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The Effect of Aerobic Interval Training on Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01215617
First received: October 4, 2010
Last updated: March 28, 2017
Last verified: March 2017
  Purpose
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 Intervention
Obstructive Sleep Apnea Syndrome
Behavioral: Aerobic Interval training
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator
Primary Purpose: Prevention
Official Title: The Effect of Aerobic Interval Training on Obstructive Sleep Apnea, Cardiovascular and Pulmonary Function in Obese Patients

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

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


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


Enrollment: 30
Actual Study Start Date: October 2010
Study Completion Date: October 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
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 )
Study First Received: October 4, 2010
Last Updated: March 28, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on April 28, 2017