Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-08 @ 4:47 AM
Study NCT ID:
NCT05313360
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2022-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Sarcopenia and Urinary Incontinence And Effect Of Physical Activity Among Over 50 Years Old Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D055948', 'term': 'Sarcopenia'}], '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'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2022-01-06', 'studyFirstSubmitQcDate': '2022-03-28', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sarcopenia and urinary incontinence', 'timeFrame': 'Day 1', 'description': 'Investigate the associations between sarcopenia and urinary incontinence among older adults (≥ 50 years).'}, {'measure': 'Physical activity level effect', 'timeFrame': 'Day 1', 'description': 'Identify the effect of Physical activity level on the occurrence of Sarcopenia and Urinary incontinence.'}], 'secondaryOutcomes': [{'measure': 'Prevalence of Sarcopenia and Urinary incontinence', 'timeFrame': 'Day 1', 'description': 'To determine the prevalence of sarcopenia and UI among elderly individuals in Hungary'}, {'measure': 'insights into physical activity levels', 'timeFrame': 'Day 1', 'description': 'Explore and study physical activity levels among aging adults of both sexes in Hungary'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urinary Incontinence', 'Sarcopenia'], 'conditions': ['Urinary Incontinence', 'Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '40715321', 'type': 'DERIVED', 'citation': 'Debes WA, Sadaqa M, Acs P, Kovacs K, Premusz V, Hock M. Sarcopenia risk as a predictor of urinary incontinence in women aged 50 and older: a cross-sectional analysis. Sci Rep. 2025 Jul 26;15(1):27288. doi: 10.1038/s41598-025-11963-2.'}]}, 'descriptionModule': {'briefSummary': 'As far as the investigators know, until this moment no research has investigated the prevalence of Sarcopenia in both sexes in Hungary. Additionally, no research discovered the association between sarcopenia and UI and the effect of physical activity level on these geriatric conditions in Hungary.\n\nFurthermore, it is known that Sarcopenia and UI are causing negative psychological, physical, and social effects on the geriatrics who are suffering from these conditions, not to mention the increase in health care costs. In an attempt to decrease these negative effects, there is a need for a deeper understanding of these conditions by identifying the relationship between them and understanding the risk factors that might cause them. The finding of this study would help with determining those risk factors that are causing these geriatric conditions (Sarcopenia and UI).\n\nLast, this study will provide accurate numbers and statistics to the Hungarian health organizations and educational institutions about the prevalence of sarcopenia and UI which will help shed the light on the importance of these problems among older adults in Hungary.\n\nThis Cross-sectional study aim to:\n\n1. Explore and study physical activity levels among aging adults of both sexes in Hungary.\n2. To determine the prevalence of sarcopenia and UI among elderly individuals in Hungary.\n3. Investigate the associations between sarcopenia and urinary incontinence among older adults (≥ 50 years).\n4. Identify the effect of physical activity level on the occurrence of Sarcopenia and Urinary incontinence\n\nHypothesis:\n\n1. The investigators hypothesize that sarcopenia is a risk factor to have UI.\n2. The investigators hypothesize that reduced physical activity level is also associated with sarcopenia and/or UI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is any participant who is 50 years or older, and living in the South Danubia region, in Hungary.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Any person who is 50 years old or older\n\nExclusion Criteria:\n\n• Individuals who cannot provide reliable clinical information due to cognitive disorders.\n\nIndividuals who are having any neurodegenerative disorders (E.g; Parkinson).'}, 'identificationModule': {'nctId': 'NCT05313360', 'briefTitle': 'Association Between Sarcopenia and Urinary Incontinence And Effect Of Physical Activity Among Over 50 Years Old Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'The Association Between Sarcopenia and Urinary Incontinence and the Effect of Physical Activity Among Over 50 Years Old Adults in South-Danubia', 'orgStudyIdInfo': {'id': '9080 - PTE 2021'}}, 'contactsLocationsModule': {'locations': [{'city': 'Pécs', 'country': 'Hungary', 'facility': 'University of Pécs', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pecs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}