Retest-reliability and At-home-assessment Feasibility of the 5R-STS (5RSTS-2)

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Diseases; Degenerative Disc Disease; Spinal Stenosis Lumbar; Spondylosis; Spondylolisthesis; Herniated Nucleus Pulposus; Spinal Instability
• Intervention / Treatment: Diagnostic test: five-repetition sit-to-stand test

Detailed 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)

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Netherlands
  • Naarden, Netherlands, 1411 GE
    • Bergman Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5R-STS	Objective functional test measuring the amount of functional impairment.	0 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D-3L	Validated questionnaire measuring quality of life	0 months
Oswestry Disability Index	Validated questionnaire measuring functional disability	0 months
VAS leg pain severity	Validated questionnaire measuring pain	0 months
VAS back pain severity	Validated questionnaire measuring pain	0 months
Roland Morris Disability Questionnaire	Validated questionnaire measuring functional disability	0 months

Collaborators and Investigators

• Sponsor: Bergman Clinics
• Investigators: Principal Investigator: Victor E. Staartjes, MSIII, Department of Neurosurgery, Bergman Clinics, Naarden, The Netherlands

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 8, 2017
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): June 21, 2018

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (ACTUAL): October 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spondylolysis; Intervertebral Disc Degeneration; Spinal Diseases; Spinal Stenosis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: 5R-STS-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No