Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-02-21 @ 9:03 AM
Study NCT ID:
NCT05603169
Status:
COMPLETED
Last Update Posted:
2023-05-18
First Post:
2022-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Intensity Resistance and Aerobic Training Among Women With PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessor of this study will be kept blind of the participants treatment group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment into two groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-17', 'studyFirstSubmitDate': '2022-10-28', 'studyFirstSubmitQcDate': '2022-10-28', 'lastUpdatePostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': 'changes from Baseline to 4 weeks', 'description': 'Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.'}, {'measure': 'Body Mass Index', 'timeFrame': 'changes from 4 weeks to 8weeks', 'description': 'Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.'}, {'measure': 'Body Mass Index', 'timeFrame': 'changes from 8 weeks to 12 weeks', 'description': 'Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.'}, {'measure': 'Waist Hip Ratio', 'timeFrame': 'changes from Baseline to 4 weeks', 'description': 'The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips'}, {'measure': 'Waist Hip Ratio', 'timeFrame': 'changes from 4 weeks to 8weeks', 'description': 'The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips'}, {'measure': 'Waist Hip Ratio', 'timeFrame': 'changes from 8 weeks to 12 weeks', 'description': 'The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips'}, {'measure': 'Polycystic ovarian syndrome questionnaire (PCOSQ)', 'timeFrame': 'changes from Baseline to 6 weeks', 'description': 'The PCOSQ consists of five domains, each relating to a common symptom of PCOS; body hair, emotions, infertility, menstrual problems and infertility. Each question on the PCOSQ is associated with a 7-point scale in which 7 represents optimal function and 1 the poorest function.'}, {'measure': 'Polycystic ovarian syndrome questionnaire (PCOSQ)', 'timeFrame': 'changes from 6 weeks to 12 weeks', 'description': 'The PCOSQ consists of five domains, each relating to a common symptom of PCOS; body hair, emotions, infertility, menstrual problems and infertility. Each question on the PCOSQ is associated with a 7-point scale in which 7 represents optimal function and 1 the poorest function.'}, {'measure': 'SF-36 QOL', 'timeFrame': 'changes from Baseline to 6 weeks', 'description': 'The SF-36 is a generic patient-reported outcome measure that quantifies health status and measures health-related quality of life.The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)'}, {'measure': 'SF-36 Quality of life', 'timeFrame': 'changes from 6 weeks to 12 weeks', 'description': 'The SF-36 is a generic patient-reported outcome measure that quantifies health status and measures health-related quality of life.The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)'}], 'secondaryOutcomes': [{'measure': 'LH/FSH ratios', 'timeFrame': 'changes from Baseline to 3 Months', 'description': 'Luteinizing hormone (LH), follicle-stimulating hormone (FSH), and LH/FSH ratio will be measured when considering a PCOS diagnosis. The LH/FSH ratio is a valid and frequently employed method to test the ovulation and menstrual health of such women and have been reported by many studies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '33638879', 'type': 'BACKGROUND', 'citation': 'Benham JL, Booth JE, Corenblum B, Doucette S, Friedenreich CM, Rabi DM, Sigal RJ. Exercise training and reproductive outcomes in women with polycystic ovary syndrome: A pilot randomized controlled trial. Clin Endocrinol (Oxf). 2021 Aug;95(2):332-343. doi: 10.1111/cen.14452. Epub 2021 May 3.'}, {'pmid': '33467251', 'type': 'BACKGROUND', 'citation': 'Shele G, Genkil J, Speelman D. A Systematic Review of the Effects of Exercise on Hormones in Women with Polycystic Ovary Syndrome. J Funct Morphol Kinesiol. 2020 May 31;5(2):35. doi: 10.3390/jfmk5020035.'}, {'pmid': '27771865', 'type': 'BACKGROUND', 'citation': 'Mario FM, Graff SK, Spritzer PM. Habitual physical activity is associated with improved anthropometric and androgenic profile in PCOS: a cross-sectional study. J Endocrinol Invest. 2017 Apr;40(4):377-384. doi: 10.1007/s40618-016-0570-1. Epub 2016 Oct 22.'}, {'pmid': '34567361', 'type': 'BACKGROUND', 'citation': 'Wright PJ, Corbett CF, Pinto BM, Dawson RM, Wirth M. Resistance Training as Therapeutic Management in Women with PCOS: What is the Evidence? Int J Exerc Sci. 2021 Aug 1;14(3):840-854. doi: 10.70252/NEEX8658. eCollection 2021.'}, {'pmid': '31319405', 'type': 'BACKGROUND', 'citation': 'Kogure GS, Miranda-Furtado CL, Pedroso DCC, Ribeiro VB, Eiras MC, Silva RC, Caetano LC, Ferriani RA, Calado RT, Dos Reis RM. Effects of Progressive Resistance Training on Obesity Indices in Polycystic Ovary Syndrome and the Relationship With Telomere Length. J Phys Act Health. 2019 Aug 1;16(8):601-607. doi: 10.1123/jpah.2018-0256.'}, {'type': 'BACKGROUND', 'citation': 'Mitrašinović-Brulić M, Buljan M, Suljević D. Association of LH/FSH ratio with menstrual cycle regularity and clinical features of patients with polycystic ovary syndrome. Middle East Fertility Society Journal. 