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

• ClinicalTrials.gov Identifier: NCT02419482
• Recruitment Status: Completed
• First Posted: April 17, 2015
• Last Update Posted: September 2, 2020
• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; Liverpool John Moores University; Australian Catholic University
• Information provided by (Responsible Party): Norwegian University of Science and Technology

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Locations

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

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

More Information

Publications of Results:

Lionett S, Kiel IA, Camera DM, Vanky E, Parr EB, Lydersen S, Hawley JA, Moholdt T. Circulating and Adipose Tissue miRNAs in Women With Polycystic Ovary Syndrome and Responses to High-Intensity Interval Training. Front Physiol. 2020 Jul 30;11:904. doi: 10.3389/fphys.2020.00904. eCollection 2020.

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

Kiel IA, Lionett S, Parr EB, Jones H, Røset MAH, Salvesen Ø, Hawley JA, Vanky E, Moholdt T. High-Intensity Interval Training in Polycystic Ovary Syndrome: A Two-Center, Three-Armed Randomized Controlled Trial. Med Sci Sports Exerc. 2022 May 1;54(5):717-727. doi: 10.1249/MSS.0000000000002849. Epub 2022 Jan 12.

Lionett S, Kiel IA, Røsbjørgen R, Lydersen S, Larsen S, Moholdt T. Absent Exercise-Induced Improvements in Fat Oxidation in Women With Polycystic Ovary Syndrome After High-Intensity Interval Training. Front Physiol. 2021 Mar 24;12:649794. doi: 10.3389/fphys.2021.649794. eCollection 2021.

Kiel IA, Lionett S, Parr EB, Jones H, Røset MAH, Salvesen Ø, Vanky E, Moholdt T. Improving reproductive function in women with polycystic ovary syndrome with high-intensity interval training (IMPROV-IT): study protocol for a two-centre, three-armed randomised controlled trial. BMJ Open. 2020 Feb 20;10(2):e034733. doi: 10.1136/bmjopen-2019-034733.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT02419482
• Other Study ID Numbers: 2015/468
• First Posted: April 17, 2015
• 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:

Polycystic Ovary Syndrome; Syndrome; Disease; Pathologic Processes; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases