Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training

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.

Official Title
-----------------
Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training: A Randomized Controlled Trial.

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Behavioral: 4x4 minutes high intensity interval training
* Behavioral: 10x1 minute high intensity interval training


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4x4 minutes interval training<br>4x4 minutes high intensity interval training with 4 minute intervals | Behavioral: 4x4 minutes high intensity interval training<br>* 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.<br>* Other names: Aerobic exercise;|
| Experimental: 10x1 minute interval training<br>10x1 minute high intensity interval training with 1 minute intervals | Behavioral: 10x1 minute high intensity interval training<br>* 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.<br>* Other names: Aerobic exercise;|
| No Intervention: control<br>Physical activity recommended | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstrual frequency | Electronic menstrual diary | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Bioimpedance scale and/or DXA, waist circumference, waist/hip-ratio | 16 weeks, and 36 weeks | 
| Aerobic capacity | Maximal oxygen uptake measured with Oxygon Pro, Jaeger | 16 weeks, and 36 weeks | 
| Endothelial function | Flow mediated dilatation of the brachial artery | 16 weeks, and 36 weeks | 
| Insulin sensitivity | 2h oral glucose tolerance test (OGGT) | 16 weeks, and 36 weeks | 
| Intima-media thickness | Ultrasound of the caroid intima-media thickness | 16 weeks, and 36 weeks | 
| Oxidative capacity | carbohydrate- and fat oxidation measured with Oxygon Pro, Jaeger | 16 weeks, and 36 weeks | 
| Low-grade systematic inflammation | Blood samples and adipose tissue | 16 weeks, and 36 weeks | 
| Adipose tissue morphology and function | Adipose tissue biopsy | 16 weeks, (and 36 weeks if funded) | 
| Hormone profile, blood lipids and blood values | Blood samples | 16 weeks, and 36 weeks | 
| Blood pressure | Systolic and diastolic measured with automatic blood pressure device | 16 weeks, and 36 weeks | 
| Quality of life | PCOS-specific Quality of Life Questionnaire | 16 weeks | 
| Quality of life | PCOS-specific Quality of Life Questionnaire | 36 weeks | 
| Physical activity | Physical activity monitor armband (amount and intensity) | 16 weeks, and 36 weeks | 
| Adipose tissue mRNA expression | mRNA analysis of adipose tissue | 16 weeks, (and 36 weeks if funded) | 
| ovarian morphology | vaginal ultrasound | 16 weeks, and 36 weeks | 
| Pregnancy rate | In total, between groups, and among those trying to become pregnant when entering the study | 16 weeks , and 36 weeks | 
| Enjoyment | Physical Activity Enjoyment Scale (PACES) questionnaire | weekly up to 16 weeks | 
| Diet | Diet diary | 16 weeks | 
| Diet | Diet diary | 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise therapy, Reproductive Physiological Processes, Fertility