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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01215617
Other study ID # 2010/1539-5
Secondary ID 20101539-2
Status Completed
Phase N/A
First received October 4, 2010
Last updated March 28, 2017
Start date October 2010
Est. completion date October 2013

Study information

Verified date March 2017
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

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
Standard medical treatment

Locations

Country Name City State
Norway Norwegian University of Science and Technology Trondheim

Sponsors (1)

Lead Sponsor Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary Apnea-hypopnea index change Measured by Polysomnography Baseline, 3 and 6 months
Secondary Sleep quality Epworth Sleepiness Scale Baseline, 3 and 6 months
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