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Trial record 35 of 46062 for:    intensity

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

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ClinicalTrials.gov Identifier: NCT02419482
Recruitment Status : Active, not recruiting
First Posted : April 17, 2015
Last Update Posted : May 2, 2019
Sponsor:
Collaborators:
St. Olavs Hospital
Liverpool John Moores University
Australian Catholic University
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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

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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
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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



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, and 36 weeks ]
    Questionnaire (PCOS-specific)

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

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

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

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



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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:

  • 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

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
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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
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Principal Investigator: Trine Moholdt, phd Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02419482     History of Changes
Other Study ID Numbers: 2015/468
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Keywords provided by Norwegian University of Science and Technology:
Exercise therapy
Reproductive Physiological Processes
Fertility
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