Comparison of Physical Activity Regimens as Treatments for Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Exercise: A Novel Treatment for Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956423
• Other study ID #: 1R36CD000695-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 7, 2009
• Last updated: November 22, 2011
• Start date: August 2009
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina
United States	William Jennings Bryan Dorn VA Medical Center	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (5)

Giebelhaus V, Strohl KP, Lormes W, Lehmann M, Netzer N. Physical Exercise as an Adjunct Therapy in Sleep Apnea-An Open Trial. Sleep Breath. 2000;4(4):173-176. — View Citation

Norman JF, Von Essen SG, Fuchs RH, McElligott M. Exercise training effect on obstructive sleep apnea syndrome. Sleep Res Online. 2000;3(3):121-9. — View Citation

Peppard PE, Young T. Exercise and sleep-disordered breathing: an association independent of body habitus. Sleep. 2004 May 1;27(3):480-4. — View Citation

Quan SF, O'Connor GT, Quan JS, Redline S, Resnick HE, Shahar E, Siscovick D, Sherrill DL. Association of physical activity with sleep-disordered breathing. Sleep Breath. 2007 Sep;11(3):149-57. — View Citation

Ueno LM, Drager LF, Rodrigues AC, Rondon MU, Braga AM, Mathias W Jr, Krieger EM, Barretto AC, Middlekauff HR, Lorenzi-Filho G, Negrão CE. Effects of exercise training in patients with chronic heart failure and sleep apnea. Sleep. 2009 May;32(5):637-47. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory polysomnographic assessment of apnea-hypopnea index		pre- and post-intervention (12 weeks later)	No