Abstract

BackgroundPolycystic 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/designWe 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.DiscussionThis 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 registrationAustralian New Zealand Clinical Trials Registry, ACTRN12615000242527. Registered on 17 March 2015.

Highlights

  • Polycystic ovary syndrome (PCOS) is a reproductive-metabolic condition

  • Hiam et al Trials (2019) 20:221 (Continued from previous page). 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

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Summary

Discussion

PCOS is under-recognised by health professionals and leaves women on track for a plethora of chronic conditions ranging from anxiety and depression to diabetes, subfertility, cardiovascular disease and stroke [1, 50,51,52]. We describe the protocol of a study evaluating the effectiveness and mechanistic impacts of a practical allied health supervised 12-week HIIT or moderate intensity exercise program on cardiometabolic, reproductive and mental health in overweight women with PCOS. This trial aims to demonstrate comparative efficacy of different exercise protocols to inform vital large-scale clinical trials and best clinical practice in treatment of PCOS. 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). Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations

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