Clinical trial NCT03977961: The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.
Official title: The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Disc Disease
Lumbar Spine Degeneration
Lumbar Spinal Stenosis
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
Collaborators: name: Prof. Dr. Astrid Weyerbrock, Klinik für Neurochirurgie, Kantonsspital St. Gallen
name: PD Dr. med. Martin Stienen, Klinik für Neurochirurgie, Universitätsspital Zürich
name: Dr. med. Peter Prömmel, Klinik für Neurochirurgie, Kantonsspital St. Gallen
name: PD Dr. med. Oliver Gautschi, Neuro- und Wirbelsäulen Zentrum Zentral-schweiz, Luzern
name: med. pract. Markéta Sosnová, Klinik für Neurochirurgie, Kantonsspital St. Gallen
First posted: 2019-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: The study determines the reliability and validity of the 6-Minute Walking Test (6MWT) in patients with lumbar degenerative disc disease (DDD).

Detailed description: 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.

Primary 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)

Secondary objectives are

1. to correlate objective functional impairment (OFI) with already established patient-rated outcome measures (PROMs) in the sense of cross-validation.
2. To correlate OFI, as determined by the 6MWT with OFI that is determined by another objective test, the TUG test
3. to then analyze the change in OFI in patients before and after surgical intervention
4. to determine whether patients prefer the objective (6MWT) or subjective (PROMs) repeated assessment of their functional condition.

Eligibility criteria: Inclusion Criteria:

* 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)
* Male and Female subjects ≥ 18 years
* Written informed consent

Exclusion Criteria:

* Pregnancy
* Inability to walk (extreme pain or severe neurological deficits)
* Severe Chronic Obstructive Lung Disease (COPD) corresponding to ≥ Gold III
* Severe heart failure corresponding to ≥ New York Heart Association (NYHA) III
* Lung cancer and diffuse parenchymal lung disease
* 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.)
* Unavailability for follow up and/or inability to complete assessment (planning to move, no smartphone, etc.).

Primary outcomes:
measure: Raw walking distance
timeFrame: 4-12 weeks
Secondary outcomes:
measure: TTFS
timeFrame: 4-12 weeks
measure: DTFS
timeFrame: 4-12 weeks
measure: Zurich Claudication Questionnaire (ZCQ)
timeFrame: 4-12 weeks
measure: Core Outcome Measures Index (COMI)
timeFrame: 4-12 weeks
measure: TTFS/ZCQ baseline
timeFrame: 4-12 weeks
measure: TTFS/ZCQ follow-up
timeFrame: 4-12 weeks
measure: TTFS/COMI baseline
timeFrame: 4-12 weeks
measure: TTFS/COMI follow-up
timeFrame: 4-12 weeks
measure: TTFS/TUG baseline
timeFrame: 4-12 weeks
measure: TTFS/TUG follow-up
timeFrame: 4-12 weeks
measure: Test-retest reliability of the 6MWT
timeFrame: 6 weeks to 1 day before surgery as well as 4-12 weeks after surgery
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen / Department of Neurosurgery
state: Saint Gallen
Study officials:
affiliation: Department of Neurosurgery
name: Nicolai Maldaner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.