The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease. (6MWT-DDD)

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

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis; Lumbar Disc Disease; Lumbar Spine Degeneration

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Switzerland
  • Saint Gallen
    • St. Gallen, Saint Gallen, Switzerland, 9000
      • Kantonsspital St. Gallen / Department of Neurosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
DDD Patients; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Raw walking distance	Raw walking distance (in m), as measured with the 6MWT, between the baseline- (before surgery) and follow-up assessment	4-12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TTFS	Difference in Time to First Symptoms (TTFS; in sec) as measured by the 6MWT, between the baseline- and follow-up assessment	4-12 weeks
DTFS	Difference in Distance to First Symptoms (DTFS, in m), as measured by the 6MWT, between the baseline- and follow-up assessment	4-12 weeks
Zurich Claudication Questionnaire (ZCQ)	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.	4-12 weeks
Core Outcome Measures Index (COMI)	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	4-12 weeks
TTFS/ZCQ baseline	Correlation of TTFS/DTFS in the 6MWT with the ZCQ score at baseline	4-12 weeks
TTFS/ZCQ follow-up	Correlation of TTFS in the 6MWT with the ZCQ score at follow-up	4-12 weeks
TTFS/COMI baseline	Correlation of TTFS/DTFS in the 6MWT with the COMI score at baseline	4-12 weeks
TTFS/COMI follow-up	Correlation of TTFS/DTFS in the 6MWT with the COMI score at follow-up	4-12 weeks
TTFS/TUG baseline	Correlation of TTFS/DTFS in the 6MWT with the Timed up go Test (TUG) at baseline	4-12 weeks
TTFS/TUG follow-up	Correlation of TTFS/DTFS in the 6MWT with the TUG at follow-up	4-12 weeks
Test-retest reliability of the 6MWT	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.	6 weeks to 1 day before surgery as well as 4-12 weeks after surgery

Collaborators and Investigators

• Sponsor: Cantonal Hospital of St. Gallen
• Collaborators: Prof. Dr. Astrid Weyerbrock, Klinik für Neurochirurgie, Kantonsspital St. Gallen; PD Dr. med. Martin Stienen, Klinik für Neurochirurgie, Universitätsspital Zürich; Dr. med. Peter Prömmel, Klinik für Neurochirurgie, Kantonsspital St. Gallen; PD Dr. med. Oliver Gautschi, Neuro- und Wirbelsäulen Zentrum Zentral-schweiz, Luzern; med. pract. Markéta Sosnová, Klinik für Neurochirurgie, Kantonsspital St. Gallen
• Investigators: Principal Investigator: Nicolai Maldaner, MD, Department of Neurosurgery

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. doi: 10.3171/2020.11.SPINE201621. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): May 1, 2020
• Study Completion (ACTUAL): May 1, 2020

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (ACTUAL): June 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases; Spinal Stenosis
• Other Study ID Numbers: 6MWT DDD - 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No