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

Lumbar Spinal Stenosis Clinical Trial

— 6MWT-DDD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03977961
• Other study ID #: 6MWT DDD - 1.0
• Status: Completed
• 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
• 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
• 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.).

Related Conditions & MeSH terms

• Lumbar Disc Disease
• Lumbar Spinal Stenosis
• Lumbar Spine Degeneration
• Spinal Diseases
• Spinal Stenosis

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