Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-03-03 @ 2:07 PM
Study NCT ID:
NCT03977961
Status:
COMPLETED
Last Update Posted:
2022-07-26
First Post:
2019-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535531', 'term': 'Intervertebral disc disease'}, {'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-22', 'studyFirstSubmitDate': '2019-05-31', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Raw walking distance', 'timeFrame': '4-12 weeks', 'description': 'Raw walking distance (in m), as measured with the 6MWT, between the baseline- (before surgery) and follow-up assessment'}], 'secondaryOutcomes': [{'measure': 'TTFS', 'timeFrame': '4-12 weeks', 'description': 'Difference in Time to First Symptoms (TTFS; in sec) as measured by the 6MWT, between the baseline- and follow-up assessment'}, {'measure': 'DTFS', 'timeFrame': '4-12 weeks', 'description': 'Difference in Distance to First Symptoms (DTFS, in m), as measured by the 6MWT, between the baseline- and follow-up assessment'}, {'measure': 'Zurich Claudication Questionnaire (ZCQ)', 'timeFrame': '4-12 weeks', 'description': 'Difference in PROM, as measured by the Zurich Claudication Questionnaire (ZCQ average score, range 0 (best) - 4,5 (worst), between the baseline- and follow-up assessment.'}, {'measure': 'Core Outcome Measures Index (COMI)', 'timeFrame': '4-12 weeks', 'description': 'Difference in health-related quality of life (hrQoL), as measured by the Core Outcome Measures Index (COMI average score, range 0 (best) - 10 (worst)), between the baseline- and follow-up assessment'}, {'measure': 'TTFS/ZCQ baseline', 'timeFrame': '4-12 weeks', 'description': 'Correlation of TTFS/DTFS in the 6MWT with the ZCQ score at baseline'}, {'measure': 'TTFS/ZCQ follow-up', 'timeFrame': '4-12 weeks', 'description': 'Correlation of TTFS in the 6MWT with the ZCQ score at follow-up'}, {'measure': 'TTFS/COMI baseline', 'timeFrame': '4-12 weeks', 'description': 'Correlation of TTFS/DTFS in the 6MWT with the COMI score at baseline'}, {'measure': 'TTFS/COMI follow-up', 'timeFrame': '4-12 weeks', 'description': 'Correlation of TTFS/DTFS in the 6MWT with the COMI score at follow-up'}, {'measure': 'TTFS/TUG baseline', 'timeFrame': '4-12 weeks', 'description': 'Correlation of TTFS/DTFS in the 6MWT with the Timed up go Test (TUG) at baseline'}, {'measure': 'TTFS/TUG follow-up', 'timeFrame': '4-12 weeks', 'description': 'Correlation of TTFS/DTFS in the 6MWT with the TUG at follow-up'}, {'measure': 'Test-retest reliability of the 6MWT', 'timeFrame': '6 weeks to 1 day before surgery as well as 4-12 weeks after surgery', 'description': 'Test-retest reliability of the 6MWT in patients with lumbar degenerate disc disease, tested two consecutive times with the 6MWT App (within 3 days) before as well as after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Disc Disease', 'Lumbar Spine Degeneration', 'Lumbar Spinal Stenosis']}, 'referencesModule': {'references': [{'pmid': '37182704', 'type': 'DERIVED', 'citation': 'Ziga M, Sosnova M, Zeitlberger AM, Regli L, Bozinov O, Weyerbrock A, Ratliff JK, Stienen MN, Maldaner N. Objective outcome measures may demonstrate continued change in functional recovery in patients with ceiling effects of subjective patient-reported outcome measures after surgery for lumbar degenerative disorders. Spine J. 2023 Sep;23(9):1314-1322. doi: 10.1016/j.spinee.2023.05.002. Epub 2023 May 13.'}, {'pmid': '35015137', 'type': 'DERIVED', 'citation': 'Zeitlberger AM, Sosnova M, Ziga M, Gautschi OP, Regli L, Bozinov O, Weyerbrock A, Stienen MN, Maldaner N. Distance to first symptoms measured by the 6-min walking test differentiates between treatment success and failure in patients with degenerative lumbar disorders. Eur Spine J. 2022 Mar;31(3):596-603. doi: 10.1007/s00586-021-07103-9. Epub 2022 Jan 11.'}, {'pmid': '34042414', 'type': 'DERIVED', 'citation': 'Zeitlberger AM, Sosnova M, Ziga M, Regli L, Bozinov O, Weyerbrock A, Stienen MN, Maldaner N. Assessment of the Minimum Clinically Important Difference in the Smartphone-based 6-minute Walking Test After Surgery for Lumbar Degenerative Disc Disease. Spine (Phila Pa 1976). 2021 Sep 15;46(18):E959-E965. doi: 10.1097/BRS.0000000000003991.'}, {'pmid': '34033596', 'type': 'DERIVED', 'citation': 'Maldaner N, Sosnova M, Ziga M, Zeitlberger AM, Bozinov O, Gautschi OP, Weyerbrock A, Regli L, Stienen MN. External Validation of the Minimum Clinically Important Difference in the Timed-up-and-go Test After Surgery for Lumbar Degenerative Disc Disease. Spine (Phila Pa 1976). 2022 Feb 15;47(4):337-342. doi: 10.1097/BRS.0000000000004128.'}, {'pmid': '33974372', 'type': 'DERIVED', 'citation': 'Maldaner N, Sosnova M, Zeitlberger AM, Ziga M, Gautschi OP, Regli L, Bozinov O, Weyerbrock A, Stienen MN. Responsiveness of the self-measured 6-minute walking test and the Timed Up and Go test in patients with degenerative lumbar disorders. J Neurosurg Spine. 