Clinical trial NCT02419482: Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training
Official title: Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Exercise therapy
Reproductive Physiological Processes
Fertility
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Liverpool John Moores University
name: Australian Catholic University
First posted: 2015-04-17
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Menstrual frequency
timeFrame: 1 year
Secondary outcomes:
measure: Body composition
timeFrame: 16 weeks, and 36 weeks
measure: Aerobic capacity
timeFrame: 16 weeks, and 36 weeks
measure: Endothelial function
timeFrame: 16 weeks, and 36 weeks
measure: Insulin sensitivity
timeFrame: 16 weeks, and 36 weeks
measure: Intima-media thickness
timeFrame: 16 weeks, and 36 weeks
measure: Oxidative capacity
timeFrame: 16 weeks, and 36 weeks
measure: Low-grade systematic inflammation
timeFrame: 16 weeks, and 36 weeks
measure: Adipose tissue morphology and function
timeFrame: 16 weeks, (and 36 weeks if funded)
measure: Hormone profile, blood lipids and blood values
timeFrame: 16 weeks, and 36 weeks
measure: Blood pressure
timeFrame: 16 weeks, and 36 weeks
measure: Quality of life
timeFrame: 16 weeks
measure: Quality of life
timeFrame: 36 weeks
measure: Physical activity
timeFrame: 16 weeks, and 36 weeks
measure: Adipose tissue mRNA expression
timeFrame: 16 weeks, (and 36 weeks if funded)
measure: ovarian morphology
timeFrame: 16 weeks, and 36 weeks
measure: Pregnancy rate
timeFrame: 16 weeks , and 36 weeks
measure: Enjoyment
timeFrame: weekly up to 16 weeks
measure: Diet
timeFrame: 16 weeks
measure: Diet
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC
city: Trondheim
country: Norway
facility: Department of circulation and medical imaging , NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Trine Moholdt, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kiel IA, Lionett S, Parr EB, Jones H, Roset MAH, Salvesen O, 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.
citation: Lionett S, Kiel IA, Rosbjorgen 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.
citation: Kiel IA, Lionett S, Parr EB, Jones H, Roset MAH, Salvesen O, 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.