Comparison of Physical Activity Regimens as Treatments for Obstructive Sleep Apnea

November 22, 2011 updated by: Christopher Kline, University of South Carolina

Exercise: A Novel Treatment for Obstructive Sleep Apnea

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina
      • Columbia, South Carolina, United States, 29209
        • William Jennings Bryan Dorn VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Laboratory polysomnographic assessment of apnea-hypopnea index
Time Frame: pre- and post-intervention (12 weeks later)
pre- and post-intervention (12 weeks later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

August 7, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (Estimate)

August 11, 2009

Study Record Updates

Last Update Posted (Estimate)

November 24, 2011

Last Update Submitted That Met QC Criteria

November 22, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R36CD000695-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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