2021 May 7;35(1):52-59. doi: 10.3171/2020.11.SPINE201621. Epub 2021 May 7.'}]}, 'descriptionModule': {'briefSummary': 'The study determines the reliability and validity of the 6-Minute Walking Test (6MWT) in patients with lumbar degenerative disc disease (DDD).', 'detailedDescription': 'The purposes of the study is to assess the ability of the 6-Minute Walking Test (6MWT) as a reliable and standardized objective outcome assessment and its relation to already established subjective patient reported outcome measures in patients suffering from lumbar degenerative disc disease. We want to use an existing smartphone-application that uses global positioning system (GPS) coordinates to measure walking distance. Applying self- measurement of the 6MWT before and after a therapeutic intervention, we determine objective functional impairment (OFI) in patients. The results of this study add to the understanding of achievable objective outcomes after therapeutic interventions applied to patients with DDD and examines patients acceptance for smartphone based self-measurement.\n\nPrimary Objectives The primary objective is to determine the reliability and validity of the 6-Minute Walking Test (6MWT) in patients with lumbar degenerative disc disease (DDD)\n\nSecondary objectives are\n\n1. to correlate objective functional impairment (OFI) with already established patient-rated outcome measures (PROMs) in the sense of cross-validation.\n2. To correlate OFI, as determined by the 6MWT with OFI that is determined by another objective test, the TUG test\n3. to then analyze the change in OFI in patients before and after surgical intervention\n4. to determine whether patients prefer the objective (6MWT) or subjective (PROMs) repeated assessment of their functional condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients presenting to the neurosurgical department of the Kantonsspital St. Gallen (KSSG) with a diagnosed DDD fulfilling the inclusion criteria and scheduled for surgery will be considered for this study.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient scheduled for spine surgery with one of the following diagnosis (1) lumbar disc herniation (LDH), (2) lumbar spinal stenosis lumbar (LSS) or lumbar DDD with or without instability requiring lumbar fusion (transforaminal lumbar interbody fusion, posterior lumbar interbody fusion, or extreme lateral interbody fusion)\n* Male and Female subjects ≥ 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Inability to walk (extreme pain or severe neurological deficits)\n* Severe Chronic Obstructive Lung Disease (COPD) corresponding to ≥ Gold III\n* Severe heart failure corresponding to ≥ New York Heart Association (NYHA) III\n* Lung cancer and diffuse parenchymal lung disease\n* Other medical reasons interfering with the patient's ability to walk and perform the 6MWT (e.g., osteoarthritis disease of the lower extremities, Parkinson's disease, heart failure, hip or knee prosthesis etc.)\n* Unavailability for follow up and/or inability to complete assessment (planning to move, no smartphone, etc.)."}, 'identificationModule': {'nctId': 'NCT03977961', 'acronym': '6MWT-DDD', 'briefTitle': 'The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hospital of St. Gallen'}, 'officialTitle': 'The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.', 'orgStudyIdInfo': {'id': '6MWT DDD - 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DDD Patients', 'description': 'All patients presenting to the neurosurgical department of the Kantonsspital St. Gallen (KSSG) with a diagnosed DDD fulfilling the inclusion criteria and scheduled for surgery will be considered for this study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Sankt Gallen', 'state': 'Canton of St. Gallen', 'country': 'Switzerland', 'facility': 'Kantonsspital St. Gallen / Department of Neurosurgery', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}], 'overallOfficials': [{'name': 'Nicolai Maldaner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurosurgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cantonal Hospital of St. Gallen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prof. Dr. Astrid Weyerbrock, Klinik für Neurochirurgie, Kantonsspital St. Gallen', 'class': 'UNKNOWN'}, {'name': 'PD Dr. med. Martin Stienen, Klinik für Neurochirurgie, Universitätsspital Zürich', 'class': 'UNKNOWN'}, {'name': 'Dr. med. Peter Prömmel, Klinik für Neurochirurgie, Kantonsspital St. Gallen', 'class': 'UNKNOWN'}, {'name': 'PD Dr. med. Oliver Gautschi, Neuro- und Wirbelsäulen Zentrum Zentral-schweiz, Luzern', 'class': 'UNKNOWN'}, {'name': 'med. pract. Markéta Sosnová, Klinik für Neurochirurgie, Kantonsspital St. Gallen', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nicolai Maldaner', 'investigatorAffiliation': 'Cantonal Hospital of St. Gallen'}}}}