Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 1:37 PM
Study NCT ID:
NCT06706492
Status:
RECRUITING
Last Update Posted:
2024-11-26
First Post:
2024-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Muscle Oxygenation, Functional Capacity and Frailty in Kidney Transplant Recipients with and Without Inspiratory Muscle Weakness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2024-11-19', 'studyFirstSubmitQcDate': '2024-11-22', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory muscle strength', 'timeFrame': '1st day', 'description': 'Maximal inspiratory pressure (MIP) will be measured using a portable mouth pressure measuring device.'}, {'measure': 'Respiratory muscle strength', 'timeFrame': '1st day', 'description': 'Maximal expiratory pressure (MEP) will be measured using a portable mouth pressure measuring device.'}, {'measure': 'Functional capacity', 'timeFrame': '1st day', 'description': 'Will be evaluated with 6 minute walk test.'}, {'measure': 'Peripheral muscle strength', 'timeFrame': '1st day', 'description': 'Knee extensor strength will be measured using a hand dynamometer.'}, {'measure': 'Peripheral muscle strength', 'timeFrame': '1st day', 'description': 'Hand grip strength will be measured using grip dynamometer.'}], 'secondaryOutcomes': [{'measure': 'Forced expiratory volume in one second', 'timeFrame': '1st day', 'description': 'Respiratory function will be evaluated using spirometry. Forced expiratory volume in one second will be recorded.'}, {'measure': 'Forced vital capacity', 'timeFrame': '1st day', 'description': 'Respiratory function will be evaluated using spirometry. Forced vital capacity will be recorded.'}, {'measure': 'Forced expiratory volume in one second/forced vital capacity', 'timeFrame': '1st day', 'description': 'Respiratory function will be evaluated using spirometry. Forced expiratory volume in one second/forced vital capacity will be recorded.'}, {'measure': 'Peak expiratory flow', 'timeFrame': '1st day', 'description': 'Respiratory function will be evaluated using spirometry. Peak expiratory flow will be recorded.'}, {'measure': 'Forced mid-expiratory flow', 'timeFrame': '1st day', 'description': 'Respiratory function will be evaluated using spirometry. Forced mid-expiratory flow (FEF25-75) will be recorded.'}, {'measure': 'Body composition', 'timeFrame': '1st day', 'description': 'It will be evaluated by bioelectrical impedance analysis method. Percentage of fat and lean body mass wiil be recorded.'}, {'measure': 'Fragility', 'timeFrame': '1st day', 'description': 'It will be assessed according to the criteria defined by Fried. The existence of 5 parameters is questioned here. These parameters are as follows: weight loss, weakness, fatigue, slowness, low physical activity. Those with 3 or more of the 5 identified components are classified as fragile.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Transplantation']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare respiratory function, muscle oxygenation, functional capacity, peripheral muscle strength, body composition, and frailty in kidney transplant recipients with and without inspiratory muscle weakness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Kidney transplant recipients will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with kidney transplantation\n* At least 6 months after the kidney transplant\n* Not having regular exercise habits\n* Voluntary participation in the study\n\nExclusion Criteria:\n\n* Having a musculoskeletal problem that may interfere with the tests\n* Having neurological impairment\n* Having chronic lung disease\n* Having had any cardiovascular event in the last 6 months'}, 'identificationModule': {'nctId': 'NCT06706492', 'briefTitle': 'Muscle Oxygenation, Functional Capacity and Frailty in Kidney Transplant Recipients with and Without Inspiratory Muscle Weakness', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Comparison of Muscle Oxygenation, Functional Capacity, and Frailty in Kidney Transplant Recipients with and Without Inspiratory Muscle Weakness', 'orgStudyIdInfo': {'id': 'SBA 23/286'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with inspiratory muscle weakness'}, {'label': 'Patients without inspiratory muscle weakness'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Naciye Vardar-Yagli', 'role': 'CONTACT', 'email': 'naciyevardar@yahoo.com', 'phone': '+90 312 305 15 76', 'phoneExt': '123'}], 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Merve Firat', 'role': 'CONTACT', 'email': 'mervefirat@ahievran.edu.tr', 'phone': '+90 850 441 02 44'}, {'name': 'Naciye Vardar-Yagli', 'role': 'CONTACT', 'email': 'naciyevardar@yahoo.com', 'phone': '+90 312 305 15 76', 'phoneExt': '123'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Merve Firat', 'investigatorAffiliation': 'Kirsehir Ahi Evran Universitesi'}}}}