The Effect of Aerobic Interval Training on Obstructive Sleep Apnea

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Norwegian University of Science and Technology

ClinicalTrials.gov Identifier:

NCT01215617

First received: October 4, 2010

Last updated: April 15, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 4, 2010

Last Updated Date

April 15, 2013

Start Date ^ICMJE

October 2010

Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Apnea-hypopnea index change [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]

Measured by Polysomnography

Original Primary Outcome Measures ^ICMJE

Apnea-hypopnea index [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]

Measured by Polysomnography

Change History

Complete list of historical versions of study NCT01215617 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sleep quality [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]

Epworth Sleepiness Scale

Original Secondary Outcome Measures ^ICMJE

QUALITY OF LIFE [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]

Epworth Sleepiness Scale

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Effect of Aerobic Interval Training on Obstructive Sleep Apnea

Official Title ^ICMJE

The Effect of Aerobic Interval Training on Obstructive Sleep Apnea, Cardiovascular and Pulmonary Function in Obese Patients

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.

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Obstructive Sleep Apnea Syndrome

Intervention ^ICMJE

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.
Behavioral: Control
Standard medical treatment

Study Arm (s)

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

Intervention: Behavioral: Aerobic Interval training
Control
Patients will receive standard medical treatment at the University Hospital lung department.

Intervention: Behavioral: Control

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

October 2013

Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT01215617

Other Study ID Numbers ^ICMJE

2010/1539-5, 20101539-2

Has Data Monitoring Committee

Responsible Party

Norwegian University of Science and Technology

Study Sponsor ^ICMJE

Norwegian University of Science and Technology

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Trine Karlsen, PhD

Norwegian University of Science and Technology

Information Provided By

Norwegian University of Science and Technology

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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