Retest-reliability and At-home-assessment Feasibility of the 5R-STS

Degenerative Disc Disease Clinical Trial

— 5RSTS-2  

Official title:

Test-retest-reliability and At-home-assessment Feasibility of the Five-repetition Sit-to-stand Test (5R-STS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03321357
• Other study ID #: 5R-STS-2
• Status: Completed
• Start date: December 8, 2017
• Est. completion date: June 21, 2018

Study information

• Verified date: July 2018
• Source: Bergman Clinics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The five-repetition sit-to-stand test has been validated and is used primarily in pulmonary medicine and cardiology, and has recently been shown to be a useful tool for the objective assessment of functional impairment in patients with degenerative diseases of the lumbar spine.

The goal of this study is to assess the possibility of supervised and unsupervised at-home-assessment. Validation of at-home-assessment would allow the 5R-STS to be easily used as a follow-up tool in clinical trials, for example.

Description:

Patients will perform three 5R-STS measurements:

1. During outpatient clinics, time measured by the physician

2. At home, time measured by partner/family

3. At home, and assessed by producing a video recording of the 5R-STS performance that is subsequently sent and analyzed (time measured digitally)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 21, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Degenerative diseases of the lumbar spine (Herniated disc, lumbar stenosis, spondylolisthesis, degenerative disc disease)

• Symptoms of lower back pain, neurogenic claudication, or radiculopathy

Exclusion Criteria:

• Hip or Knee prosthetics

• Walking aides

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Herniated Nucleus Pulposus
• Intervertebral Disc Degeneration
• Spinal Diseases
• Spinal Instability
• Spinal Stenosis
• Spinal Stenosis Lumbar
• Spondylolisthesis
• Spondylosis

Intervention

Diagnostic Test:
• five-repetition sit-to-stand test
An armless chair with a hard seat was stabilised by placing it against a wall. Seated participants were asked to come forward on the chair seat until the feet were flat on the floor and to fold their upper limbs across the chest. Participants were then instructed to stand up all the way and sit down once without using the upper limbs. For those unable to complete the initial manoeuvre or who required assistance, the test was terminated. If successful on the initial sit to stand, participants were then asked to stand up all the way and sit down landing firmly, as fast as possible, five times without using the arms. Timing with a stopwatch was started on the command 'go' and stopped at the end of the completed fifth stand; the time taken was recorded as the participant's score. (1) Jones et al.

Locations

Country	Name	City	State
Netherlands	Bergman Clinics	Naarden

Sponsors (1)

Lead Sponsor	Collaborator
Bergman Clinics

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Jones SE, Kon SS, Canavan JL, Patel MS, Clark AL, Nolan CM, Polkey MI, Man WD. The five-repetition sit-to-stand test as a functional outcome measure in COPD. Thorax. 2013 Nov;68(11):1015-20. doi: 10.1136/thoraxjnl-2013-203576. Epub 2013 Jun 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5R-STS	Objective functional test measuring the amount of functional impairment.	0 months
Secondary	EQ-5D-3L	Validated questionnaire measuring quality of life	0 months
Secondary	Oswestry Disability Index	Validated questionnaire measuring functional disability	0 months
Secondary	VAS leg pain severity	Validated questionnaire measuring pain	0 months
Secondary	VAS back pain severity	Validated questionnaire measuring pain	0 months
Secondary	Roland Morris Disability Questionnaire	Validated questionnaire measuring functional disability	0 months