Comparison of Physical Activity Regimens as Treatments for Obstructive Sleep Apnea

Sponsor

University of South Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT00956423

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

21.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Exercise: A Novel Treatment for Obstructive Sleep Apnea

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Laboratory polysomnographic assessment of apnea-hypopnea index [pre- and post-intervention (12 weeks later)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of South Carolina	Columbia	South Carolina	United States	29208
2	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