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

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05394935
• Other study ID #: STA-1653
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 2024

Study information

• Verified date: October 2022
• Source: Cardiff Metropolitan University
• Contact: Aled Rees, Prof.
• Phone: 02920 745002
• Email: reesda[@]cardiff.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cerebrovascular Circulation
• Exercise
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• High-Intensity Exercise
Acute, low-volume HIIT 12x (1min:1min) Working intensity: >85% heart rate reserve Resting intensity: Active rest
• Moderate-Intensity Exercise
Continuous, MISS 50mins Working intensity: 50-60% heart rate reserve

Locations

Country	Name	City	State
United Kingdom	Cardiff Metropolitan University	Cardiff

Sponsors (2)

Lead Sponsor	Collaborator
Cardiff Metropolitan University	Cardiff University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebrovascular Reactivity to Carbon Dioxide (CO2)	6% CO2 administered to measure reactivity of the cerebrovasculature as measured by extra-cranial ultrasonography.	Baseline
Primary	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
Primary	Neurovascular coupling (NVC)	NVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.	Baseline
Primary	Neurovascular coupling (NVC)	NVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.	Less than 1 hour post-exercise
Primary	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
Primary	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
Primary	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)
Primary	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	Cardiorespiratory fitness (CRF)	CRF will be assessed via peak oxygen uptake using a step protocol on a cycle ergometer. to achieve VO2peak.	Baseline
Secondary	Cerebral structure	MRI will be employed to assess grey and white matter structure.	Baseline
Secondary	Cerebral blood flow	Functional MRI will be employed to assess global and regional cerebral blood flow.	Baseline
Secondary	Cerebral metabolic rate of oxygen consumption	Functional MRI will be employed to assess cerebral metabolic rate of oxygen consumption.	Baseline
Secondary	Cerebrovascular reactivity	Functional MRI will be employed to assess cerebrovascular reactivity during a breath hold challenge.	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Lipid profile	Lipid profile will be measured through blood sampling, including total cholesterol, high-density lipoproteins, low-density lipoproteins and triglycerides.	Baseline