     History of Changes
Other Study ID Numbers: 1R36CD000695-01
Study First Received: August 7, 2009
Last Updated: November 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Carolina:
obstructive sleep apnea
exercise training
aerobic exercise
resistance exercise

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

ClinicalTrials.gov processed this record on November 20, 2014