Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-01-02 @ 12:31 PM
Study NCT ID:
NCT07156266
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2025-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effects of Kegal vs Squat Exercises on Urinary Incontinence Severity and Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary incontinence', 'timeFrame': '12 weeks', 'description': 'The International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms Long Form (ICIQ-FLUTS-LF) will be used to assess the severity of urinary incontinence.'}], 'secondaryOutcomes': [{'measure': 'The Incontinence Quality of Life', 'timeFrame': '12 Weeks', 'description': 'The Incontinence Quality of Life questionnaire (I-QOL) will be used to assess the quality of life in patients with urinary incontinence.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'A randomized clinical trial will be carried out to compare the effectiveness of Kegel and squat exercises in reducing urinary incontinence. The study will include 30 participants diagnosed with urinary incontinence, who will be randomly assigned to either a Kegel exercise group or a squat exercise group. Both groups will perform their respective exercises for 10 minutes, three times daily, over a period of 12 weeks. Outcomes will be assessed using the International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms Long Form (ICIQ-FLUTS LF) and the Incontinence Quality of Life (I-QOL) questionnaire'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Women aged between 30 and 60 years with a confirmed diagnosis of urinary incontinence (UI) by a qualified healthcare professional.\n\nWomen who are physically able to perform the required exercises and are willing to provide informed consent to participate in the study.\n\nExclusion Criteria\n\nPregnant women or those planning to become pregnant during the study period. Individuals who have undergone surgery within the past six months that may affect pelvic floor strength or urinary incontinence symptoms.\n\nWomen with neurological disorders, current urinary tract infections (UTIs), or a history of recurrent UTIs that could influence pelvic floor function or UI symptoms.'}, 'identificationModule': {'nctId': 'NCT07156266', 'briefTitle': 'Comparative Effects of Kegal vs Squat Exercises on Urinary Incontinence Severity and Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'University of Faisalabad'}, 'officialTitle': 'Comparative Effects of Kegal and Squat Exercises on Urinary Incontinence Severity and Quality of Life', 'orgStudyIdInfo': {'id': 'TUF/PB/45/1038/45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (Kegal Exercise Group)', 'interventionNames': ['Procedure: Kegal Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (Squats Exercise Group)', 'interventionNames': ['Procedure: Squats Exercise']}], 'interventions': [{'name': 'Kegal Exercise', 'type': 'PROCEDURE', 'description': 'Dead Bugs:Participants will begin by lying on their backs with their arms extended overhead and legs bent at a 90-degree angle. While engaging their core muscles, they will gradually lower their arms and legs toward the floor, then return to the starting position.\n\nBridging Exercise: Lying on their backs with knees bent and feet flat on the ground, participants will gently raise their hips upward while activating the pelvic floor muscles, then slowly lower them back to the starting position.', 'armGroupLabels': ['Group A (Kegal Exercise Group)']}, {'name': 'Squats Exercise', 'type': 'PROCEDURE', 'description': 'Sumo Squats: Participants will stand with their feet placed wider than shoulder-width apart and toes pointing outward. They will then squat down, keeping their backs straight and their weight on their heels, pause briefly at the bottom, and return to a standing position.\n\nNarrow Squats: With their feet set shoulder-width apart and toes pointing forward or slightly outward, participants will lower their bodies into a squat position while keeping their backs straight and their weight centered in the heels. After a brief pause, they will return to a standing position.', 'armGroupLabels': ['Group B (Squats Exercise Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Faisalābad', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'University of Faisalabad'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Faisalabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Dr Izza Ayub; PT', 'investigatorAffiliation': 'University of Faisalabad'}}}}