Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training (IMPROV-IT)

August 31, 2020 updated by: Norwegian University of Science and Technology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia
        • Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC
  • Norway
      • Trondheim, Norway, 7491
        • Department of circulation and medical imaging , NTNU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4x4 minutes interval training
4x4 minutes high intensity interval training with 4 minute intervals
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:
  • High-intensity exercise
  • Aerobic exercise
Experimental: 10x1 minute interval training
10x1 minute high intensity interval training with 1 minute intervals
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:
  • High-intensity exercise
  • Aerobic exercise
No Intervention: control
Physical activity recommended

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital
Liverpool John Moores University
Australian Catholic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

April 14, 2015

First Submitted That Met QC Criteria

April 16, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/468

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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