Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training (IMPROV-IT)
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ClinicalTrials.gov Identifier: NCT02419482 |
Recruitment Status :
Completed
First Posted : April 17, 2015
Last Update Posted : September 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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Polycystic Ovary Syndrome | Behavioral: 4x4 minutes high intensity interval training Behavioral: 10x1 minute high intensity interval training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training: A Randomized Controlled Trial. |
Actual Study Start Date : | June 2015 |
Actual Primary Completion Date : | April 1, 2020 |
Actual Study Completion Date : | April 1, 2020 |

Arm | Intervention/treatment |
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Experimental: 4x4 minutes interval training
4x4 minutes high intensity interval training with 4 minute intervals
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Behavioral: 4x4 minutes high intensity interval training
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:
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Experimental: 10x1 minute interval training
10x1 minute high intensity interval training with 1 minute intervals
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Behavioral: 10x1 minute high intensity interval training
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:
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No Intervention: control
Physical activity recommended
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- Menstrual frequency [ Time Frame: 1 year ]Electronic menstrual diary
- Body composition [ Time Frame: 16 weeks, and 36 weeks ]Bioimpedance scale and/or DXA, waist circumference, waist/hip-ratio
- Aerobic capacity [ Time Frame: 16 weeks, and 36 weeks ]Maximal oxygen uptake measured with Oxygon Pro, Jaeger
- Endothelial function [ Time Frame: 16 weeks, and 36 weeks ]Flow mediated dilatation of the brachial artery
- Insulin sensitivity [ Time Frame: 16 weeks, and 36 weeks ]2h oral glucose tolerance test (OGGT)
- Intima-media thickness [ Time Frame: 16 weeks, and 36 weeks ]Ultrasound of the caroid intima-media thickness
- Oxidative capacity [ Time Frame: 16 weeks, and 36 weeks ]carbohydrate- and fat oxidation measured with Oxygon Pro, Jaeger
- Low-grade systematic inflammation [ Time Frame: 16 weeks, and 36 weeks ]Blood samples and adipose tissue
- Adipose tissue morphology and function [ Time Frame: 16 weeks, (and 36 weeks if funded) ]Adipose tissue biopsy
- Hormone profile, blood lipids and blood values [ Time Frame: 16 weeks, and 36 weeks ]Blood samples
- Blood pressure [ Time Frame: 16 weeks, and 36 weeks ]Systolic and diastolic measured with automatic blood pressure device
- Quality of life [ Time Frame: 16 weeks ]PCOS-specific Quality of Life Questionnaire
- Quality of life [ Time Frame: 36 weeks ]PCOS-specific Quality of Life Questionnaire
- Physical activity [ Time Frame: 16 weeks, and 36 weeks ]Physical activity monitor armband (amount and intensity)
- Adipose tissue mRNA expression [ Time Frame: 16 weeks, (and 36 weeks if funded) ]mRNA analysis of adipose tissue
- ovarian morphology [ Time Frame: 16 weeks, and 36 weeks ]vaginal ultrasound
- Pregnancy rate [ Time Frame: 16 weeks , and 36 weeks ]In total, between groups, and among those trying to become pregnant when entering the study
- Enjoyment [ Time Frame: weekly up to 16 weeks ]Physical Activity Enjoyment Scale (PACES) questionnaire
- Diet [ Time Frame: 16 weeks ]Diet diary
- Diet [ Time Frame: 36 weeks ]Diet diary

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02419482
Australia | |
Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC | |
Melbourne, Australia | |
Norway | |
Department of circulation and medical imaging , NTNU | |
Trondheim, Norway, 7491 |
Principal Investigator: | Trine Moholdt, phd | Norwegian University of Science and Technology |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Norwegian University of Science and Technology |
ClinicalTrials.gov Identifier: | NCT02419482 |
Other Study ID Numbers: |
2015/468 |
First Posted: | April 17, 2015 Key Record Dates |
Last Update Posted: | September 2, 2020 |
Last Verified: | August 2020 |
Exercise therapy Reproductive Physiological Processes Fertility |
Polycystic Ovary Syndrome Syndrome Disease Pathologic Processes Ovarian Cysts Cysts |
Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases |