Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-01-01 @ 1:04 PM
Study NCT ID:
NCT05202535
Status:
COMPLETED
Last Update Posted:
2022-09-16
First Post:
2022-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Aerobic Exercise Training in Obese Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2022-01-08', 'studyFirstSubmitQcDate': '2022-01-08', 'lastUpdatePostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arterial Stiffness', 'timeFrame': '6 weeks', 'description': 'Gradual fragmentation and loss of elastin fibers and accumulation of stiffer collagen fibers in the arterial wall. Calculated through Arterial stiffness index.'}, {'measure': 'Hemodynamics', 'timeFrame': '6 weeks', 'description': 'Factors that govern blood flow calculated through Rate Pressure Product.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aerobic exercise, arterial stiffness, hemodynamics, obesity'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '25748874', 'type': 'BACKGROUND', 'citation': 'Hvidt KN. Blood pressure and arterial stiffness in obese children and adolescents. Dan Med J. 2015 Mar;62(3):B5043.'}, {'pmid': '25633314', 'type': 'BACKGROUND', 'citation': 'Cote AT, Phillips AA, Harris KC, Sandor GG, Panagiotopoulos C, Devlin AM. Obesity and arterial stiffness in children: systematic review and meta-analysis. Arterioscler Thromb Vasc Biol. 2015 Apr;35(4):1038-44. doi: 10.1161/ATVBAHA.114.305062. Epub 2015 Jan 29.'}]}, 'descriptionModule': {'briefSummary': 'To determine the effect of aerobic exercise training on arterial stiffness and hemodynamics in obese adults. Proper evidence on the effect of aerobic exercise training on both arterial stiffness and hemodynamics are sparsely present in obese adults whereas separate studies were done in mainly hypertensive and cardiovascular disease populations.', 'detailedDescription': 'Obese adults always have been trying to improve their quality of life by managing the complications associated with obesity like arterial stiffness and disturbed hemodynamics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index ≥28 kg/m²\n* Able to do exercise\n\nExclusion Criteria:\n\n* Involved in structured physical activity in last 6 months\n* History of chronic systemic disease (cardiovascular, pulmonary, and metabolic disease)\n* Continuous medication use.\n* MSK or Neurological problems\n* Pregnant females'}, 'identificationModule': {'nctId': 'NCT05202535', 'briefTitle': 'Effect of Aerobic Exercise Training in Obese Adults', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effect of Aerobic Exercise Training on Arterial Stiffness and Hemodynamics in Obese Adults.', 'orgStudyIdInfo': {'id': 'REC/01092 Khowla shah'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic exercise training', 'description': 'hospital-based aerobic exercise training on treadmill/cycle ergometer with the intensity of 40-70% of HR max, for 15-30 mints for 8 weeks', 'interventionNames': ['Other: Aerobic exercise training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional therapy', 'description': 'Patient education and counseling with diet plan.Walking 3 days15min/day for 8 weeks', 'interventionNames': ['Other: Conventional therapy']}], 'interventions': [{'name': 'Aerobic exercise training', 'type': 'OTHER', 'description': 'Hospital-based aerobic exercise training for 15-30 minutes including pre and post-vitals assessment.\n\n3x/week on alternate days for 8 weeks at 40-70% of HR Max', 'armGroupLabels': ['Aerobic exercise training']}, {'name': 'Conventional therapy', 'type': 'OTHER', 'description': 'Patient education and counseling with diet plan.Walking 3 days15min/day for 8 weeks', 'armGroupLabels': ['Conventional therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04404', 'city': 'Islamabad', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Polyclinic Hospital', 'geoPoint': {'lat': 29.7426, 'lon': 73.14353}}], 'overallOfficials': [{'name': 'Mehwish Waseem, MSPT(CPPT)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}