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NCT Number: NCT05394935

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Behavior Cerebrovascular Circulation Cysts Endocrine System Diseases Exercise Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Motor Activity Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cardiff Metropolitan University

Cardiff, CF242SX, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

High-Intensity Exercise

Other

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

Moderate-Intensity Exercise

Other

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

Primary outcomes

  1. Cerebrovascular Reactivity to Carbon Dioxide (CO2)

    Time frame: Baseline

    6% CO2 administered to measure reactivity of the cerebrovasculature as measured by extra-cranial ultrasonography.

  2. Cerebrovascular Reactivity to Carbon Dioxide (CO2)

    Time frame: Less than 1 hour post-exercise

    6% CO2 administered to measure reactivity of the cerebrovasculature as measured by extra-cranial ultrasonography.

  3. Neurovascular coupling (NVC)

    Time frame: Baseline

    NVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.

  4. Neurovascular coupling (NVC)

    Time frame: Less than 1 hour post-exercise

    NVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.

  5. Dynamic cerebral autoregulation (dCA)

    Time frame: Baseline

    dCA will be assessed using a squat-stand method to induce forced oscillations in blood pressure and measured using finger plethysmography and transcranial Doppler.

  6. Dynamic cerebral autoregulation (dCA)

    Time frame: Less than 1 hour post-exercise

    dCA will be assessed using a squat-stand method to induce forced oscillations in blood pressure and measured using finger plethysmography and transcranial Doppler.

  7. Cerebral blood velocity in the middle (MCAv) and posterior cerebral arteries (PCAv) during exercise

    Time frame: During high-intensity exercise (24 minutes)

    MCAv and PCAv will be assessed using transcranial Doppler and employed throughout both bouts of acute exercise.

  8. Cerebral blood velocity in the middle (MCAv) and posterior cerebral arteries (PCAv) during exercise

    Time frame: During moderate-intensity exercise (50 minutes)

    MCAv and PCAv will be assessed using transcranial Doppler and employed throughout both bouts of acute exercise.

Secondary outcomes

  1. Cardiorespiratory fitness (CRF)

    Time frame: Baseline

    CRF will be assessed via peak oxygen uptake using a step protocol on a cycle ergometer. to achieve VO2peak.

  2. Cerebral structure

    Time frame: Baseline

    MRI will be employed to assess grey and white matter structure.

  3. Cerebral blood flow

    Time frame: Baseline

    Functional MRI will be employed to assess global and regional cerebral blood flow.

  4. Cerebral metabolic rate of oxygen consumption

    Time frame: Baseline

    Functional MRI will be employed to assess cerebral metabolic rate of oxygen consumption.

  5. Cerebrovascular reactivity

    Time frame: Baseline

    Functional MRI will be employed to assess cerebrovascular reactivity during a breath hold challenge.

  6. Cognitive testing

    Time frame: Baseline

    A comprehensive cognitive battery will be employed to test across multiple cognitive sub-domains (IQ, working memory, episodic memory, attention and executive function).

  7. Blood pressure during exercise

    Time frame: During High-intensity interval exercise (HIIT) (24 minutes) and Moderate-intensity steady state (MISS) (50 minutes) exercise

    Finger plethysmography will be used to non-invasively monitor systolic and diastolic blood pressure throughout both acute bouts of exercise.

  8. Hormone profile

    Time frame: Baseline

    Hormonal 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.

  9. Metabolic profile

    Time frame: Baseline

    Metabolic 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.

  10. Lipid profile

    Time frame: Baseline

    Lipid profile will be measured through blood sampling, including total cholesterol, high-density lipoproteins, low-density lipoproteins and triglycerides.

Sponsors and collaborators

Lead sponsor

Cardiff Metropolitan University

Other

Collaborators

  • Cardiff University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 27, 2022
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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