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OpenTrials
Completed

NCT Number: NCT01919281

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Behavior Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of circulation and medical imaging , NTNU

Trondheim, 7491, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

strength training

Behavioral

Other names: resistance training

Interval Training

Behavioral

Other names: high-intensity exercise, aerobic exercise

Primary outcomes

  1. insulin resistance

    Time frame: 10 weeks

    measured with the homeostatic model assessment for insulin resistance (HOMA-IR) method

Secondary outcomes

  1. Body composition

    Time frame: 10 weeks

    Measured as body fat % on an impedance scale and waist circumference

  2. Maximum oxygen uptake

    Time frame: 10 weeks

    Measured during maximum effort exercise test

  3. Endothelial function

    Time frame: 10 weeks

    Flow mediated dilatation of the brachial artery.

Other outcomes

  1. Menstruation diary

    Time frame: up to 6 months

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Aug 8, 2013
Registry last updated
Sep 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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