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

Abstract

IntroductionPolycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age and the leading cause of anovulatory infertility. Women with PCOS have a 15-fold higher prevalence of infertility, compared with women without PCOS, independent of body mass index (BMI). A healthy lifestyle is recommended to improve overall health and fertility in PCOS but there is limited evidence on the isolated effects of exercise, especially for reproductive outcomes. Previous findings indicate superior metabolic health benefits after vigorous compared with moderate-intensity exercise. Our primary aim is to determine the effect of high-intensity interval training (HIT) on menstrual frequency, as a proxy of reproductive function, in women with PCOS.Methods and analysisThe study is a two-centre, randomised, controlled trial with three parallel groups. Women (n=64) from Trondheim (Norway) and Melbourne (Australia) with PCOS according to the Rotterdam criteria will be randomly allocated (1:1:1) to high-volume HIT, low-volume HIT or a control group with no exercise after stratifying for BMI < or ≥ 27 kg/m2and study centre. Measurements for study end points will be undertaken at baseline, after a 16 week exercise intervention and at 12 months following baseline assessments. The primary outcome measure is menstruation frequency, measured as the number of self-reported menstrual bleedings divided by the number of expected menstrual bleedings during a 12-month period. Secondary outcome measurements include markers of cardiovascular, metabolic and reproductive health, as well as quality of life and adherence to and enjoyment of exercise.Ethics and disseminationThe Regional Committee Medical Research Ethics, Norway, and The Australian Catholic University Human Research Ethics Committee, Australia, have approved the trial protocol. This trial will provide new insight regarding the impact of exercise on fertility in PCOS. We expect this trial to contribute to new therapeutic exercise strategies as part of clinical care for women with PCOS.Trial registration numberClinical trial govNCT02419482.

Absent Exercise-Induced Improvements in Fat Oxidation in Women With Polycystic Ovary Syndrome After High-Intensity Interval Training

“…The present study is a secondary analysis of a two-center, randomized controlled trial; IMProving Reproductive function in women with Polycystic OVary syndrome with high-intensity Interval Training [IMPROV-IT (Kiel et al, 2020 ); ClinicalTrials.gov identifier: NCT02419482] conducted at the Norwegian University of Science and Technology (NTNU) in Trondheim, Norway and the Australian Catholic University (ACU) in Melbourne, VIC, Australia, and a randomized, uncontrolled trial undertaken at NTNU [The Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome trial (HIT-FAT); ClinicalTrials.gov identifier: NCT02943291]. The detailed study design for the IMPROV-IT trial has been published elsewhere (Kiel et al, 2020 ). In brief, after stratification for BMI < or ≥ 27 kg/m 2 and study center, women with PCOS were randomized in a 1:1:1 manner to 16 weeks of semi-supervised HIT or a no-exercise control group: (1) Low-volume HIT (LV-HIT), (2) High-volume HIT (HV-HIT), or (3) Non-exercise (Non-Ex).…”

“…The exercise training protocols have been described previously (Kiel et al, 2020 ). Briefly, participants walked or ran on treadmills during the supervised exercise sessions, while they could choose to perform the unsupervised exercise sessions walking or running on treadmills or outdoors.…”

Circulating and Adipose Tissue miRNAs in Women With Polycystic Ovary Syndrome and Responses to High-Intensity Interval Training

“…Forty-two women with PCOS and 12 women without PCOS (Non-PCOS) were recruited for this study, which was part of the Improving Reproductive Function in Women with Polycystic Ovary Syndrome with High-Intensity Interval Training (IMPROV-IT) trial ( Kiel et al, 2020 ) ( ClinicalTrials.gov Identifier: NCT02419482) and of the Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome trial (HIT-FAT; ClinicalTrials.gov Identifier NCT02943291). The IMPROV-IT trial is a two-center randomized controlled trial undertaken at The Norwegian University of Science and Technology (NTNU) in Trondheim, Norway and at The Australian Catholic University (ACU) in Melbourne, Australia.…”

“…The IMPROV-IT trial is a two-center randomized controlled trial undertaken at The Norwegian University of Science and Technology (NTNU) in Trondheim, Norway and at The Australian Catholic University (ACU) in Melbourne, Australia. The study protocol for the IMPROV-IT trial has been published previously ( Kiel et al, 2020 ). Non-PCOS participants were recruited only in Norway.…”

“…Participants were stratified for a BMI < or ≥27 kg/m 2 and randomly assigned in a 1:1:1 manner to one of three groups: (1) LV-HIT ( n = 13); (2) HV-HIT ( n = 14); (3) Non-exercise (Non-Ex, n = 15). The training program has been described previously ( Kiel et al, 2020 ). Briefly, exercise training was performed on a treadmill or as outdoor running/walking three times/week.…”