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Lumbar Disc Disease6MWT-DDDNCT03977961

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

An observational study of Lumbar Disc Disease and Lumbar Spine Degeneration, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
How many people
50 participants
Where
1 siteSwitzerland
Study dates
1 May 2019to 1 May 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.).

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Kantonsspital St. Gallen / Department of Neurosurgery

    Sankt Gallen, Canton of St. Gallen, 9000

Other trials in Switzerland

About this study

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

Read the 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.
Medical subject headings
Intervertebral disc disease, Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03977961
Study groupRoleWhat they receive
DDD PatientsAll 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Raw walking distance

    Raw walking distance (in m), as measured with the 6MWT, between the baseline- (before surgery) and follow-up assessment

    Measured: 4-12 weeks

Secondary outcomes (11)

  1. TTFS

    Difference in Time to First Symptoms (TTFS; in sec) as measured by the 6MWT, between the baseline- and follow-up assessment

    Measured: 4-12 weeks

  2. DTFS

    Difference in Distance to First Symptoms (DTFS, in m), as measured by the 6MWT, between the baseline- and follow-up assessment

    Measured: 4-12 weeks

  3. 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.

    Measured: 4-12 weeks

  4. 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

    Measured: 4-12 weeks

  5. TTFS/ZCQ baseline

    Correlation of TTFS/DTFS in the 6MWT with the ZCQ score at baseline

    Measured: 4-12 weeks

  6. TTFS/ZCQ follow-up

    Correlation of TTFS in the 6MWT with the ZCQ score at follow-up

    Measured: 4-12 weeks

  7. TTFS/COMI baseline

    Correlation of TTFS/DTFS in the 6MWT with the COMI score at baseline

    Measured: 4-12 weeks

  8. TTFS/COMI follow-up

    Correlation of TTFS/DTFS in the 6MWT with the COMI score at follow-up

    Measured: 4-12 weeks

  9. TTFS/TUG baseline

    Correlation of TTFS/DTFS in the 6MWT with the Timed up go Test (TUG) at baseline

    Measured: 4-12 weeks

  10. TTFS/TUG follow-up

    Correlation of TTFS/DTFS in the 6MWT with the TUG at follow-up

    Measured: 4-12 weeks

  11. 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.

    Measured: 6 weeks to 1 day before surgery as well as 4-12 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2019
  2. Study start1 May 2019
  3. Primary completion1 May 2020
  4. Study completion1 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03977961
Sponsor's protocol ID
6MWT DDD - 1.0
Acronym
6MWT-DDD
Status last verified
Jul 2022
First submitted
31 May 2019
Last updated
26 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37182704

  • 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.

    PubMed 35015137

  • 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.

    PubMed 34042414

  • 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.

    PubMed 34033596

  • 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.

    PubMed 33974372

Questions about this trial

What is this clinical trial studying?

An observational study of Lumbar Disc Disease and Lumbar Spine Degeneration, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Raw walking distance (time frame: 4-12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03977961, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.

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