Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02419482
Recruitment Status : Completed
First Posted : April 17, 2015
Last Update Posted : September 2, 2020
Sponsor:
Collaborators:
St. Olavs Hospital
Liverpool John Moores University
Australian Catholic University
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Behavioral: 4x4 minutes high intensity interval training Behavioral: 10x1 minute high intensity interval training Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training: A Randomized Controlled Trial.
Actual Study Start Date : June 2015
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Menstrual frequency [ Time Frame: 1 year ]
    Electronic menstrual diary


Secondary Outcome Measures :
  1. Body composition [ Time Frame: 16 weeks, and 36 weeks ]
    Bioimpedance scale and/or DXA, waist circumference, waist/hip-ratio

  2. Aerobic capacity [ Time Frame: 16 weeks, and 36 weeks ]
    Maximal oxygen uptake measured with Oxygon Pro, Jaeger

  3. Endothelial function [ Time Frame: 16 weeks, and 36 weeks ]
    Flow mediated dilatation of the brachial artery

  4. Insulin sensitivity [ Time Frame: 16 weeks, and 36 weeks ]
    2h oral glucose tolerance test (OGGT)

  5. Intima-media thickness [ Time Frame: 16 weeks, and 36 weeks ]
    Ultrasound of the caroid intima-media thickness

  6. Oxidative capacity [ Time Frame: 16 weeks, and 36 weeks ]
    carbohydrate- and fat oxidation measured with Oxygon Pro, Jaeger

  7. Low-grade systematic inflammation [ Time Frame: 16 weeks, and 36 weeks ]
    Blood samples and adipose tissue

  8. Adipose tissue morphology and function [ Time Frame: 16 weeks, (and 36 weeks if funded) ]
    Adipose tissue biopsy

  9. Hormone profile, blood lipids and blood values [ Time Frame: 16 weeks, and 36 weeks ]
    Blood samples

  10. Blood pressure [ Time Frame: 16 weeks, and 36 weeks ]
    Systolic and diastolic measured with automatic blood pressure device

  11. Quality of life [ Time Frame: 16 weeks ]
    PCOS-specific Quality of Life Questionnaire

  12. Quality of life [ Time Frame: 36 weeks ]
    PCOS-specific Quality of Life Questionnaire

  13. Physical activity [ Time Frame: 16 weeks, and 36 weeks ]
    Physical activity monitor armband (amount and intensity)

  14. Adipose tissue mRNA expression [ Time Frame: 16 weeks, (and 36 weeks if funded) ]
    mRNA analysis of adipose tissue

  15. ovarian morphology [ Time Frame: 16 weeks, and 36 weeks ]
    vaginal ultrasound

  16. Pregnancy rate [ Time Frame: 16 weeks , and 36 weeks ]
    In total, between groups, and among those trying to become pregnant when entering the study

  17. Enjoyment [ Time Frame: weekly up to 16 weeks ]
    Physical Activity Enjoyment Scale (PACES) questionnaire

  18. Diet [ Time Frame: 16 weeks ]
    Diet diary

  19. Diet [ Time Frame: 36 weeks ]
    Diet diary


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02419482


Locations
Layout table for location information
Australia
Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC
Melbourne, Australia
Norway
Department of circulation and medical imaging , NTNU
Trondheim, Norway, 7491
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Liverpool John Moores University
Australian Catholic University
Investigators
Layout table for investigator information
Principal Investigator: Trine Moholdt, phd Norwegian University of Science and Technology
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02419482    
Other Study ID Numbers: 2015/468
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Keywords provided by Norwegian University of Science and Technology:
Exercise therapy
Reproductive Physiological Processes
Fertility
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
 Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases