Polycystic Ovary SyndromeNCT05394935
The Effects of High-intensity and Moderate-intensity Exercise on Polycystic Ovary Syndrome
A study testing High-Intensity Exercise and Moderate-Intensity Exercise in people with Polycystic Ovary Syndrome and Exercise, run by Cardiff Metropolitan University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Exercise, Cerebrovascular Circulation
- What is being tested?
- High-Intensity Exercise and Moderate-Intensity Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2020to 25 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Polycystic Ovary Syndrome as diagnosed by any recognised criteria.
- Inactive (less than 40 mins of structured exercise per week).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- High-Intensity Exercise, Moderate-Intensity Exercise
- Keywords
- PCOS, Polycystic Ovary Syndrome, Exercise, High-Intensity Interval Training, Moderate-Intensity Steady State, Cerebrovascular
- Medical subject headings
- Polycystic Ovary Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity ExerciseOther
Acute, low-volume HIIT 12x (1min:1min) Working intensity: >85% heart rate reserve Resting intensity: Active rest
Moderate-Intensity ExerciseOther
Continuous, MISS 50mins Working intensity: 50-60% heart rate reserve
| Study group | Role | What they receive |
|---|---|---|
| Polycystic Ovary Syndrome | Experimental | Women with PCOS Receives: Other: High-Intensity Exercise; Other: Moderate-Intensity Exercise |
| Controls | Active comparator | Healthy, age and BMI matched controls Receives: Other: High-Intensity Exercise; Other: Moderate-Intensity Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrovascular Reactivity to Carbon Dioxide (CO2)
6% CO2 administered to measure reactivity of the cerebrovasculature as measured by extra-cranial ultrasonography.
Measured: Baseline
Cerebrovascular Reactivity to Carbon Dioxide (CO2)
6% CO2 administered to measure reactivity of the cerebrovasculature as measured by extra-cranial ultrasonography.
Measured: Less than 1 hour post-exercise
Neurovascular coupling (NVC)
NVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.
Measured: Baseline
Neurovascular coupling (NVC)
NVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During moderate-intensity exercise (50 minutes)
Secondary outcomes (10)
Cardiorespiratory fitness (CRF)
CRF will be assessed via peak oxygen uptake using a step protocol on a cycle ergometer. to achieve VO2peak.
Measured: Baseline
Cerebral structure
MRI will be employed to assess grey and white matter structure.
Measured: Baseline
Cerebral blood flow
Functional MRI will be employed to assess global and regional cerebral blood flow.
Measured: Baseline
Cerebral metabolic rate of oxygen consumption
Functional MRI will be employed to assess cerebral metabolic rate of oxygen consumption.
Measured: Baseline
Cerebrovascular reactivity
Functional MRI will be employed to assess cerebrovascular reactivity during a breath hold challenge.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Lipid profile
Lipid profile will be measured through blood sampling, including total cholesterol, high-density lipoproteins, low-density lipoproteins and triglycerides.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Jan 2020
- Primary completion25 May 2024
- Study completion25 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiff University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394935
- Sponsor's protocol ID
- STA-1653
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2022
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Applications for access to study- and participant-level data will be considered on direct enquiry.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High- and Moderate-Intensity Exercise on the Cerebrovascular and Cardiometabolic Health of Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT05394935
- Acronym / sponsor ID
- STA-1653
- Keywords
- PCOS, Polycystic Ovary Syndrome, Exercise, High-Intensity Interval Training, Moderate-Intensity Steady State, Cerebrovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cardiff Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Cardiff University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 25 May 2024 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Polycystic Ovary Syndrome | Experimental | Other: High-Intensity Exercise, Other: Moderate-Intensity ExerciseWomen with PCOS |
| Controls | Active comparator | Other: High-Intensity Exercise, Other: Moderate-Intensity ExerciseHealthy, age and BMI matched controls |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Polycystic Ovary Syndrome as diagnosed by any recognised criteria.
- Inactive (less than 40 mins of structured exercise per week).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity ExerciseAcute, low-volume HIIT 12x (1min:1min) Working intensity: >85% heart rate reserve Resting intensity: Active rest | Other | Controls, Polycystic Ovary Syndrome |
| Moderate-Intensity ExerciseContinuous, MISS 50mins Working intensity: 50-60% heart rate reserve | Other | Controls, Polycystic Ovary Syndrome |
Primary outcome
Cerebrovascular Reactivity to Carbon Dioxide (CO2)
Time frame: Baseline
6% CO2 administered to measure reactivity of the cerebrovasculature as measured by extra-cranial ultrasonography.
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.
Neurovascular coupling (NVC)
Time frame: Baseline
NVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.
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.
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.
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.
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.
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.
10 secondary outcomes
Cardiorespiratory fitness (CRF)
Time frame: Baseline
Cerebral structure
Time frame: Baseline
Cerebral blood flow
Time frame: Baseline
Cerebral metabolic rate of oxygen consumption
Time frame: Baseline
Cerebrovascular reactivity
Time frame: Baseline
Cognitive testing
Time frame: Baseline
Blood pressure during exercise
Time frame: During High-intensity interval exercise (HIIT) (24 minutes) and Moderate-intensity steady state (MISS) (50 minutes) exercise
Hormone profile
Time frame: Baseline
Metabolic profile
Time frame: Baseline
Lipid profile
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: Yes. Applications for access to study- and participant-level data will be considered on direct enquiry.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Exercise and Moderate-Intensity Exercise in people with Polycystic Ovary Syndrome and Exercise, run by Cardiff Metropolitan University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrovascular Reactivity to Carbon Dioxide (CO2) (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.