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The Effect of Aerobic Interval Training on Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT01215617
Recruitment Status : Completed
First Posted : October 6, 2010
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Behavioral: Aerobic Interval training Behavioral: Control Not Applicable

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Aerobic Interval Training on Obstructive Sleep Apnea, Cardiovascular and Pulmonary Function in Obese Patients
Actual Study Start Date : October 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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
Behavioral: Aerobic Interval training
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.

Control
Patients will receive standard medical treatment at the University Hospital lung department.
Behavioral: Control
Standard medical treatment




Primary Outcome Measures :
  1. Apnea-hypopnea index change [ Time Frame: Baseline, 3 and 6 months ]
    Measured by Polysomnography


Secondary Outcome Measures :
  1. Sleep quality [ Time Frame: Baseline, 3 and 6 months ]
    Epworth Sleepiness Scale



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215617


Locations
Norway
Norwegian University of Science and Technology
Trondheim, Norway, 7491
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Trine Karlsen, PhD Norwegian University of Science and Technology

Publications of Results:
Karlsen T, Nes BM, Tjønna AE, Engstrøm M, Støylen A, Steinshamn S. High-intensity interval training improves obstructive sleep apnoea. BMJ Open Sport & Exercise Medicine 2(1): http://dx.doi.org/10.1136/bmjsem-2016-000155

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01215617     History of Changes
Other Study ID Numbers: 2010/1539-5
20101539-2 ( Other Identifier: REK )
First Posted: October 6, 2010    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Randomized controlled study
Exercise training
Lung function
Heart function

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases