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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01919281
Other study ID # 2013/886
Secondary ID
Status Completed
Phase N/A
First received July 17, 2013
Last updated September 28, 2015
Start date July 2013
Est. completion date April 2015

Study information

Verified date May 2015
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial Summary

The aim is to investigate whether strength training or high intensity interval training is effective in improving insulin sensitivity, cardiovascular outcomes, body composition and reproductive outcomes in women with Polycystic Ovary Syndrome (PCOS).

Few studies have examined the effect of strength training alone on insulin sensitivity, reproductive outcomes and body composition in women with PCOS. Most previous studies on aerobic exercise in PCOS have applied moderate exercise intensity.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date April 2015
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Women

- Age 18-45 years old

- PCOS

Exclusion Criteria:

- Regular high intensity endurance or strength training (two or more times per week of vigorous exercise).

- Concurrent treatments (insulin sensitizers or drugs known to affect gonadotropin or ovulation, with a wash out period of 1 months prior to inclusion).

- On-going pregnancy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
strength training

interval training


Locations

Country Name City State
Norway Department of circulation and medical imaging , NTNU Trondheim

Sponsors (1)

Lead Sponsor Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Almenning I, Rieber-Mohn A, Lundgren KM, Shetelig Løvvik T, Garnæs KK, Moholdt T. Effects of High Intensity Interval Training and Strength Training on Metabolic, Cardiovascular and Hormonal Outcomes in Women with Polycystic Ovary Syndrome: A Pilot Study. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Menstruation diary up to 6 months No
Primary insulin resistance measured with the homeostatic model assessment for insulin resistance (HOMA-IR) method 10 weeks No
Secondary Body composition Measured as body fat % on an impedance scale and waist circumference 10 weeks No
Secondary Maximum oxygen uptake Measured during maximum effort exercise test 10 weeks No
Secondary Endothelial function Flow mediated dilatation of the brachial artery. 10 weeks No
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