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The Effect of Aerobic Interval Training on Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Aerobic Interval training
Control
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obstructive Sleep Apnea Syndrome focused on measuring Randomized controlled study, Exercise training, Lung function, Heart function

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Norwegian University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Aerobic Interval Training

Control

Arm Description

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

Patients will receive standard medical treatment at the University Hospital lung department.

Outcomes

Primary Outcome Measures

Apnea-hypopnea index change
Measured by Polysomnography

Secondary Outcome Measures

Sleep quality
Epworth Sleepiness Scale

Full Information

First Posted
October 4, 2010
Last Updated
March 28, 2017
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01215617
Brief Title
The Effect of Aerobic Interval Training on Obstructive Sleep Apnea
Official Title
The Effect of Aerobic Interval Training on Obstructive Sleep Apnea, Cardiovascular and Pulmonary Function in Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2010 (Actual)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
Randomized controlled study, Exercise training, Lung function, Heart function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Interval Training
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Other
Arm Description
Patients will receive standard medical treatment at the University Hospital lung department.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Interval training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Standard medical treatment
Primary Outcome Measure Information:
Title
Apnea-hypopnea index change
Description
Measured by Polysomnography
Time Frame
Baseline, 3 and 6 months
Secondary Outcome Measure Information:
Title
Sleep quality
Description
Epworth Sleepiness Scale
Time Frame
Baseline, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trine Karlsen, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian University of Science and Technology
City
Trondheim
ZIP/Postal Code
7491
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29616142
Citation
Karlsen T, Nes BM, Tjonna AE, Engstrom M, Stoylen A, Steinshamn S. High-intensity interval training improves obstructive sleep apnoea. BMJ Open Sport Exerc Med. 2017 Feb 8;2(1):bmjsem-2016-000155. doi: 10.1136/bmjsem-2016-000155. eCollection 2016.
Results Reference
result

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The Effect of Aerobic Interval Training on Obstructive Sleep Apnea

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