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

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ClinicalTrials.gov Identifier: NCT01919281
Recruitment Status : Completed
First Posted : August 8, 2013
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Behavioral: strength training Behavioral: interval training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Intensity Interval Training or Strength Training in Women With Polycystic Ovary Syndrome. A Randomized Controlled Trial
Study Start Date : July 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


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 Name: 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:
  • high-intensity exercise
  • aerobic 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.



Primary Outcome Measures :
  1. insulin resistance [ Time Frame: 10 weeks ]
    measured with the homeostatic model assessment for insulin resistance (HOMA-IR) method


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Menstruation diary [ Time Frame: up to 6 months ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919281


Locations
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Norway
Department of circulation and medical imaging , NTNU
Trondheim, Norway, 7491
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
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Principal Investigator: Trine Moholdt, phd Norwegian University of Science and Technology

Publications of Results:
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01919281     History of Changes
Other Study ID Numbers: 2013/886
First Posted: August 8, 2013    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: May 2015
Keywords provided by Norwegian University of Science and Technology:
exercise
resistance training
insulin resistance
high intensity interval training
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases