NCT02419482CompletedNot Applicable
Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training: A Randomized Controlled Trial.
Norwegian University of Science and Technology2 sites in 2 countries64 target enrollmentStarted: June 1, 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- Menstrual frequency
Study Overview
Brief Summary
The aim is to investigate whether 16 weeks of high intensity interval training, followed by 36 weeks of home-based exercise, will improve menstrual frequency in women with Polycystic Ovary Syndrome (PCOS) compared with a non-exercising control group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
Exclusion Criteria
- •Regular high intensity endurance (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.
- •Breast feeding within 24 weeks
- •Cardiovascular disease or endocrine disorders
Arms & Interventions
4x4 minutes interval training
Experimental
4x4 minutes high intensity interval training with 4 minute intervals
Intervention: 4x4 minutes high intensity interval training (Behavioral)
10x1 minute interval training
Experimental
10x1 minute high intensity interval training with 1 minute intervals
Intervention: 10x1 minute high intensity interval training (Behavioral)
control
No Intervention
Physical activity recommended
Outcomes
Primary Outcomes
Menstrual frequency
Time Frame: 1 year
Electronic menstrual diary
Secondary Outcomes
- Aerobic capacity(16 weeks, and 36 weeks)
- Physical activity(16 weeks, and 36 weeks)
- Hormone profile, blood lipids and blood values(16 weeks, and 36 weeks)
- Body composition(16 weeks, and 36 weeks)
- Endothelial function(16 weeks, and 36 weeks)
- Insulin sensitivity(16 weeks, and 36 weeks)
- Intima-media thickness(16 weeks, and 36 weeks)
- Oxidative capacity(16 weeks, and 36 weeks)
- Low-grade systematic inflammation(16 weeks, and 36 weeks)
- Adipose tissue morphology and function(16 weeks, (and 36 weeks if funded))
- Pregnancy rate(16 weeks , and 36 weeks)
- Blood pressure(16 weeks, and 36 weeks)
- Quality of life(36 weeks)
- Adipose tissue mRNA expression(16 weeks, (and 36 weeks if funded))
- Enjoyment(weekly up to 16 weeks)
- ovarian morphology(16 weeks, and 36 weeks)
- Diet(36 weeks)
- Quality of life(16 weeks)
- Diet(16 weeks)
Investigators
Study Sites (2)
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