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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
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.
Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC
Melbourne, Australia
Department of circulation and medical imaging , NTNU
Trondheim, Norway
Menstrual frequency
Electronic menstrual diary
Time frame: 1 year
Body composition
Bioimpedance scale and/or DXA, waist circumference, waist/hip-ratio
Time frame: 16 weeks, and 36 weeks
Aerobic capacity
Maximal oxygen uptake measured with Oxygon Pro, Jaeger
Time frame: 16 weeks, and 36 weeks
Endothelial function
Flow mediated dilatation of the brachial artery
Time frame: 16 weeks, and 36 weeks
Insulin sensitivity
2h oral glucose tolerance test (OGGT)
Time frame: 16 weeks, and 36 weeks
Intima-media thickness
Ultrasound of the caroid intima-media thickness
Time frame: 16 weeks, and 36 weeks
Oxidative capacity
carbohydrate- and fat oxidation measured with Oxygon Pro, Jaeger
Time frame: 16 weeks, and 36 weeks
Low-grade systematic inflammation
Blood samples and adipose tissue
Time frame: 16 weeks, and 36 weeks
Adipose tissue morphology and function
Adipose tissue biopsy
Time frame: 16 weeks, (and 36 weeks if funded)
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Hormone profile, blood lipids and blood values
Blood samples
Time frame: 16 weeks, and 36 weeks
Blood pressure
Systolic and diastolic measured with automatic blood pressure device
Time frame: 16 weeks, and 36 weeks
Quality of life
PCOS-specific Quality of Life Questionnaire
Time frame: 16 weeks
Quality of life
PCOS-specific Quality of Life Questionnaire
Time frame: 36 weeks
Physical activity
Physical activity monitor armband (amount and intensity)
Time frame: 16 weeks, and 36 weeks
Adipose tissue mRNA expression
mRNA analysis of adipose tissue
Time frame: 16 weeks, (and 36 weeks if funded)
ovarian morphology
vaginal ultrasound
Time frame: 16 weeks, and 36 weeks
Pregnancy rate
In total, between groups, and among those trying to become pregnant when entering the study
Time frame: 16 weeks , and 36 weeks
Enjoyment
Physical Activity Enjoyment Scale (PACES) questionnaire
Time frame: weekly up to 16 weeks
Diet
Diet diary
Time frame: 16 weeks
Diet
Diet diary
Time frame: 36 weeks