Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-01-05 @ 6:33 PM
Study NCT ID:
NCT04942366
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2021-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High-Intensity Interval Training On Women With Polycystic Ovary Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}, {'id': 'D055070', 'term': 'Resistance 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'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mubarrar@gmail.com', 'phone': '03343088915', 'title': 'Mubarra Rao', 'organization': 'Ziauddin University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'HIIT Group', 'description': 'High intensity interval training will be performed thrice a week using a treadmill.\n\nHigh intensity interval training: HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ST Group', 'description': 'Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum).\n\nStrength training: Strength training will be performed thrice a week, each session will consist of eight dynamic drills.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serum Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Group', 'description': 'High intensity interval training will be performed thrice a week using a treadmill.\n\nHigh intensity interval training: HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).'}, {'id': 'OG001', 'title': 'ST Group', 'description': 'Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum).\n\nStrength training: Strength training will be performed thrice a week, each session will consist of eight dynamic drills.'}], 'classes': [{'title': '0-week', 'categories': [{'measurements': [{'value': '2.54', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '2.54', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': '12-weeks', 'categories': [{'measurements': [{'value': '2.39', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '2.47', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks to 12-weeks', 'description': 'Levels of serum testosterone', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Body Fat Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Group', 'description': 'High intensity interval training will be performed thrice a week using a treadmill.\n\nHigh intensity interval training: HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).'}, {'id': 'OG001', 'title': 'ST Group', 'description': 'Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum).\n\nStrength training: Strength training will be performed thrice a week, each session will consist of eight dynamic drills.'}], 'classes': [{'title': '0-week', 'categories': [{'measurements': [{'value': '31.59', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '34.12', 'spread': '2.69', 'groupId': 'OG001'}]}]}, {'title': '12-weeks', 'categories': [{'measurements': [{'value': '29.62', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '32.48', 'spread': '2.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-week to 12-weeks', 'description': 'Using skinfold method (body caliper)', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIIT Group', 'description': 'High intensity interval training will be performed thrice a week using a treadmill.\n\nHigh intensity interval training: HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).'}, {'id': 'OG001', 'title': 'ST Group', 'description': 'Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum).\n\nStrength training: Strength training will be performed thrice a week, each session will consist of eight dynamic drills.'}], 'classes': [{'title': '0-week', 'categories': [{'measurements': [{'value': '3491.15', 'spread': '211.99', 'groupId': 'OG000'}, {'value': '3439.60', 'spread': '243.76', 'groupId': 'OG001'}]}]}, {'title': '12-weeks', 'categories': [{'measurements': [{'value': '3928.10', 'spread': '220.04', 'groupId': 'OG000'}, {'value': '3716.60', 'spread': '234.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-week to 12-weeks', 'description': 'International physical activity questionnaire', 'unitOfMeasure': 'MET-mins/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HIIT Group', 'description': 'High intensity interval training will be performed thrice a week using a treadmill.\n\nHigh intensity interval training: HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).'}, {'id': 'FG001', 'title': 'ST Group', 'description': 'Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum).\n\nStrength training: Strength training will be performed thrice a week, each session will consist of eight dynamic drills.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '5 withdrew from the study before the first session.', 'groupId': 'FG000', 'numSubjects': '25'}, {'comment': '5 withdrew from the study before the first session.', 'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '5 withdrew from the study before the first session.', 'groupId': 'FG000', 'numSubjects': '20'}, {'comment': '5 withdrew from the study before the first session.', 'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Serum testosterone was more than normal. Pre-diagnosed PCOS. Overweight or/and obese. Physical activity level (IPAQ).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HIIT Group', 'description': 'High intensity interval training will be performed thrice a week using a treadmill.\n\nHigh intensity interval training: HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).'}, {'id': 'BG001', 'title': 'ST Group', 'description': 'Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum).\n\nStrength training: Strength training will be performed thrice a week, each session will consist of eight dynamic drills.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.1', 'spread': '4.92', 'groupId': 'BG000'}, {'value': '30.5', 'spread': '4.80', 'groupId': 'BG001'}, {'value': '29.3', 'spread': '4.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Females', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': '10 participants withdrew from the study, five from each group and this is the reason why at the end of the study 40 participants were analyzed.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Serum Testosterone', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.54', 'spread': '0.07', 'groupId': 'BG000'}, {'value': '2.54', 'spread': '0.09', 'groupId': 'BG001'}, {'value': '2.54', 'spread': '0.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Five participants withdrew from the study, this is the reason why at the end of the study 20 participants were analyzed.'