2021;26(1):40.'}]}, 'descriptionModule': {'briefSummary': 'polycystic ovarian syndrome (PCOS) is the most common endocrine female disorder, affecting 4-18% women of reproductive age. The prevalence of PCOS in South Asian women, especially in Pakistani women, is much higher (52%) as compared to white population (20 - 25% in UK). On the basis of cultural, environment, diet and lifestyle practices these women are more prone to development of such disorder. So such public health issue needs to be addressed by strong evidence conducted by a clinical trial. The current study is planned to compare effects of two different exercise protocols of high intensity on anthropometric measures, hormonal profile and quality of life.', 'detailedDescription': 'PCOS is a prevalent condition that is affecting adolescent girls now and has serious impacts on menstrual health and quality of life making them prone to early risk development for chronic metabolic diseases. The comparison between high intensity resistance and aerobic training would give results that which one is more effective in gaining benefits and better effects on overall health both physically(menstrual) as well as mentally that would eventually tell us about the quality of life of such patients.\n\nAfter the initial screening process, the participants fulfilling the Roterdam criteria, willing to participate in the exercise trial will be recruited and then randomized to the allocated groups of either high intensity resistance or high intensity aerobics. At baseline, their anthropometrics measurements, LH/FSH ratios and fasting plasma glucose test will be done. Patient will be called thrice a week for 3 months for training. It is hypothesized that high intensity resistance or high intensity aerobics will improve anthropometric measures along with hormonal profile and quality of life.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women diagnosed with PCOS according to Rotterdam criteria\n* Age limit: 18-30\n* Women who are not part of planned physical activity for the last six months.\n* BMI\\<=30\n\nExclusion Criteria:\n\n* Women with PCOS who are already on birth control or hormone therapy.\n* Women with PCOS who are already are taking some medication for psychological issues\n* Women who are already taking cholesterol control medications.\n* Women who are a part of any physical activity already'}, 'identificationModule': {'nctId': 'NCT05603169', 'briefTitle': 'High Intensity Resistance and Aerobic Training Among Women With PCOS', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of High Intensity Resistance and Aerobic Training Among Women With Polycystic Ovarian Syndrome.', 'orgStudyIdInfo': {'id': 'RiphahIU Mobeena Maqsood'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Intensity Resistance Training', 'description': 'This group will perform high intensity resistance training under supervised physiotherapist in a gym setting. The training load for the first 2 weeks will be 60%-75% of 1RM and increased to 75%-90% of 1RM the following weeks. Load would be increased if the participants will be able to perform 3 sets of 12 repetitions with that load.', 'interventionNames': ['Other: High intensity resistance Exercise Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Intensity Aerobic Training', 'description': 'This group will perform aerobic training under supervision of a physical therapist in gym setting. To calculate exercise intensity, the HR will be maintained at 75-90% of the maximum (HRmax). The training protocol will begin with a 5-minute warm-up and will end with a 5-minute cool down, during which the HR will be 60-75% of the HRmax. At least 90 min of exercise per week for obese PCOS patients, with treadmill walking that may include whole-body movement involving more than 2/3 of the muscles, the exercise intensity will be high intensity', 'interventionNames': ['Other: High intensity aerobic Exercise Training']}], 'interventions': [{'name': 'High intensity resistance Exercise Training', 'type': 'OTHER', 'description': 'The resistance training will consist of five resistance exercises (thrice a week on non-consecutive days): squat, leg press, knee extension, lunges, and abdominal crunches. Every participant will be assessed pre and post intervention for hormonal change, BMI/anthropometric measures, fasting glucose and quality of life.The plan will be followed for 12 weeks', 'armGroupLabels': ['High Intensity Resistance Training']}, {'name': 'High intensity aerobic Exercise Training', 'type': 'OTHER', 'description': 'The training protocol will begin with a 5-minute warm-up and will end with a 5-minute cool down, during which the HR will be 60-75% of the HRmax. At least 90 min of exercise per week for obese PCOS patients, with treadmill walking that may include whole-body movement involving more than 2/3 of the muscles, the exercise intensity will be high intensity', 'armGroupLabels': ['High Intensity Aerobic Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04486', 'city': 'Islamabad', 'state': 'Fedral', 'country': 'Pakistan', 'facility': 'PostGraduate Lab FRAHS', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'Huma Riaz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}