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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 7, 2009

Last Updated Date

November 22, 2011

Start Date ^ICMJE

August 2009

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00956423 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of Physical Activity Regimens as Treatments for Obstructive Sleep Apnea

Official Title ^ICMJE

Exercise: A Novel Treatment for Obstructive Sleep Apnea

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Obstructive Sleep Apnea

Intervention ^ICMJE

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.
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.

Study Arm (s)

Experimental: moderate-intensity exercise training
Intervention: Behavioral: moderate-intensity aerobic and resistance training
Active Comparator: low-intensity stretching
Intervention: Behavioral: low-intensity stretching

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00956423

Other Study ID Numbers ^ICMJE

1R36CD000695-01

Has Data Monitoring Committee

Responsible Party

Christopher Kline, University of South Carolina

Study Sponsor ^ICMJE

University of South Carolina

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

University of South Carolina

Verification Date

November 2011

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

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