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

Primary Purpose

Polycystic Ovary Syndrome, Exercise, Cerebrovascular Circulation

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High-Intensity Exercise
Moderate-Intensity Exercise
Sponsored by
Cardiff Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, Polycystic Ovary Syndrome, Exercise, High-Intensity Interval Training, Moderate-Intensity Steady State, Cerebrovascular

Eligibility Criteria

16 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Cardiff Metropolitan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Polycystic Ovary Syndrome

Controls

Arm Description

Women with PCOS

Healthy, age and BMI matched controls

Outcomes

Primary Outcome Measures

Cerebrovascular Reactivity to Carbon Dioxide (CO2)
6% CO2 administered to measure reactivity of the cerebrovasculature as measured by extra-cranial ultrasonography.
Cerebrovascular Reactivity to Carbon Dioxide (CO2)
6% CO2 administered to measure reactivity of the cerebrovasculature as measured by extra-cranial ultrasonography.
Neurovascular coupling (NVC)
NVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.
Neurovascular coupling (NVC)
NVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.
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.
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.
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.
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.

Secondary Outcome Measures

Cardiorespiratory fitness (CRF)
CRF will be assessed via peak oxygen uptake using a step protocol on a cycle ergometer. to achieve VO2peak.
Cerebral structure
MRI will be employed to assess grey and white matter structure.
Cerebral blood flow
Functional MRI will be employed to assess global and regional cerebral blood flow.
Cerebral metabolic rate of oxygen consumption
Functional MRI will be employed to assess cerebral metabolic rate of oxygen consumption.
Cerebrovascular reactivity
Functional MRI will be employed to assess cerebrovascular reactivity during a breath hold challenge.
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).
Blood pressure during exercise
Finger plethysmography will be used to non-invasively monitor systolic and diastolic blood pressure throughout both acute bouts of 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.
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.
Lipid profile
Lipid profile will be measured through blood sampling, including total cholesterol, high-density lipoproteins, low-density lipoproteins and triglycerides.

Full Information

First Posted
February 10, 2022
Last Updated
October 20, 2022
Sponsor
Cardiff Metropolitan University
Collaborators
Cardiff University
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1. Study Identification

Unique Protocol Identification Number
NCT05394935
Brief Title
The Effects of High-intensity and Moderate-intensity Exercise on Polycystic Ovary Syndrome
Official Title
The Effects of High- and Moderate-Intensity Exercise on the Cerebrovascular and Cardiometabolic Health of Women With Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiff Metropolitan University
Collaborators
Cardiff University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Exercise, Cerebrovascular Circulation
Keywords
PCOS, Polycystic Ovary Syndrome, Exercise, High-Intensity Interval Training, Moderate-Intensity Steady State, Cerebrovascular

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Outcomes Assessor
Masking Description
All participant data and exercise arm will be anonymised and non-identifiable by the assessor.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Polycystic Ovary Syndrome
Arm Type
Experimental
Arm Description
Women with PCOS
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
Healthy, age and BMI matched controls
Intervention Type
Other
Intervention Name(s)
High-Intensity Exercise
Intervention Description
Acute, low-volume HIIT 12x (1min:1min) Working intensity: >85% heart rate reserve Resting intensity: Active rest
Intervention Type
Other
Intervention Name(s)
Moderate-Intensity Exercise
Intervention Description
Continuous, MISS 50mins Working intensity: 50-60% heart rate reserve
Primary Outcome Measure Information:
Title
Cerebrovascular Reactivity to Carbon Dioxide (CO2)
Description
6% CO2 administered to measure reactivity of the cerebrovasculature as measured by extra-cranial ultrasonography.
Time Frame
Baseline
Title
Cerebrovascular Reactivity to Carbon Dioxide (CO2)
Description
6% CO2 administered to measure reactivity of the cerebrovasculature as measured by extra-cranial ultrasonography.
Time Frame
Less than 1 hour post-exercise
Title
Neurovascular coupling (NVC)
Description
NVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.
Time Frame
Baseline
Title
Neurovascular coupling (NVC)
Description
NVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.
Time Frame
Less than 1 hour post-exercise
Title
Dynamic cerebral autoregulation (dCA)
Description
dCA will be assessed using a squat-stand method to induce forced oscillations in blood pressure and measured using finger plethysmography and transcranial Doppler.
Time Frame
Baseline
Title
Dynamic cerebral autoregulation (dCA)
Description
dCA will be assessed using a squat-stand method to induce forced oscillations in blood pressure and measured using finger plethysmography and transcranial Doppler.
Time Frame
Less than 1 hour post-exercise
Title
Cerebral blood velocity in the middle (MCAv) and posterior cerebral arteries (PCAv) during exercise
Description
MCAv and PCAv will be assessed using transcranial Doppler and employed throughout both bouts of acute exercise.
Time Frame
During high-intensity exercise (24 minutes)
Title
Cerebral blood velocity in the middle (MCAv) and posterior cerebral arteries (PCAv) during exercise
Description
MCAv and PCAv will be assessed using transcranial Doppler and employed throughout both bouts of acute exercise.
Time Frame
During moderate-intensity exercise (50 minutes)
Secondary Outcome Measure Information:
Title
Cardiorespiratory fitness (CRF)
Description
CRF will be assessed via peak oxygen uptake using a step protocol on a cycle ergometer. to achieve VO2peak.
Time Frame
Baseline
Title
Cerebral structure
Description
MRI will be employed to assess grey and white matter structure.
Time Frame
Baseline
Title
Cerebral blood flow
Description
Functional MRI will be employed to assess global and regional cerebral blood flow.
Time Frame
Baseline
Title
Cerebral metabolic rate of oxygen consumption
Description
Functional MRI will be employed to assess cerebral metabolic rate of oxygen consumption.
Time Frame
Baseline
Title
Cerebrovascular reactivity
Description
Functional MRI will be employed to assess cerebrovascular reactivity during a breath hold challenge.
Time Frame
Baseline
Title
Cognitive testing
Description
A comprehensive cognitive battery will be employed to test across multiple cognitive sub-domains (IQ, working memory, episodic memory, attention and executive function).
Time Frame
Baseline
Title
Blood pressure during exercise
Description
Finger plethysmography will be used to non-invasively monitor systolic and diastolic blood pressure throughout both acute bouts of exercise.
Time Frame
During High-intensity interval exercise (HIIT) (24 minutes) and Moderate-intensity steady state (MISS) (50 minutes) exercise
Title
Hormone profile
Description
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.
Time Frame
Baseline
Title
Metabolic profile
Description
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.
Time Frame
Baseline
Title
Lipid profile
Description
Lipid profile will be measured through blood sampling, including total cholesterol, high-density lipoproteins, low-density lipoproteins and triglycerides.
Time Frame
Baseline

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females with PCOS and healthy females acting as a controls. Eligibility of participants is via biological sex.
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aled Rees, Prof.
Phone
02920 745002
Email
reesda@cardiff.ac.uk
Facility Information:
Facility Name
Cardiff Metropolitan University
City
Cardiff
ZIP/Postal Code
CF242SX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aled Rees, Prof.
Phone
02920 745002
Email
reesda@cardiff.ac.uk
First Name & Middle Initial & Last Name & Degree
Cory T Richards, MSc
First Name & Middle Initial & Last Name & Degree
Rachel N Lord, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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