NCT01215617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

2.5 years

First QC Date

October 4, 2010

Last Update Submit

March 28, 2017

Conditions

Keywords

Randomized controlled studyExercise trainingLung functionHeart function

Outcome Measures

Primary Outcomes (1)

  • Apnea-hypopnea index change

    Measured by Polysomnography

    Baseline, 3 and 6 months

Secondary Outcomes (1)

  • Sleep quality

    Baseline, 3 and 6 months

Study Arms (2)

Aerobic Interval Training

EXPERIMENTAL

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

Control

OTHER

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

Behavioral: Control

Interventions

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.

Aerobic Interval Training
ControlBEHAVIORAL

Standard medical treatment

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥ 30 kg/M2
  • Apne - hypopnea index (AHI) \> 10
  • No significant comorbidities
  • Abel to exercise

You may not qualify if:

  • Inability to exercise due to musculoskeletal conditions
  • Known ischemic cardiovascular disease
  • Drug abuse
  • Mental illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, 7491, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Trine Karlsen, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2010

First Posted

October 6, 2010

Study Start

October 1, 2010

Primary Completion

April 1, 2013

Study Completion

October 1, 2013

Last Updated

March 29, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations