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The Effects of High-intensity and Moderate-intensity Exercise on Polycystic Ovary Syndrome

The Effects of High- and Moderate-Intensity Exercise on the Cerebrovascular and Cardiometabolic Health of Women With Polycystic Ovary Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05394935
Enrollment
34
Registered
2022-05-27
Start date
2020-01-01
Completion date
2024-05-25
Last updated
2025-02-13

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

Conditions

Polycystic Ovary Syndrome, Exercise, Cerebrovascular Circulation

Keywords

PCOS, Polycystic Ovary Syndrome, Exercise, High-Intensity Interval Training, Moderate-Intensity Steady State, Cerebrovascular

Brief summary

This study will investigate the impact of high- and moderate-intensity exercise on the cardiometabolic and brain health of women with Polycystic Ovary syndrome (PCOS). The aim is to measure and compare normal, healthy women without PCOS, to those with the condition. All participants will undergo a blood test. The investigators will then assess the participants cardiovascular fitness by means of a maximal exercise test and measure body composition through height, weight, and hip-to-waist ratio. Participants will undergo an MRI, where the investigators will assess the participants brain structure and how the brain responds to a number of tests. The investigators will also conduct some tests that will assess the participants cognition, such as IQ, memory etc. The investigators will measure the blood vessels leading to the brain and the blood flow through them to measure how much blood the brain receives when rested, using ultrasound. The investigators will use a number of tests to look at brain function, measure the responses to these tests, and compare them between the normal, healthy women and those with PCOS. This will show if women with PCOS have a similar brain function when rested and when their brains are tested to those without the condition. The investigators will use exercise as an intervention, where the aim will be to investigate whether women with PCOS respond similarly to those without the condition to both high-intensity and moderate-intensity exercise. The tests of brain function will be repeated following the exercise, and see if both normal, healthy women and those with PCOS have a similar response to the brain function tests. All tests and measures will be compared between the PCOS group, and the healthy control group to establish any potential differences or similarities as a result of the condition.

Interventions

Acute, low-volume HIIT 12x (1min:1min) Working intensity: \>85% heart rate reserve Resting intensity: Active rest

Continuous, MISS 50mins Working intensity: 50-60% heart rate reserve

Sponsors

Cardiff University
CollaboratorOTHER
Cardiff Metropolitan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

All participant data and exercise arm will be anonymised and non-identifiable by the assessor.

Intervention model description

Participants will complete multiple baseline assessments. Within the crossover model, participants will complete a baseline cerebrovascular assessment, followed by a random bout of acute exercise and then a post-exercise repeat of the baseline tests. Following a pre-designated washout, the participants will complete the same visit with the remaining exercise bout.

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Polycystic Ovary Syndrome as diagnosed by any recognised criteria. * Inactive (less than 40 mins of structured exercise per week).

Exclusion criteria

* Pregnant or breastfeeding. * Congenital adrenal hyperplasia, Cushing's syndrome, thyroid disease, hyperprolactinaemia and androgen secreting tumours. * Known history of cardiovascular disease. * Contraindications to MRI (fitted with ferromagnetic devices).

Design outcomes

Primary

MeasureTime frameDescription
Cerebrovascular Reactivity to Carbon Dioxide (CO2)Baseline6% CO2 administered to measure reactivity of the cerebrovasculature as measured by extra-cranial ultrasonography.
Neurovascular coupling (NVC)BaselineNVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.
Dynamic cerebral autoregulation (dCA)BaselinedCA will be assessed using a squat-stand method to induce forced oscillations in blood pressure and measured using finger plethysmography and transcranial Doppler.
Cerebral blood velocity in the middle (MCAv) and posterior cerebral arteries (PCAv) during exerciseDuring high-intensity exercise (24 minutes)MCAv and PCAv will be assessed using transcranial Doppler and employed throughout both bouts of acute exercise.

Secondary

MeasureTime frameDescription
Cerebrovascular reactivityBaselineFunctional MRI will be employed to assess cerebrovascular reactivity during a breath hold challenge.
Cognitive testingBaselineA comprehensive cognitive battery will be employed to test across multiple cognitive sub-domains (IQ, working memory, episodic memory, attention and executive function).
Blood pressure during exerciseDuring High-intensity interval exercise (HIIT) (24 minutes) and Moderate-intensity steady state (MISS) (50 minutes) exerciseFinger plethysmography will be used to non-invasively monitor systolic and diastolic blood pressure throughout both acute bouts of exercise.
Cardiorespiratory fitness (CRF)BaselineCRF will be assessed via peak oxygen uptake using a step protocol on a cycle ergometer. to achieve VO2peak.
Metabolic profileBaselineMetabolic profile will be measured through blood sampling, including fasting glucose and fasting insulin. From these values, the homeostatic model assessment of insulin resistance (HOMA-IR) will be calculated.
Lipid profileBaselineLipid profile will be measured through blood sampling, including total cholesterol, high-density lipoproteins, low-density lipoproteins and triglycerides.
Hormone profileBaselineHormonal profile will be measured through blood sampling, including androstenedione, sex hormone binding globulin and testosterone. From these values, free androgen index (FAI) will be calculated.
Cerebral structureBaselineMRI will be employed to assess grey and white matter structure.
Cerebral blood flowBaselineFunctional MRI will be employed to assess global and regional cerebral blood flow.
Cerebral metabolic rate of oxygen consumptionBaselineFunctional MRI will be employed to assess cerebral metabolic rate of oxygen consumption.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026