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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
journal contributionposted on 2022-03-22, 22:48 authored by D Hiam, R Patten, Melanie Gibson-HelmMelanie Gibson-Helm, A Moreno-Asso, L McIlvenna, I Levinger, C Harrison, LJ Moran, A Joham, A Parker, S Shorakae, D Simar, N Stepto
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.
Preferred citationHiam, D., Patten, R., Gibson-Helm, M., Moreno-Asso, A., McIlvenna, L., Levinger, I., Harrison, C., Moran, L. J., Joham, A., Parker, A., Shorakae, S., Simar, D. & Stepto, N. (2019). 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. Trials, 20(1), 221-. https://doi.org/10.1186/s13063-019-3313-8
PublisherSpringer Science and Business Media LLC
Online publication date2019-04-16
Cardiometabolic healthCardiorespiratory fitnessExerciseExercise therapyHigh-intensity interval trainingInsulinMental healthOverweightPolycystic ovary syndromeAdolescentAdultExercise TherapyFemaleHumansInsulin ResistanceMental HealthMiddle AgedOutcome Assessment, Health CarePolycystic Ovary SyndromeQuality of LifeRandomized Controlled Trials as TopicReproductive HealthSample SizeYoung AdultPreventionContraception/ReproductionClinical ResearchBehavioral and Social ScienceComparative Effectiveness ResearchDiabetesInfertilityClinical Trials and Supportive ActivitiesObesityNutrition6.7 PhysicalMetabolic and endocrineReproductive health and childbirthCardiovascular System & HematologyGeneral & Internal MedicineCardiorespiratory Medicine and Haematology not elsewhere classifiedClinical Sciences not elsewhere classified