Clinical trial NCT00956423: Comparison of Physical Activity Regimens as Treatments for Obstructive Sleep Apnea
Official title: Exercise: A Novel Treatment for Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
exercise training
aerobic exercise
resistance exercise
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Laboratory polysomnographic assessment of apnea-hypopnea index
timeFrame: pre- and post-intervention (12 weeks later)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: William Jennings Bryan Dorn VA Medical Center
state: South Carolina
Study officials:
affiliation: University of South Carolina, William Jennings Bryan Dorn VA Medical Center
name: Christopher E Kline, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Carolina, William Jennings Bryan Dorn VA Medical Center
name: Shawn D Youngstedt, PhD
role: STUDY_CHAIR
References:
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.
citation: 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. doi: 10.1007/s11325-000-0173-z.
citation: Ueno LM, Drager LF, Rodrigues AC, Rondon MU, Braga AM, Mathias W Jr, Krieger EM, Barretto AC, Middlekauff HR, Lorenzi-Filho G, Negrao CE. Effects of exercise training in patients with chronic heart failure and sleep apnea. Sleep. 2009 May;32(5):637-47. doi: 10.1093/sleep/32.5.637.
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. doi: 10.1007/s11325-006-0095-5.
citation: Peppard PE, Young T. Exercise and sleep-disordered breathing: an association independent of body habitus. Sleep. 2004 May 1;27(3):480-4. doi: 10.1093/sleep/27.3.480.
citation: Kline CE, Ewing GB, Burch JB, Blair SN, Durstine JL, Davis JM, Youngstedt SD. Exercise training improves selected aspects of daytime functioning in adults with obstructive sleep apnea. J Clin Sleep Med. 2012 Aug 15;8(4):357-65. doi: 10.5664/jcsm.2022.
citation: Kline CE, Crowley EP, Ewing GB, Burch JB, Blair SN, Durstine JL, Davis JM, Youngstedt SD. Blunted heart rate recovery is improved following exercise training in overweight adults with obstructive sleep apnea. Int J Cardiol. 2013 Aug 20;167(4):1610-5. doi: 10.1016/j.ijcard.2012.04.108. Epub 2012 May 8.
citation: Kline CE, Crowley EP, Ewing GB, Burch JB, Blair SN, Durstine JL, Davis JM, Youngstedt SD. The effect of exercise training on obstructive sleep apnea and sleep quality: a randomized controlled trial. Sleep. 2011 Dec 1;34(12):1631-40. doi: 10.5665/sleep.1422.