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Completed

NCT Number: NCT02419482

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC, Melbourne, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4x4 minutes high intensity interval training

Behavioral

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.

Other names: High-intensity exercise, Aerobic exercise

10x1 minute high intensity interval training

Behavioral

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.

Other names: High-intensity exercise, Aerobic exercise

Primary outcomes

  1. Menstrual frequency

    Time frame: 1 year

    Electronic menstrual diary

Secondary outcomes

  1. Body composition

    Time frame: 16 weeks, and 36 weeks

    Bioimpedance scale and/or DXA, waist circumference, waist/hip-ratio

  2. Aerobic capacity

    Time frame: 16 weeks, and 36 weeks

    Maximal oxygen uptake measured with Oxygon Pro, Jaeger

  3. Endothelial function

    Time frame: 16 weeks, and 36 weeks

    Flow mediated dilatation of the brachial artery

  4. Insulin sensitivity

    Time frame: 16 weeks, and 36 weeks

    2h oral glucose tolerance test (OGGT)

  5. Intima-media thickness

    Time frame: 16 weeks, and 36 weeks

    Ultrasound of the caroid intima-media thickness

  6. Oxidative capacity

    Time frame: 16 weeks, and 36 weeks

    carbohydrate- and fat oxidation measured with Oxygon Pro, Jaeger

  7. Low-grade systematic inflammation

    Time frame: 16 weeks, and 36 weeks

    Blood samples and adipose tissue

  8. Adipose tissue morphology and function

    Time frame: 16 weeks, (and 36 weeks if funded)

    Adipose tissue biopsy

  9. Hormone profile, blood lipids and blood values

    Time frame: 16 weeks, and 36 weeks

    Blood samples

  10. Blood pressure

    Time frame: 16 weeks, and 36 weeks

    Systolic and diastolic measured with automatic blood pressure device

  11. Quality of life

    Time frame: 16 weeks

    PCOS-specific Quality of Life Questionnaire

  12. Quality of life

    Time frame: 36 weeks

    PCOS-specific Quality of Life Questionnaire

  13. Physical activity

    Time frame: 16 weeks, and 36 weeks

    Physical activity monitor armband (amount and intensity)

  14. Adipose tissue mRNA expression

    Time frame: 16 weeks, (and 36 weeks if funded)

    mRNA analysis of adipose tissue

  15. ovarian morphology

    Time frame: 16 weeks, and 36 weeks

    vaginal ultrasound

  16. Pregnancy rate

    Time frame: 16 weeks , and 36 weeks

    In total, between groups, and among those trying to become pregnant when entering the study

  17. Enjoyment

    Time frame: weekly up to 16 weeks

    Physical Activity Enjoyment Scale (PACES) questionnaire

  18. Diet

    Time frame: 16 weeks

    Diet diary

  19. Diet

    Time frame: 36 weeks

    Diet diary

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Australian Catholic University
  • Liverpool John Moores University
  • St. Olavs Hospital

Registry information

Official study title

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

Acronym: IMPROV-IT

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 17, 2015
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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