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

Polycystic Ovary Syndrome Clinical Trial

— IMPROV-IT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419482
• Other study ID #: 2015/468
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: April 1, 2020

Study information

• Verified date: August 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC	Melbourne
Norway	Department of circulation and medical imaging , NTNU	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Australian Catholic University, Liverpool John Moores University, St. Olavs Hospital

Countries where clinical trial is conducted

Australia,  Norway, 

References & Publications (1)

Lionett S, Kiel IA, Camera DM, Vanky E, Parr EB, Lydersen S, Hawley JA, Moholdt T. Circulating and Adipose Tissue miRNAs in Women With Polycystic Ovary Syndrome and Responses to High-Intensity Interval Training. Front Physiol. 2020 Jul 30;11:904. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menstrual frequency	Electronic menstrual diary	1 year
Secondary	Body composition	Bioimpedance scale and/or DXA, waist circumference, waist/hip-ratio	16 weeks, and 36 weeks
Secondary	Aerobic capacity	Maximal oxygen uptake measured with Oxygon Pro, Jaeger	16 weeks, and 36 weeks
Secondary	Endothelial function	Flow mediated dilatation of the brachial artery	16 weeks, and 36 weeks
Secondary	Insulin sensitivity	2h oral glucose tolerance test (OGGT)	16 weeks, and 36 weeks
Secondary	Intima-media thickness	Ultrasound of the caroid intima-media thickness	16 weeks, and 36 weeks
Secondary	Oxidative capacity	carbohydrate- and fat oxidation measured with Oxygon Pro, Jaeger	16 weeks, and 36 weeks
Secondary	Low-grade systematic inflammation	Blood samples and adipose tissue	16 weeks, and 36 weeks
Secondary	Adipose tissue morphology and function	Adipose tissue biopsy	16 weeks, (and 36 weeks if funded)
Secondary	Hormone profile, blood lipids and blood values	Blood samples	16 weeks, and 36 weeks
Secondary	Blood pressure	Systolic and diastolic measured with automatic blood pressure device	16 weeks, and 36 weeks
Secondary	Quality of life	PCOS-specific Quality of Life Questionnaire	16 weeks
Secondary	Quality of life	PCOS-specific Quality of Life Questionnaire	36 weeks
Secondary	Physical activity	Physical activity monitor armband (amount and intensity)	16 weeks, and 36 weeks
Secondary	Adipose tissue mRNA expression	mRNA analysis of adipose tissue	16 weeks, (and 36 weeks if funded)
Secondary	ovarian morphology	vaginal ultrasound	16 weeks, and 36 weeks
Secondary	Pregnancy rate	In total, between groups, and among those trying to become pregnant when entering the study	16 weeks , and 36 weeks
Secondary	Enjoyment	Physical Activity Enjoyment Scale (PACES) questionnaire	weekly up to 16 weeks
Secondary	Diet	Diet diary	16 weeks
Secondary	Diet	Diet diary	36 weeks