Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 6:30 PM
Study NCT ID:
NCT05394935
Status:
COMPLETED
Last Update Posted:
2025-02-13
First Post:
2022-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of High-intensity and Moderate-intensity Exercise on Polycystic Ovary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'All participant data and exercise arm will be anonymised and non-identifiable by the assessor.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2022-02-10', 'studyFirstSubmitQcDate': '2022-05-26', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebrovascular Reactivity to Carbon Dioxide (CO2)', 'timeFrame': 'Baseline', 'description': '6% CO2 administered to measure reactivity of the cerebrovasculature as measured by extra-cranial ultrasonography.'}, {'measure': 'Cerebrovascular Reactivity to Carbon Dioxide (CO2)', 'timeFrame': 'Less than 1 hour post-exercise', 'description': '6% CO2 administered to measure reactivity of the cerebrovasculature as measured by extra-cranial ultrasonography.'}, {'measure': 'Neurovascular coupling (NVC)', 'timeFrame': 'Baseline', 'description': 'NVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.'}, {'measure': 'Neurovascular coupling (NVC)', 'timeFrame': 'Less than 1 hour post-exercise', 'description': 'NVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.'}, {'measure': 'Dynamic cerebral autoregulation (dCA)', 'timeFrame': 'Baseline', '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.'}, {'measure': 'Dynamic cerebral autoregulation (dCA)', 'timeFrame': 'Less than 1 hour post-exercise', '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.'}, {'measure': 'Cerebral blood velocity in the middle (MCAv) and posterior cerebral arteries (PCAv) during exercise', 'timeFrame': 'During high-intensity exercise (24 minutes)', 'description': 'MCAv and PCAv will be assessed using transcranial Doppler and employed throughout both bouts of acute exercise.'}, {'measure': 'Cerebral blood velocity in the middle (MCAv) and posterior cerebral arteries (PCAv) during exercise', 'timeFrame': 'During moderate-intensity exercise (50 minutes)', 'description': 'MCAv and PCAv will be assessed using transcranial Doppler and employed throughout both bouts of acute exercise.'}], 'secondaryOutcomes': [{'measure': 'Cardiorespiratory fitness (CRF)', 'timeFrame': 'Baseline', 'description': 'CRF will be assessed via peak oxygen uptake using a step protocol on a cycle ergometer. to achieve VO2peak.'}, {'measure': 'Cerebral structure', 'timeFrame': 'Baseline', 'description': 'MRI will be employed to assess grey and white matter structure.'}, {'measure': 'Cerebral blood flow', 'timeFrame': 'Baseline', 'description': 'Functional MRI will be employed to assess global and regional cerebral blood flow.'}, {'measure': 'Cerebral metabolic rate of oxygen consumption', 'timeFrame': 'Baseline', 'description': 'Functional MRI will be employed to assess cerebral metabolic rate of oxygen consumption.'}, {'measure': 'Cerebrovascular reactivity', 'timeFrame': 'Baseline', 'description': 'Functional MRI will be employed to assess cerebrovascular reactivity during a breath hold challenge.'}, {'measure': 'Cognitive testing', 'timeFrame': 'Baseline', 'description': 'A comprehensive cognitive battery will be employed to test across multiple cognitive sub-domains (IQ, working memory, episodic memory, attention and executive function).'}, {'measure': 'Blood pressure during exercise', 'timeFrame': 'During High-intensity interval exercise (HIIT) (24 minutes) and Moderate-intensity steady state (MISS) (50 minutes) exercise', 'description': 'Finger plethysmography will be used to non-invasively monitor systolic and diastolic blood pressure throughout both acute bouts of exercise.'}, {'measure': 'Hormone profile', 'timeFrame': 'Baseline', '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.'}, {'measure': 'Metabolic profile', 'timeFrame': 'Baseline', '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.'}, {'measure': 'Lipid profile', 'timeFrame': 'Baseline', 'description': 'Lipid profile will be measured through blood sampling, including total cholesterol, high-density lipoproteins, low-density lipoproteins and triglycerides.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCOS', 'Polycystic Ovary Syndrome', 'Exercise', 'High-Intensity Interval Training', 'Moderate-Intensity Steady State', 'Cerebrovascular'], 'conditions': ['Polycystic Ovary Syndrome', 'Exercise', 'Cerebrovascular Circulation']}, 'descriptionModule': {'briefSummary': '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.\n\nAll 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.\n\nParticipants 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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nAll 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'genderBased': True, 'genderDescription': 'Females with PCOS and healthy females acting as a controls. Eligibility of participants is via biological sex.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Polycystic Ovary Syndrome as diagnosed by any recognised criteria.\n* Inactive (less than 40 mins of structured exercise per week).\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Congenital adrenal hyperplasia, Cushing's syndrome, thyroid disease, hyperprolactinaemia and androgen secreting tumours.\n* Known history of cardiovascular disease.\n* Contraindications to MRI (fitted with ferromagnetic devices)."}, 'identificationModule': {'nctId': 'NCT05394935', 'briefTitle': 'The Effects of High-intensity and Moderate-intensity Exercise on Polycystic Ovary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Cardiff Metropolitan University'}, 'officialTitle': 'The Effects of High- and Moderate-Intensity Exercise on the Cerebrovascular and Cardiometabolic Health of Women With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'STA-1653'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Polycystic Ovary Syndrome', 'description': 'Women with PCOS', 'interventionNames': ['Other: High-Intensity Exercise', 'Other: Moderate-Intensity Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Controls', 'description': 'Healthy, age and BMI matched controls', 'interventionNames': ['Other: High-Intensity Exercise', 'Other: Moderate-Intensity Exercise']}], 'interventions': [{'name': 'High-Intensity Exercise', 'type': 'OTHER', 'description': 'Acute, low-volume HIIT 12x (1min:1min) Working intensity: \\>85% heart rate reserve Resting intensity: Active rest', 'armGroupLabels': ['Controls', 'Polycystic Ovary Syndrome']}, {'name': 'Moderate-Intensity Exercise', 'type': 'OTHER', 'description': 'Continuous, MISS 50mins Working intensity: 50-60% heart rate reserve', 'armGroupLabels': ['Controls', 'Polycystic Ovary Syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF242SX', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Cardiff Metropolitan University', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}]}, 'ipdSharingStatementModule': {'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': 'January 2024 - 5 years', 'ipdSharing': 'YES', 'description': 'Applications for access to study- and participant-level data will be considered on direct enquiry.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiff Metropolitan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cardiff University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}