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

Completed

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

• Registration Number: NCT03977961
• Lead Sponsor: Cantonal Hospital of St. Gallen

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.

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-06
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kantonsspital St. Gallen / Department of Neurosurgery; 🇨🇭 St. Gallen, Saint Gallen, Switzerland