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. 2019 Apr 16;20(1):221.
doi: 10.1186/s13063-019-3313-8.

The effectiveness of high intensity intermittent training on metabolic, reproductive and mental health in women with polycystic ovary syndrome: study protocol for the iHIT- randomised controlled trial

Danielle Hiam  1 , Rhiannon Patten  1 , Melanie Gibson-Helm  2 , Alba Moreno-Asso  1 , Luke McIlvenna  1 , Itamar Levinger  1   3 , Cheryce Harrison  2 , Lisa J Moran  2 , Anju Joham  2 , Alex Parker  1 , Soulmaz Shorakae  2 , David Simar  4 , Nigel Stepto  5   6
Affiliations

The effectiveness of high intensity intermittent training on metabolic, reproductive and mental health in women with polycystic ovary syndrome: study protocol for the iHIT- randomised controlled trial

Danielle Hiam et al. Trials. .

Abstract

Background: Polycystic ovary syndrome (PCOS) is a reproductive-metabolic condition. Insulin resistance is a hallmark of PCOS and is related to increased hyperandrogenism that drives inherent metabolic, reproductive and psychological features of the syndrome. Insulin resistance in women with PCOS is managed by weight loss, lifestyle interventions (i.e. exercise, diet) and insulin-sensitising medications. This manuscript describes the protocol of our study evaluating the effectiveness of high intensity intermittent training (HIIT) or moderate intensity exercise on cardiometabolic, reproductive and mental health in overweight women with PCOS.

Methods/design: We will employ a three arm, parallel-group, randomised controlled trial recruiting 60 women diagnosed with PCOS, aged between 18 and 45 years and with a body mass index (BMI) greater than 25 kg/m2. Following screening and baseline testing, women will be randomised by simple randomisation procedure using computer generated sequence allocation to undergo one of two 12-week supervised interventions: either HIIT or moderate intensity exercise (standard supervised exercise), or to standard care [Con] (unsupervised lifestyle advice) at a 1:1:1 allocation ratio. The primary outcome for this trial is to measure the improvements in metabolic health; specifically changes in insulin sensitivity in response to different exercise intensities. Baseline and post-intervention testing include anthropometric measurements, cardiorespiratory fitness testing, reproductive hormone profiles (anti-müllerian hormone and steroid profiles), metabolic health, health-related quality of life and mental health questionnaires and objective and subjective lifestyle monitoring. Reporting of the study will follow the CONSORT statement.

Discussion: This trial aims to demonstrate the comparative efficacy and maintenance of different exercise intensities to advance the understanding of PCOS management and provide insight into the optimal exercise intensity for improved cardiometabolic outcomes. Secondary outcomes will include the impact of different exercise protocols on reproductive hormone profiles, mental health and health-related quality of life.

Trial registration: Australian New Zealand Clinical Trials Registry, ACTRN12615000242527 . Registered on 17 March 2015.

Keywords: Cardiometabolic health; Cardiorespiratory fitness; Exercise; Exercise therapy; High-intensity interval training; Insulin; Mental health; Overweight; Polycystic ovary syndrome.

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Conflict of interest statement

Ethics approval and consent to participate

This study protocol has been approved by the Victoria University Human Research Ethics Committee (Reference- HRE15-298) and is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000242527). All participants will provide written informed consent prior to participation in the study to one of the research team members.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
SPIRIT flow diagram of randomised control trial. GXT graded exercise test, ECG electrocardiogram, Insulin clamp hyperinsulinemic-euglycemic clamp, DXA dual energy x-ray absorptiometry, HIIT high intensity intermittent training, SSE supervised standard exercise, Con control
See this image and copyright information in PMC

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References

    1. Bozdag G, Mumusoglu S, Zengin D, Karabulut E, Yildiz BO. The prevalence and phenotypic features of polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod. 2016;31(12):2841–2855. doi: 10.1093/humrep/dew218. - DOI - PubMed
    1. Dunaif A, Segal KR, Futterweit W, Dobrjansky A. Profound peripheral insulin resistance, independent of obesity, in polycystic ovary syndrome. Diabetes. 1989;38(9):1165–1174. doi: 10.2337/diab.38.9.1165. - DOI - PubMed
    1. Stepto NK, Cassar S, Joham AE, Hutchison SK, Harrison CL, Goldstein RF, et al. Women with polycystic ovary syndrome have intrinsic insulin resistance on euglycaemic-hyperinsulaemic clamp. Hum Reprod. 2013;28(3):777–784. doi: 10.1093/humrep/des463. - DOI - PubMed
    1. Harrison CL, Stepto NK, Hutchison SK, Teede HJ. The impact of intensified exercise training on insulin resistance and fitness in overweight and obese women with and without polycystic ovary syndrome. Clin Endocrinol. 2012;76(3):351–357. doi: 10.1111/j.1365-2265.2011.04160.x. - DOI - PubMed
    1. Shorakae S, Boyle J, Teede H. Polycystic ovary syndrome: a common hormonal condition with major metabolic sequelae that physicians should know about. Intern Med J. 2014;44(8):720–726. doi: 10.1111/imj.12495. - DOI - PubMed

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