The Effect of Aerobic Interval Training on Obstructive Sleep Apnea
March 28, 2017 updated by: Norwegian University of Science and Technology
The Effect of Aerobic Interval Training on Obstructive Sleep Apnea, Cardiovascular and Pulmonary Function in Obese Patients
The purpose of this study is to investigate if 3 months of interval training improves obstructive sleep apnea in obese patients diagnosed with moderate to severe obstructive sleep apnea.
The working hypothesis is that 3 months of 3 weekly aerobic interval training sessions improve obstructive sleep apnea and sleep quality in obese patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Obstructive sleep apnea syndrome (OSAS) is characterized by repetitive obstruction and collapse of the upper airway resulting in successive episodes of cessation of or decreased respiratory airflow, causing oxygen desaturation, awakening, loud snoring and daytime sleepiness in patients.
Sleep apnea is frequently associated with co-morbidity such as obesity, diabetes, hypertension, the metabolic syndrome and cardiovascular disease.
Lack of exercise is associated with OSAS severity, independent of body mass.
Participation and motivation to exercise is low in OSAS patients, with less that one third of the patients reporting regular exercise routines.
We aim to investigate if aerobic interval training improves OSAS in obese subjects.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Trondheim, Norway, 7491
- Norwegian University of Science and Technology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI ≥ 30 kg/M2
- Apne - hypopnea index (AHI) > 10
- No significant comorbidities
- Abel to exercise
Exclusion Criteria:
- Inability to exercise due to musculoskeletal conditions
- Known ischemic cardiovascular disease
- Drug abuse
- Mental illnesses
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Aerobic Interval Training
Patients randomized to training will meet for supervised aerobic interval training three times per week for 3 months.
The interval training session consists of 10 minutes warm up and continues with 4 x 4 minutes of high intensity intervals at 90-95% of maximal heart rate
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Treadmill walking or running - 3 times per week for 3 months.
The interval training session consists of 10 minutes warm up and continues with 4 x 4 minutes high intensity intervals at 90-95% of maximal heart rate.
Training intensity will be supervised through the use of Polar pulse monitors and the BORG scale of subjective perceived exhaustion.
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Other: Control
Patients will receive standard medical treatment at the University Hospital lung department.
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Standard medical treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Apnea-hypopnea index change
Time Frame: Baseline, 3 and 6 months
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Measured by Polysomnography
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Baseline, 3 and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep quality
Time Frame: Baseline, 3 and 6 months
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Epworth Sleepiness Scale
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Baseline, 3 and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2010
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
October 4, 2010
First Submitted That Met QC Criteria
October 5, 2010
First Posted (Estimate)
October 6, 2010
Study Record Updates
Last Update Posted (Actual)
March 29, 2017
Last Update Submitted That Met QC Criteria
March 28, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010/1539-5
- 20101539-2 (Other Identifier: REK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.