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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Behavioral: 4x4 minutes high intensity interval training; Behavioral: 10x1 minute high intensity interval training

• Registration Number: NCT02419482
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-17
• Study Start: 2015-06
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4x4 minutes interval training	4x4 minutes high intensity interval training	4x4 minutes high intensity interval training with 4 minute intervals
10x1 minute interval training	10x1 minute high intensity interval training	10x1 minute high intensity interval training with 1 minute intervals

Primary Outcome Measures

Name	Time	Method
Menstrual frequency	1 year	Electronic menstrual diary

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Department of circulation and medical imaging , NTNU; 🇳🇴 Trondheim, Norway

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