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

NCT03321357 | Completed

• 1 other identifier: 5R-STS-2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degenerative Disc Disease; Spondylolisthesis; Spondylosis; Herniated Nucleus Pulposus; Spinal Stenosis Lumbar; Spinal Diseases; Spinal Instability

Outcome Measures

Primary Outcomes (1)

• 5R-STS

  Objective functional test measuring the amount of functional impairment.

  0 months

Secondary Outcomes (5)

• EQ-5D-3L

  0 months

• Oswestry Disability Index

  0 months

• VAS leg pain severity

  0 months

• VAS back pain severity

  0 months

• Roland Morris Disability Questionnaire

  0 months

Interventions

five-repetition sit-to-stand test DIAGNOSTIC_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.

Also known as: 5R-STS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic degenerative diseases of the lumbar spine that come in for surgical treatment

You may qualify if:

• Degenerative diseases of the lumbar spine (Herniated disc, lumbar stenosis, spondylolisthesis, degenerative disc disease)
• Symptoms of lower back pain, neurogenic claudication, or radiculopathy

You may not qualify if:

• Hip or Knee prosthetics
• Walking aides

Sponsors & Collaborators

• Bergman Clinics: lead

Study Sites (1)

Bergman Clinics

Naarden, 1411 GE, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 23783372 RESULT

• Klukowska AM, Staartjes VE, Vandertop WP, Schroder ML. Predictors of five-repetition sit-to-stand test performance in patients with lumbar degenerative disease. Acta Neurochir (Wien). 2023 Jan;165(1):107-115. doi: 10.1007/s00701-022-05441-1. Epub 2022 Dec 7.

  PMID: 36477416 DERIVED

• Staartjes VE, Klukowska AM, Schroder ML. Association of maximum back and leg pain severity with objective functional impairment as assessed by five-repetition sit-to-stand testing: analysis of two prospective studies. Neurosurg Rev. 2020 Oct;43(5):1331-1338. doi: 10.1007/s10143-019-01168-3. Epub 2019 Aug 26.

  PMID: 31451936 DERIVED

• Staartjes VE, Beusekamp F, Schroder ML. Can objective functional impairment in lumbar degenerative disease be reliably assessed at home using the five-repetition sit-to-stand test? A prospective study. Eur Spine J. 2019 Apr;28(4):665-673. doi: 10.1007/s00586-019-05897-3. Epub 2019 Jan 24.

  PMID: 30680635 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis; Spondylosis; Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Spondylolysis

Study Officials

• Victor E. Staartjes, MSIII

  Department of Neurosurgery, Bergman Clinics, Naarden, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: October 25, 2017
• Study Start: December 8, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 21, 2018
• Last Updated: July 13, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)