search
Back to results

Comparison of Physical Activity Regimens as Treatments for Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
moderate-intensity aerobic and resistance training
low-intensity stretching
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, exercise training, aerobic exercise, resistance exercise

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

moderate-intensity exercise training

low-intensity stretching

Arm Description

Outcomes

Primary Outcome Measures

Laboratory polysomnographic assessment of apnea-hypopnea index

Secondary Outcome Measures

Full Information

First Posted
August 7, 2009
Last Updated
November 22, 2011
Sponsor
University of South Carolina
search

1. Study Identification

Unique Protocol Identification Number
NCT00956423
Brief Title
Comparison of Physical Activity Regimens as Treatments for Obstructive Sleep Apnea
Official Title
Exercise: A Novel Treatment for Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, exercise training, aerobic exercise, resistance exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
moderate-intensity exercise training
Arm Type
Experimental
Arm Title
low-intensity stretching
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
moderate-intensity aerobic and resistance training
Intervention Description
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
Intervention Name(s)
low-intensity stretching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Laboratory polysomnographic assessment of apnea-hypopnea index
Time Frame
pre- and post-intervention (12 weeks later)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher E Kline, MS
Organizational Affiliation
University of South Carolina, William Jennings Bryan Dorn VA Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shawn D Youngstedt, PhD
Organizational Affiliation
University of South Carolina, William Jennings Bryan Dorn VA Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
Facility Name
William Jennings Bryan Dorn VA Medical Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11382910
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.
Results Reference
background
PubMed Identifier
11894204
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.
Results Reference
background
PubMed Identifier
19480231
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.
Results Reference
background
PubMed Identifier
17221274
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.
Results Reference
background
PubMed Identifier
15164902
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.
Results Reference
background
PubMed Identifier
22893765
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.
Results Reference
derived
PubMed Identifier
22572632
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.
Results Reference
derived
PubMed Identifier
22131599
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.
Results Reference
derived

Learn more about this trial

Comparison of Physical Activity Regimens as Treatments for Obstructive Sleep Apnea

We'll reach out to this number within 24 hrs