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

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.

Study Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome; Exercise; Cerebrovascular Circulation
• Intervention / Treatment: Other: High-Intensity Exercise; Other: Moderate-Intensity Exercise

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aled Rees, Prof.; Phone Number: 02920 745002; Email: reesda@cardiff.ac.uk

Study Locations

• United Kingdom
  • Cardiff, United Kingdom, CF242SX
    • Recruiting
    • Cardiff Metropolitan University
    • Contact: Aled Rees, Prof.; Phone Number: 02920 745002; Email: reesda@cardiff.ac.uk
    • Sub-Investigator: Cory T Richards, MSc
    • Principal Investigator: Rachel N Lord, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polycystic Ovary Syndrome; Women with PCOS	Other: High-Intensity Exercise; Acute, low-volume HIIT 12x (1min:1min) Working intensity: >85% heart rate reserve Resting intensity: Active rest; Other: Moderate-Intensity Exercise; Continuous, MISS 50mins Working intensity: 50-60% heart rate reserve
Active Comparator: Controls; Healthy, age and BMI matched controls	Other: High-Intensity Exercise; Acute, low-volume HIIT 12x (1min:1min) Working intensity: >85% heart rate reserve Resting intensity: Active rest; Other: Moderate-Intensity Exercise; Continuous, MISS 50mins Working intensity: 50-60% heart rate reserve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebrovascular Reactivity to Carbon Dioxide (CO2)	6% CO2 administered to measure reactivity of the cerebrovasculature as measured by extra-cranial ultrasonography.	Baseline
Cerebrovascular Reactivity to Carbon Dioxide (CO2)	6% CO2 administered to measure reactivity of the cerebrovasculature as measured by extra-cranial ultrasonography.	Less than 1 hour post-exercise
Neurovascular coupling (NVC)	NVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.	Baseline
Neurovascular coupling (NVC)	NVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.	Less than 1 hour post-exercise
Dynamic cerebral autoregulation (dCA)	dCA will be assessed using a squat-stand method to induce forced oscillations in blood pressure and measured using finger plethysmography and transcranial Doppler.	Baseline
Dynamic cerebral autoregulation (dCA)	dCA will be assessed using a squat-stand method to induce forced oscillations in blood pressure and measured using finger plethysmography and transcranial Doppler.	Less than 1 hour post-exercise
Cerebral blood velocity in the middle (MCAv) and posterior cerebral arteries (PCAv) during exercise	MCAv and PCAv will be assessed using transcranial Doppler and employed throughout both bouts of acute exercise.	During high-intensity exercise (24 minutes)
Cerebral blood velocity in the middle (MCAv) and posterior cerebral arteries (PCAv) during exercise	MCAv and PCAv will be assessed using transcranial Doppler and employed throughout both bouts of acute exercise.	During moderate-intensity exercise (50 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiorespiratory fitness (CRF)	CRF will be assessed via peak oxygen uptake using a step protocol on a cycle ergometer. to achieve VO2peak.	Baseline
Cerebral structure	MRI will be employed to assess grey and white matter structure.	Baseline
Cerebral blood flow	Functional MRI will be employed to assess global and regional cerebral blood flow.	Baseline
Cerebral metabolic rate of oxygen consumption	Functional MRI will be employed to assess cerebral metabolic rate of oxygen consumption.	Baseline
Cerebrovascular reactivity	Functional MRI will be employed to assess cerebrovascular reactivity during a breath hold challenge.	Baseline
Cognitive testing	A comprehensive cognitive battery will be employed to test across multiple cognitive sub-domains (IQ, working memory, episodic memory, attention and executive function).	Baseline
Blood pressure during exercise	Finger plethysmography will be used to non-invasively monitor systolic and diastolic blood pressure throughout both acute bouts of exercise.	During High-intensity interval exercise (HIIT) (24 minutes) and Moderate-intensity steady state (MISS) (50 minutes) exercise
Hormone profile	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.	Baseline
Metabolic profile	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.	Baseline
Lipid profile	Lipid profile will be measured through blood sampling, including total cholesterol, high-density lipoproteins, low-density lipoproteins and triglycerides.	Baseline

Collaborators and Investigators

• Sponsor: Cardiff Metropolitan University
• Collaborators: Cardiff University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; PCOS; Polycystic Ovary Syndrome; High-Intensity Interval Training; Cerebrovascular; Moderate-Intensity Steady State
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: STA-1653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Applications for access to study- and participant-level data will be considered on direct enquiry.
• IPD Sharing Time Frame: January 2024 - 5 years
• IPD Sharing Supporting Information Type: Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No