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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Menstrual frequency
Time Frame: 1 year
Electronic menstrual diary
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Norwegian University of Science and Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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