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, Rhiannon Patten, Melanie Gibson-Helm, Alba Moreno-Asso, Luke McIlvenna, Itamar Levinger, Cheryce Harrison, Lisa J Moran, Anju Joham, Alex Parker, Soulmaz Shorakae, David Simar, Nigel Stepto

Research output: Contribution to journalArticleOtherpeer-review

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/m 2 . 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.

Original languageEnglish
Article number221
Number of pages9
JournalTrials
Volume20
Issue number1
DOIs
Publication statusPublished - 16 Apr 2019

Keywords

  • Cardiometabolic health
  • Cardiorespiratory fitness
  • Exercise
  • Exercise therapy
  • High-intensity interval training
  • Insulin
  • Mental health
  • Overweight
  • Polycystic ovary syndrome

Cite this

Hiam, Danielle ; Patten, Rhiannon ; Gibson-Helm, Melanie ; Moreno-Asso, Alba ; McIlvenna, Luke ; Levinger, Itamar ; Harrison, Cheryce ; Moran, Lisa J ; Joham, Anju ; Parker, Alex ; Shorakae, Soulmaz ; Simar, David ; Stepto, Nigel. / 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. In: Trials. 2019 ; Vol. 20, No. 1.
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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/m 2 . 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-m{\"u}llerian 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.",
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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. / Hiam, Danielle; Patten, Rhiannon; Gibson-Helm, Melanie; Moreno-Asso, Alba; McIlvenna, Luke; Levinger, Itamar; Harrison, Cheryce; Moran, Lisa J; Joham, Anju; Parker, Alex; Shorakae, Soulmaz; Simar, David; Stepto, Nigel.

In: Trials, Vol. 20, No. 1, 221, 16.04.2019.

Research output: Contribution to journalArticleOtherpeer-review

TY - JOUR

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T2 - Study protocol for the iHIT- randomised controlled trial

AU - Hiam, Danielle

AU - Patten, Rhiannon

AU - Gibson-Helm, Melanie

AU - Moreno-Asso, Alba

AU - McIlvenna, Luke

AU - Levinger, Itamar

AU - Harrison, Cheryce

AU - Moran, Lisa J

AU - Joham, Anju

AU - Parker, Alex

AU - Shorakae, Soulmaz

AU - Simar, David

AU - Stepto, Nigel

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AB - 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/m 2 . 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.

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KW - Exercise therapy

KW - High-intensity interval training

KW - Insulin

KW - Mental health

KW - Overweight

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