Comparison of Physical Activity Regimens as Treatments for Obstructive Sleep Apnea

NCT ID: NCT00956423

Last Updated: 2011-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-10-31

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea

Keywords

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obstructive sleep apnea exercise training aerobic exercise resistance exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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moderate-intensity exercise training

Group Type EXPERIMENTAL

moderate-intensity aerobic and resistance training

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

low-intensity stretching

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Christopher Kline

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher E Kline, MS

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina, William Jennings Bryan Dorn VA Medical Center

Shawn D Youngstedt, PhD

Role: STUDY_CHAIR

University of South Carolina, William Jennings Bryan Dorn VA Medical Center

Locations

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University of South Carolina

Columbia, South Carolina, United States

Site Status

William Jennings Bryan Dorn VA Medical Center

Columbia, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 11382910 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11894204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19480231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17221274 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15164902 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22893765 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22572632 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22131599 (View on PubMed)

Other Identifiers

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1R36CD000695-01

Identifier Type: NIH

Identifier Source: org_study_id

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