Obstructive Sleep ApneaPhase 1/2NCT00956423
Comparison of Physical Activity Regimens as Treatments for Obstructive Sleep Apnea
A Phase 1/2 study testing moderate-intensity aerobic and resistance training and low-intensity stretching in people with Obstructive Sleep Apnea, run by University of South Carolina at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- moderate-intensity aerobic and resistance training and low-intensity stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to Oct 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- moderate-intensity obstructive sleep apnea (AHI >= 15)
- sedentary status
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of South Carolina
Columbia, South Carolina, 29208
William Jennings Bryan Dorn VA Medical Center
Columbia, South Carolina, 29209
About this study
Official title: Exercise: A Novel Treatment for Obstructive Sleep Apnea
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- moderate-intensity aerobic and resistance training, low-intensity stretching
- Keywords
- obstructive sleep apnea, exercise training, aerobic exercise, resistance exercise
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate-intensity aerobic and resistance trainingBehavioural
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 stretchingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| moderate-intensity exercise training | Experimental | Not described Receives: Behavioral: moderate-intensity aerobic and resistance training |
| low-intensity stretching | Active comparator | Not described Receives: Behavioral: low-intensity stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory polysomnographic assessment of apnea-hypopnea index
Measured: pre- and post-intervention (12 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Kline, University of South Carolina
- Investigators
- Christopher E Kline, MS, Principal investigator, University of South Carolina, William Jennings Bryan Dorn VA Medical CenterShawn D Youngstedt, PhD, Study chair, University of South Carolina, William Jennings Bryan Dorn VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956423
- Sponsor's protocol ID
- 1R36CD000695-01
- Status last verified
- Nov 2011
- First submitted
- 7 Aug 2009
- Last updated
- 24 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11382910Giebelhaus 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.
PubMed 11894204Ueno 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.
PubMed 19480231Quan 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.
PubMed 17221274Peppard 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.
PubMed 15164902Kline 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.
PubMed 22893765Kline 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.
PubMed 22572632Kline 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.
PubMed 22131599
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise: A Novel Treatment for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00956423
- Acronym / sponsor ID
- 1R36CD000695-01
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, exercise training, aerobic exercise, resistance exercise
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moderate-intensity exercise training | Experimental | Behavioral: moderate-intensity aerobic and resistance training |
| low-intensity stretching | Active comparator | Behavioral: low-intensity stretching |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- moderate-intensity obstructive sleep apnea (AHI >= 15)
- sedentary status
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| moderate-intensity aerobic and resistance trainingIndividuals 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. | Behavioural | moderate-intensity exercise training |
| low-intensity stretchingIndividuals 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. | Behavioural | low-intensity stretching |
Primary outcome
Laboratory polysomnographic assessment of apnea-hypopnea index
Time frame: pre- and post-intervention (12 weeks later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2011.
- Background: PubMed 11382910Norman JF, Von Essen SG, Fuchs RH, McElligott M. Exercise training effect on obstructive sleep apnea syndrome. Sleep Res Online. 2000;3(3):121-9.
- Background: PubMed 11894204Giebelhaus 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.
- Background: PubMed 19480231Ueno 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.
- Background: PubMed 17221274Quan 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.
- Background: PubMed 15164902Peppard 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.
- Derived from this study: PubMed 22893765Kline 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.
- Derived from this study: PubMed 22572632Kline 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.
- Derived from this study: PubMed 22131599Kline 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher E Kline, MS principal investigator
University of South Carolina, William Jennings Bryan Dorn VA Medical Center
Shawn D Youngstedt, PhD study chair
University of South Carolina, William Jennings Bryan Dorn VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing moderate-intensity aerobic and resistance training and low-intensity stretching in people with Obstructive Sleep Apnea, run by University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory polysomnographic assessment of apnea-hypopnea index (time frame: pre- and post-intervention (12 weeks later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00956423, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2011.