NCT00956423

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2009

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 24, 2011

Status Verified

November 1, 2011

Enrollment Period

2.2 years

First QC Date

August 7, 2009

Last Update Submit

November 22, 2011

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apneaexercise trainingaerobic exerciseresistance exercise

Outcome Measures

Primary Outcomes (1)

  • Laboratory polysomnographic assessment of apnea-hypopnea index

    pre- and post-intervention (12 weeks later)

Study Arms (2)

moderate-intensity exercise training

EXPERIMENTAL
Behavioral: moderate-intensity aerobic and resistance training

low-intensity stretching

ACTIVE COMPARATOR
Behavioral: low-intensity stretching

Interventions

moderate-intensity aerobic and resistance trainingBEHAVIORAL

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.

moderate-intensity exercise training
low-intensity stretchingBEHAVIORAL

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.

low-intensity stretching

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • moderate-intensity obstructive sleep apnea (AHI \>= 15)
  • sedentary status

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

William Jennings Bryan Dorn VA Medical Center

Columbia, South Carolina, 29209, United States

Location

Related Publications (8)

  • 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.

    PMID: 11382910BACKGROUND

  • 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.

    PMID: 11894204BACKGROUND

  • 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.

    PMID: 19480231BACKGROUND

  • 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.

    PMID: 17221274BACKGROUND

  • 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.

    PMID: 15164902BACKGROUND

  • 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.

    PMID: 22893765DERIVED

  • 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.

    PMID: 22572632DERIVED

  • 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.

    PMID: 22131599DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Christopher E Kline, MS

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

    PRINCIPAL INVESTIGATOR

  • Shawn D Youngstedt, PhD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

August 7, 2009

First Posted

August 11, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 24, 2011

Record last verified: 2011-11

Locations

US(2)