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The (i)mpact of (H)igh (I)ntensity intermittent (T)raining on health and mechanisms of insulin resistance in women with (P)oly(c)ystic (O)vary (S)yndrome: The iHIT-PCOS randomised control trial.

A randomized control trial comparing the impacts of high intensity intermittent exercise to current physical activity guideline recommendations and standard care on reproductive health, health related quality of life and mechanisms of insulin resistance in overweight women with Polycystic Ovary Syndrome

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000242527
Acronym
iHIT-PCOS
Enrollment
34
Registered
2015-03-17
Start date
2016-06-01
Completion date
2019-05-16
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Polycystic ovary syndrome (PCOS) is a major public health concern affecting one in five young Australian women and costs the country $800 million/y. It has significant metabolic [diabetes (T2DM) and adverse cardiovascular risk factors (CVRF)] and reproductive [sub-fertility and menstrual disturbance] consequences that are underpinned by insulin resistance (IR) and exacerbated by obesity. Despite the successful work of our group and others, gaps remain in understanding the mechanisms of IR in PCOS and in determining optimal therapies – including exercise interventions. We will advance understanding of the biological origins of PCOS, and of optimal therapies. Using gold-standard measures of insulin sensitivity and advanced molecular techniques we will significantly advance knowledge on mechanisms of IR in PCOS including ectopic lipid accumulation, tissue fibrosis, and epigenetics and the impact of exercise in a randomised control trial. We will recruit 60 over weight women with PCOS and compare the benefits and impact of high-intensity intermittent training (HIIT), with standard exercise recommendations or lifestyle advice. The impact of HIIT on these mechanisms will be elucidated, clarifying its value as an effective lifestyle intervention. This work will reveal mechanisms of IR and impact of exercise in PCOS, uncover potential therapeutic targets for IR in PCOS and obesity and inform optimal exercise prescription for lifestyle therapy.

Interventions

Women will be randomized into the control and 2 exercise intervention groups. Three weeks prior to the exercise intervention phase women in all groups will undertake a behavioural lifestyle intervention: an adapted, evidence based lifestyle behavioural intervention will be provided to all participants to i) ensure exercise is provided in context of combined behavioural and dietary intervention and ii) to optimise retention, engagement, motivation and sustainability of exercise. This program incl

Women will be randomized into the control and 2 exercise intervention groups. Three weeks prior to the exercise intervention phase women in all groups will undertake a behavioural lifestyle intervention: an adapted, evidence based lifestyle behavioural intervention will be provided to all participants to i) ensure exercise is provided in context of combined behavioural and dietary intervention and ii) to optimise retention, engagement, motivation and sustainability of exercise. This program includes provision of healthy eating advice and health promotion behaviour change principles resulting in improved retention (~10% attrition rates in 3 large prior RCT’s compared to standard ~30% dropout rates). This involves 3 x 1 hour group sessions (1 session per week over 3 weeks) focused on diet information and behavioural modification techniques based on social cognitive theory including goal setting, self-monitoring, social support, coping strategies, problem solving and relapse prevention . Non-prescriptive and non-individualised dietary advice is provided consistent with the Australian Dietary and Healthy Eating Guidelines with a focus on healthy food choices, reducing intake of energy-dense and non-core foods and increasing intake of low energy-dense foods. These sessions encourage physical activity (low intensity exercise for 150 minutes/week) but do not include structured exercise. Lifestyle sessions will be provided by trained accredited exercise physiologists (AEPs). Exercise treatments: Exercise will be conducted in group setting on stationary bikes or treadmills according to the participant’s preference; and exercise intensities prescribed and monitored using heart rates. Sessions will be conducted at the university fitness centre/ exercise clinic under the supervision of AEPs, Volume matching and training progression: The supervised standard exercise recommendation (SSE) and High intensity intermittent training (HIIT) intervention arms will be matched for training volume (MET.min/week) and progressed weekly by manipulating session time and intensity. Both SSE and HIIT will progress from 312 MET.min/week in week 1 to 530 MET.min/week in weeks 8-12, meeting exercise guideline minimums. Exercise sessions include warm-up and cool down protocols, and are adjusted to individual capabilities and training adaptations. In addition to lifestyle intervention and wearable technology, details of the three exercise treatment arms are: i) Control Group: Exercise advice but without structured exercise as per standard care. ii) SSE Group: Supervised standard exercise recommendations at minimum exercise/ physical activity recommendations (150 min per week) in three supervised sessions/week of continuous low to moderate intensity exercise sessions (building up to 50 min sessions of cycling/walking at 3.3 METs or 50-60% HRR). iii) HIIT Group: Vigorous exercise at minimum exercise/physical activity recommendations (~75 min per week) in three supervised sessions/week of HIIT exercise (cycling/running). Based on existing literature and patient consultation, we will use a practical training program encompassing two successful HIIT protocols: * two sessions/week of short constant load cycling of 8–12 x 1 min at ~9METs (or 90-95% HRR) with 1 minute passive recovery * one session/week of cycling/jogging/running 4–8 x 4 min at 8 METS (or 70-85%HRR) with 1 minute passive recovery. These HIIT sessions have proven feasible, enjoyable, and are safe in populations with significant metabolic disease and in the pilot study in overweight PCOS women, and is best tolerated with progressive weekly increases, as per best-practice exercise prescription principles.

Sponsors

Victoria University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

Must be diagnosed with Polycystic Ovary Syndrome by Rotterdam criteria as recommended criteria by both the NHMRC approved guideline for managing and treating PCOS and a recent NIH workshop with exclusion of other causes of hyperandrogenism (thyroid and prolactin disorders and non-classical congenital adrenal hyperplasia). The diagnostic criteria Polycystic Ovary syndrome include two of (i) irregular menstrual cycles (<21 or >35 days), (ii) clinical (hirsutism, acne) or biochemical (elevation of at least one circulating ovarian androgen) hyperandrogenism and (iii) Polycystic ovaries on ultrasound.Must have a BMI>25 m/kg2

Exclusion criteria

Secondary causes of menstrual disturbance and hyperandrogenism, pregnancy (pregnancy test at baseline), smoking, diabetes, uncontrolled hypertension (>160/100), established CVD, renal impairment and malignancy, clinical depression, those on medications that interfere with end-points (e.g. anti-hypertensives, lipid-lowering agents) or >75min/week exercise as this is 50% of minimum recommended physical activity.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 3, 2026