}, {'title': 'Body fat percentage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31.6', 'spread': '1.79', 'groupId': 'BG000'}, {'value': '34.1', 'spread': '2.70', 'groupId': 'BG001'}, {'value': '32.9', 'spread': '2.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Five participants withdrew from the study, this is the reason why at the end of the study 20 participants were analysed.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-09', 'size': 146207, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-29T07:25', 'hasProtocol': True}, {'date': '2021-03-09', 'size': 45861, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-29T07:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'While the exercise protocol will be explained to the participant and care giver however the they will be blinded regarding which is intervention group or control group and which exercise is the main interventional exercise will not be disclosed.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups in which participants are randomly allocated while both groups will perform warm up and cool down session, Group A will perform High intensity interval training and Group B will perform strength training exercises.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-18', 'studyFirstSubmitDate': '2021-06-19', 'resultsFirstSubmitDate': '2021-10-09', 'studyFirstSubmitQcDate': '2021-06-19', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-18', 'studyFirstPostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Testosterone', 'timeFrame': '0 weeks to 12-weeks', 'description': 'Levels of serum testosterone'}, {'measure': 'Body Fat Percentage', 'timeFrame': '0-week to 12-weeks', 'description': 'Using skinfold method (body caliper)'}, {'measure': 'Physical Activity', 'timeFrame': '0-week to 12-weeks', 'description': 'International physical activity questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High intensity interval training', 'Exercise', 'Polycystic Ovary Syndrome', 'Physical Therapy', 'Strength training', 'Testosterone', 'Physical activity'], 'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'This RCT is aimed towards determining the effectiveness of exercises based intervention strategy involving high intensity interval training exercises in improving serum testosterone level, body fat composition and physical activity in hopes to provide a definitive exercise regime for the ever common symptoms of pcos. It will be based on the theory that exercise helps in decreasing testosterone level that in turn decrease high androgen levels in the body, exercise further decreases body fat composition (obesity is a common cause or manifestation of pcos).', 'detailedDescription': "High intensity interval training will be performed over the course of 12 weeks and will be compared with the group performing strength training. Baseline assessments will be done before the start of the first session and post-test assessment will be done after the last session of the study.\n\nEnvelope method is used for the purpose of randomization. 50 envelopes having a title of group A and group B will be made and divided into two (25 in each group). Mutually exclusive technique will be used and the envelope once picked will not be replaced within the groups.\n\nSample size is calculated by using a previous study conducted in 2015 titled as, 'Effects of High Intensity Interval Training and Strength Training on Metabolic, Cardiovascular and Hormonal Outcomes in Women with Poly cystic Ovary Syndrome: A Pilot Study' by taking a confidence interval CI of 95%, power of test 80%, standard deviation of 6.3 and mean difference of 5.2, a sample size of 50 is calculated.\n\nFor the analysis of the data MedCalc software version 19.0.5. will be used. Descriptive statistics will be performed for the purpose of demographic information and this data will be presented in terms of frequency and percentage. Skewness and Kurtosis will be used in order to determine the normality of data. If the data is normally distributed, then for within the group analysis dependent T test will be performed. However, in case the data is not normally distributed Wilcoxon Sign Rank test will be performed. Independent T test will be performed for the comparison between the two groups."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI:\n\n 1. Overweight: 23-24.9 kg/m2.\n 2. Obese: greater than or equal to 25 kg/m2 .\n* Diagnosed and referred PCO patients to the rehabilitation unit would be selected for the study.\n* Aged 18-40.\n* High serum testosterone level: normal range 6-86 ng/dl.\n\nExclusion Criteria:\n\n* On-going pregnancy.\n* Any cardiovascular complication.\n* Any other endocrine disorder\n* Any musculoskeletal condition that hinders in performing the exercise training protocol.'}, 'identificationModule': {'nctId': 'NCT04942366', 'briefTitle': 'High-Intensity Interval Training On Women With Polycystic Ovary Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'Ziauddin University'}, 'officialTitle': 'Effects of High-Intensity Interval Training and Strength Training On Levels of Testosterone and Physical Activity Among Women With Polycystic Ovary Syndrome.', 'orgStudyIdInfo': {'id': 'Mubarra Rao'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIIT Group', 'description': 'High intensity interval training will be performed thrice a week using a treadmill.', 'interventionNames': ['Other: High intensity interval training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ST Group', 'description': 'Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum).', 'interventionNames': ['Other: Strength training']}], 'interventions': [{'name': 'High intensity interval training', 'type': 'OTHER', 'otherNames': ['HIIT'], 'description': 'HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).', 'armGroupLabels': ['HIIT Group']}, {'name': 'Strength training', 'type': 'OTHER', 'description': 'Strength training will be performed thrice a week, each session will consist of eight dynamic drills.', 'armGroupLabels': ['ST Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75340', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Shamim clinic', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Mubarra Rao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziauddin University'}, {'name': 'Amna Amir Khan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ziauddin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziauddin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mubarra Rao', 'investigatorAffiliation': 'Ziauddin University'}}}}