Clinical trial NCT05394935: 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
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Exercise
Cerebrovascular Circulation
Keywords: PCOS
Polycystic Ovary Syndrome
Exercise
High-Intensity Interval Training
Moderate-Intensity Steady State
Cerebrovascular
Lead sponsor: Cardiff Metropolitan University
Sponsor class: OTHER
Collaborators: name: Cardiff University
First posted: 2022-05-27
Enrollment: 34
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Cerebrovascular Reactivity to Carbon Dioxide (CO2)
timeFrame: Baseline
measure: Cerebrovascular Reactivity to Carbon Dioxide (CO2)
timeFrame: Less than 1 hour post-exercise
measure: Neurovascular coupling (NVC)
timeFrame: Baseline
measure: Neurovascular coupling (NVC)
timeFrame: Less than 1 hour post-exercise
measure: Dynamic cerebral autoregulation (dCA)
timeFrame: Baseline
measure: Dynamic cerebral autoregulation (dCA)
timeFrame: Less than 1 hour post-exercise
measure: Cerebral blood velocity in the middle (MCAv) and posterior cerebral arteries (PCAv) during exercise
timeFrame: During high-intensity exercise (24 minutes)
measure: Cerebral blood velocity in the middle (MCAv) and posterior cerebral arteries (PCAv) during exercise
timeFrame: During moderate-intensity exercise (50 minutes)
Secondary outcomes:
measure: Cardiorespiratory fitness (CRF)
timeFrame: Baseline
measure: Cerebral structure
timeFrame: Baseline
measure: Cerebral blood flow
timeFrame: Baseline
measure: Cerebral metabolic rate of oxygen consumption
timeFrame: Baseline
measure: Cerebrovascular reactivity
timeFrame: Baseline
measure: Cognitive testing
timeFrame: Baseline
measure: Blood pressure during exercise
timeFrame: During High-intensity interval exercise (HIIT) (24 minutes) and Moderate-intensity steady state (MISS) (50 minutes) exercise
measure: Hormone profile
timeFrame: Baseline
measure: Metabolic profile
timeFrame: Baseline
measure: Lipid profile
timeFrame: Baseline
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Cardiff Metropolitan University
Study officials:
References: