Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-27 @ 11:04 PM
Study NCT ID:
NCT07028034
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2025-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The 6 Minute Step Test in Chronic Low Back Pain
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': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional capacity', 'timeFrame': '1st and 2nd day', 'description': 'Functional capacity will be assessed with a 6 minute walk test and 6 minute step test, and total distance and total number of step will be recorded. Quadriceps muscle oxygenation will be assessed with a monitor during the tests.'}, {'measure': 'Muscle function', 'timeFrame': '1st day', 'description': 'will be evaluated with a 5 times sit to stand test and the total time recorded.'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '1st day', 'description': 'Hand grip and quadriceps femoris muscle strength will be evaluated with a dynamometer'}, {'measure': 'Disability level', 'timeFrame': '1st day', 'description': 'It will be assessed with Oswestry Disability Index. High scores (0-50 point) on the scale indicate the presence and severity of symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Our study aimed to investigate whether the 6 minute step test could be used as an alternative to the 6 minute walk test for assessing functional capacity in individuals with chronic low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with chronic low back pain will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with chronic low back pain\n* Chronic low back pain for at least the last 3 months\n* Being aged 18-65\n* Voluntary participation in the study\n\nExclusion Criteria:\n\n* Having orthopedic or neurological impairments\n* History of surgery due to chronic low back pain in the last 6 months\n* Being pregnant\n* Participating in regular physical activity in the past 3 months'}, 'identificationModule': {'nctId': 'NCT07028034', 'briefTitle': 'The 6 Minute Step Test in Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Kirsehir Ahi Evran Universitesi'}, 'officialTitle': 'Could the 6 Minute Step Test be Used Instead of the 6 Minute Walk Test to Assess Functional Capacity in Individuals With Chronic Low Back Pain?', 'orgStudyIdInfo': {'id': '2025-08/89'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Indıviduals with chronic low back pain'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kırşehir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Merve Firat', 'role': 'CONTACT', 'email': 'mervefirat@ahievran.edu.tr', 'phone': '+90 850 441 02 44', 'phoneExt': '2490'}], 'facility': 'Kirsehir Ahi Evran University', 'geoPoint': {'lat': 39.14583, 'lon': 34.16389}}], 'centralContacts': [{'name': 'Merve Firat', 'role': 'CONTACT', 'email': 'mervefirat@ahievran.edu.tr', 'phone': '+90 850 441 02 44', 'phoneExt': '2490'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirsehir Ahi Evran Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Merve Firat', 'investigatorAffiliation': 'Kirsehir Ahi Evran Universitesi'}}}}