Polycystic Ovary Syndrome
Conditions
Keywords
Exercise therapy, Reproductive Physiological Processes, Fertility
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.
Interventions
Treadmill running/walking with 10 minutes varm-up at 60-70% of maximum heart rate, 4x4 minute intervals at 90-95% of maximum heart rate separated by 3-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.
Treadmill running/walking with 10 minutes varm-up at 60-70% of maximum heart rate, ten 1-minute intervals at maximal intensity (that can be performed for one minute), separated by 1-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.
Sponsors
St. Olavs Hospital
Liverpool John Moores University
Australian Catholic University
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menstrual frequency | 1 year | Electronic menstrual diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aerobic capacity | 16 weeks, and 36 weeks | Maximal oxygen uptake measured with Oxygon Pro, Jaeger |
| Endothelial function | 16 weeks, and 36 weeks | Flow mediated dilatation of the brachial artery |
| Insulin sensitivity | 16 weeks, and 36 weeks | 2h oral glucose tolerance test (OGGT) |
| Intima-media thickness | 16 weeks, and 36 weeks | Ultrasound of the caroid intima-media thickness |
| Oxidative capacity | 16 weeks, and 36 weeks | carbohydrate- and fat oxidation measured with Oxygon Pro, Jaeger |
| Low-grade systematic inflammation | 16 weeks, and 36 weeks | Blood samples and adipose tissue |
| Adipose tissue morphology and function | 16 weeks, (and 36 weeks if funded) | Adipose tissue biopsy |
| Hormone profile, blood lipids and blood values | 16 weeks, and 36 weeks | Blood samples |
| Body composition | 16 weeks, and 36 weeks | Bioimpedance scale and/or DXA, waist circumference, waist/hip-ratio |
| Quality of life | 16 weeks | PCOS-specific Quality of Life Questionnaire |
| Physical activity | 16 weeks, and 36 weeks | Physical activity monitor armband (amount and intensity) |
| Adipose tissue mRNA expression | 16 weeks, (and 36 weeks if funded) | mRNA analysis of adipose tissue |
| ovarian morphology | 16 weeks, and 36 weeks | vaginal ultrasound |
| Pregnancy rate | 16 weeks , and 36 weeks | In total, between groups, and among those trying to become pregnant when entering the study |
| Enjoyment | weekly up to 16 weeks | Physical Activity Enjoyment Scale (PACES) questionnaire |
| Diet | 16 weeks | Diet diary |
| Blood pressure | 16 weeks, and 36 weeks | Systolic and diastolic measured with automatic blood pressure device |
Countries
Australia, Norway
Outcome results
None listed