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

NCT ID: NCT05394935

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-05-25

Brief Summary

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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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome Exercise Cerebrovascular Circulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
All participant data and exercise arm will be anonymised and non-identifiable by the assessor.

Study Groups

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Polycystic Ovary Syndrome

Women with PCOS

Group Type EXPERIMENTAL

High-Intensity Exercise

Intervention Type OTHER

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

Moderate-Intensity Exercise

Intervention Type OTHER

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

Controls

Healthy, age and BMI matched controls

Group Type ACTIVE_COMPARATOR

High-Intensity Exercise

Intervention Type OTHER

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

Moderate-Intensity Exercise

Intervention Type OTHER

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

Interventions

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High-Intensity Exercise

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

Intervention Type OTHER

Moderate-Intensity Exercise

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

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cardiff University

OTHER

Sponsor Role collaborator

Cardiff Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cardiff Metropolitan University

Cardiff, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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STA-1653

Identifier Type: -

Identifier Source: org_study_id

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