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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03977961
Other study ID # 6MWT DDD - 1.0
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date May 1, 2020

Study information

Verified date July 2022
Source Cantonal Hospital of St. Gallen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Switzerland Kantonsspital St. Gallen / Department of Neurosurgery St. Gallen Saint Gallen

Sponsors (6)

Lead Sponsor Collaborator
Cantonal Hospital of St. Gallen Dr. med. Peter Prömmel, Klinik für Neurochirurgie, Kantonsspital St. Gallen, med. pract. Markéta Sosnová, Klinik für Neurochirurgie, Kantonsspital St. Gallen, PD Dr. med. Martin Stienen, Klinik für Neurochirurgie, Universitätsspital Zürich, PD Dr. med. Oliver Gautschi, Neuro- und Wirbelsäulen Zentrum Zentral-schweiz, Luzern, Prof. Dr. Astrid Weyerbrock, Klinik für Neurochirurgie, Kantonsspital St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary TTFS/ZCQ baseline Correlation of TTFS/DTFS in the 6MWT with the ZCQ score at baseline 4-12 weeks
Secondary TTFS/ZCQ follow-up Correlation of TTFS in the 6MWT with the ZCQ score at follow-up 4-12 weeks
Secondary TTFS/COMI baseline Correlation of TTFS/DTFS in the 6MWT with the COMI score at baseline 4-12 weeks
Secondary TTFS/COMI follow-up Correlation of TTFS/DTFS in the 6MWT with the COMI score at follow-up 4-12 weeks
Secondary TTFS/TUG baseline Correlation of TTFS/DTFS in the 6MWT with the Timed up go Test (TUG) at baseline 4-12 weeks
Secondary TTFS/TUG follow-up Correlation of TTFS/DTFS in the 6MWT with the TUG at follow-up 4-12 weeks
Secondary 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
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