Ignite Creation Date:
2025-12-24 @ 3:39 PM
Ignite Modification Date:
2025-12-24 @ 3:39 PM
Study NCT ID:
NCT06707792
Status:
RECRUITING
Last Update Posted:
2024-12-02
First Post:
2024-11-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validity and Reliability of 6 Minute Stepper Test in Kidney Transplant Recipients
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': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2024-11-25', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise capacity', 'timeFrame': 'Day 1', 'description': 'Exercise capacity will be assessed with a 6 minute stepper test.'}, {'measure': 'Exercise capacity', 'timeFrame': 'Day 1', 'description': 'Exercise capacity will be assessed with a 6 minute walk test.'}, {'measure': 'Peripheral muscle strength', 'timeFrame': 'Day 1', 'description': 'Knee extensor strength will be measured using a portable portable handheld dynamometer.'}, {'measure': 'Lower extremity endurance', 'timeFrame': 'Day 1', 'description': 'It will be evaluated with a one-minute sit to stand test.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Transplanted Recipients']}, 'descriptionModule': {'briefSummary': 'The aim of our study was to investigate the validity and reliability of the 6 minute stepper test in kidney transplant recipients.'}, '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': 'NCT06707792', 'briefTitle': 'Validity and Reliability of 6 Minute Stepper Test in Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Investigation of Validity and Reliability of 6 Minute Stepper Test in Kidney Transplant Recipients', 'orgStudyIdInfo': {'id': 'GO 23/604'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Kidney transplant recipients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Naciye Vardar-Yagli, Assistant Professor', 'role': 'CONTACT', 'email': 'naciyevardar@yahoo.com'}], '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': '+903123051576'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Merve Firat', 'investigatorAffiliation': 'Kirsehir Ahi Evran Universitesi'}}}}