Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-28 @ 2:50 AM
Study NCT ID:
NCT04530266
Status:
UNKNOWN
Last Update Posted:
2020-08-28
First Post:
2020-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability of Measuring Walking-related Performance Fatigability Using Six Minute Walk Test in Persons With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000070857', 'term': 'Walk Test'}], 'ancestors': [{'id': 'D005080', 'term': 'Exercise Test'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-27', 'studyFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2020-08-27', 'lastUpdatePostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of walking related performance fatigability using six minute walk test', 'timeFrame': 'Day 1'}, {'measure': 'Assessment of walking related performance fatigability using six minute walk test', 'timeFrame': 'Day 2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoarthritis', 'six minute walk test', 'reliability', 'fatigue', 'fatigability'], 'conditions': ['Osteoarthritis', 'Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'Evidence has shown that knee osteoarthritis causes an increase in base of support and a decrease in stride length and gait velocity which results in an increase in energy expenditure during walking. This increase in energy cost of walking is suggested to result in walking related performance fatigability. However, fatigue is not commonly considered in the clinical settings in term of neither assessment nor management of knee osteoarthritis. One common tool used to evaluate walking relate performance is six minute walk test and the purpose of this study is to determine the reliability of using six minute walk test to determine walking related performance fatigability in persons with knee osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40-70 years\n* Knee OA with history not less than three months.\n* Radiological evidences of grade III or less on Kellgren classification.\n* Knee pain on VNRS no more than 8/10.\n\nExclusion Criteria:\n\n* Neuromuscular conditions that may lead to fatigue such as multiple Sclerosis\n* Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection).\n* History of trauma or fractures in lower extremity.\n* Signs of lumbar radiculopathy or myelopathy.\n* History of knee surgery or replacement.\n* Patients on intra-articular steroid therapy within two months before the commencement of the study.\n* Impaired skin sensation and renal function.'}, 'identificationModule': {'nctId': 'NCT04530266', 'briefTitle': 'Reliability of Measuring Walking-related Performance Fatigability Using Six Minute Walk Test in Persons With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Foundation University Islamabad'}, 'officialTitle': 'Reliability of Measuring Walking-related Performance Fatigability Using Six Minute Walk Test in Persons With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'FUI/CTR/2020/6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Persons with knee osteoarthritis', 'interventionNames': ['Diagnostic Test: Six minute walk test']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Healthy controls', 'interventionNames': ['Diagnostic Test: Six minute walk test']}], 'interventions': [{'name': 'Six minute walk test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment of walking related performance fatigability using six minute walk test', 'armGroupLabels': ['Healthy controls', 'Persons with knee osteoarthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Islamabad', 'state': 'Federal', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Muhammad Osama, PhD*', 'role': 'CONTACT', 'email': 'osamadpt@gmail.com', 'phone': '03325540436'}], 'facility': 'Foundation University Institute of Rehabilitation Sciences.', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'centralContacts': [{'name': 'Muhammad Osama, PhD*', 'role': 'CONTACT', 'email': 'osamadpt@gmail.com', 'phone': '03325540436'}], 'overallOfficials': [{'name': 'Muhammad Osama, PhD*', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Foundation University Islamabad'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation University Islamabad', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hasselt University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}