High Intensity Interval Training or Strength Training in Women With Polycystic Ovary Syndrome

September 28, 2015 updated by: Norwegian University of Science and Technology

High Intensity Interval Training or Strength Training in Women With Polycystic Ovary Syndrome. A Randomized Controlled Trial

The aim is to investigate whether strength training or high intensity interval training is effective in improving insulin sensitivity, cardiovascular outcomes, body composition and reproductive outcomes in women with Polycystic Ovary Syndrome (PCOS).

Few studies have examined the effect of strength training alone on insulin sensitivity, reproductive outcomes and body composition in women with PCOS. Most previous studies on aerobic exercise in PCOS have applied moderate exercise intensity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

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

  • 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

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women
  • Age 18-45 years old
  • PCOS

Exclusion Criteria:

  • Regular high intensity endurance or strength training (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.

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: strength training
The subjects will attend for supervised training three sessions per week for 10 weeks (9-12). The strength training program involves dynamic contraction at intensities of 60 - 70 % of 1 repetition maximum (RM) to improve strength and muscle hypertrophy. Each session will contain 8 exercises on the major muscle groups. Each drill consists of 10-12 repetitions (reps) x 3 sets separated by one minute rest between sets.
Behavioral: strength training
Other Names:
  • resistance training
Experimental: interval training
High intensity interval training (HIT) three times per week. The three weekly supervised HIT sessions will include two 4x4 min interval sessions and one 10x1 min session. The HIT consist of "uphill" treadmill running/walking.
Behavioral: interval training
Other Names:
  • aerobic exercise
  • high-intensity exercise
No Intervention: control
Based on the Norwegian recommendation we will encourage the control group to perform 60 minutes of physical activity at moderate to high intensity on a daily basis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insulin resistance
Time Frame: 10 weeks
measured with the homeostatic model assessment for insulin resistance (HOMA-IR) method
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: 10 weeks
Measured as body fat % on an impedance scale and waist circumference
10 weeks
Maximum oxygen uptake
Time Frame: 10 weeks
Measured during maximum effort exercise test
10 weeks
Endothelial function
Time Frame: 10 weeks
Flow mediated dilatation of the brachial artery.
10 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Menstruation diary
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

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

Sponsor

Norwegian University of Science and Technology

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

July 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

July 17, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (Estimate)

August 8, 2013

Study Record Updates

Last Update Posted (Estimate)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/886

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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