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

NCT05394935 | Completed

• 1 other identifier: STA-1653
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Exercise; Cerebrovascular Circulation

Keywords

PCOS; Polycystic Ovary Syndrome; Exercise; High-Intensity Interval Training; Moderate-Intensity Steady State; Cerebrovascular

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (10)

• Cardiorespiratory fitness (CRF)

  Baseline

• Cerebral structure

  Baseline

• Cerebral blood flow

  Baseline

• Cerebral metabolic rate of oxygen consumption

  Baseline

• Cerebrovascular reactivity

  Baseline

Study Arms (2)

Polycystic Ovary Syndrome

EXPERIMENTAL

Women with PCOS

Other: High-Intensity Exercise; Other: Moderate-Intensity Exercise

Controls

ACTIVE COMPARATOR

Healthy, age and BMI matched controls

Other: High-Intensity Exercise; Other: Moderate-Intensity Exercise

Interventions

High-Intensity Exercise OTHER

Acute, low-volume HIIT 12x (1min:1min) Working intensity: \>85% heart rate reserve Resting intensity: Active rest

Controls; Polycystic Ovary Syndrome

Moderate-Intensity Exercise OTHER

Continuous, MISS 50mins Working intensity: 50-60% heart rate reserve

Controls; Polycystic Ovary Syndrome

Eligibility Criteria

• Age: 16 Years - 50 Years
• Gender Eligibility Details: Females with PCOS and healthy females acting as a controls. Eligibility of participants is via biological sex.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Polycystic Ovary Syndrome as diagnosed by any recognised criteria.
• Inactive (less than 40 mins of structured exercise per week).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cardiff Metropolitan University: lead
• Cardiff University: collaborator

Study Sites (1)

Cardiff Metropolitan University

Cardiff, CF242SX, United Kingdom

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All participant data and exercise arm will be anonymised and non-identifiable by the assessor.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: May 27, 2022
• Study Start: January 1, 2020
• Primary Completion: May 25, 2024
• Study Completion: May 25, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: January 2024 - 5 years

Locations

GB (1)