Degenerative Disc Disease5RSTS-2NCT03321357
Retest-reliability and At-home-assessment Feasibility of the 5R-STS
An observational study of Degenerative Disc Disease and Spondylolisthesis, run by Bergman Clinics at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Disc Disease, Spondylolisthesis, Spondylosis
- What is being tested?
- five-repetition sit-to-stand test
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Dec 2017to 21 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with symptomatic degenerative diseases of the lumbar spine that come in for surgical treatment
Who may be able to join
- Degenerative diseases of the lumbar spine (Herniated disc, lumbar stenosis, spondylolisthesis, degenerative disc disease)
- Symptoms of lower back pain, neurogenic claudication, or radiculopathy
Who cannot join
- Hip or Knee prosthetics
- Walking aides
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Patients will perform three 5R-STS measurements:
- During outpatient clinics, time measured by the physician
- At home, time measured by partner/family
- At home, and assessed by producing a video recording of the 5R-STS performance that is subsequently sent and analyzed (time measured digitally)
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spondylosis, Herniated Nucleus Pulposus, Spinal Stenosis Lumbar, Spinal Diseases
- Being tested
- five-repetition sit-to-stand test
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis, Spondylosis, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
five-repetition sit-to-stand testDiagnostic test
Also called 5R-STS
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
5R-STS
Objective functional test measuring the amount of functional impairment.
Measured: 0 months
Secondary outcomes (5)
EQ-5D-3L
Validated questionnaire measuring quality of life
Measured: 0 months
Oswestry Disability Index
Validated questionnaire measuring functional disability
Measured: 0 months
VAS leg pain severity
Validated questionnaire measuring pain
Measured: 0 months
VAS back pain severity
Validated questionnaire measuring pain
Measured: 0 months
Roland Morris Disability Questionnaire
Validated questionnaire measuring functional disability
Measured: 0 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start8 Dec 2017
- Primary completion1 Jun 2018
- Study completion21 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bergman Clinics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Schröder, Bergman Clinics
- Investigators
- Victor E. Staartjes, MSIII, Principal investigator, Department of Neurosurgery, Bergman Clinics, Naarden, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321357
- Sponsor's protocol ID
- 5R-STS-2
- Acronym
- 5RSTS-2
- Status last verified
- Jul 2018
- First submitted
- 23 Oct 2017
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23783372Staartjes VE, Klukowska AM, Stumpo V, Vandertop WP, Schroder ML. Identifying clusters of objective functional impairment in patients with degenerative lumbar spinal disease using unsupervised learning. Eur Spine J. 2024 Apr;33(4):1320-1331. doi: 10.1007/s00586-023-08070-z. Epub 2023 Dec 21.
PubMed 38127138Klukowska 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.
PubMed 36477416Staartjes 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.
PubMed 31451936Staartjes 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.
PubMed 30680635
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-retest-reliability and At-home-assessment Feasibility of the Five-repetition Sit-to-stand Test (5R-STS)
- ClinicalTrials.gov ID
- NCT03321357
- Acronym / sponsor ID
- 5RSTS-2 / 5R-STS-2
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spondylosis, Herniated Nucleus Pulposus, Spinal Stenosis Lumbar, Spinal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bergman ClinicsUniversity, hospital or other
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will perform three 5R-STS measurements:
- During outpatient clinics, time measured by the physician
- At home, time measured by partner/family
- At home, and assessed by producing a video recording of the 5R-STS performance that is subsequently sent and analyzed (time measured digitally)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with symptomatic degenerative diseases of the lumbar spine that come in for surgical treatment
Key inclusion criteria (2 listed)
- Degenerative diseases of the lumbar spine (Herniated disc, lumbar stenosis, spondylolisthesis, degenerative disc disease)
- Symptoms of lower back pain, neurogenic claudication, or radiculopathy
Key exclusion criteria (2 listed)
- Hip or Knee prosthetics
- Walking aides
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| five-repetition sit-to-stand testAlso: 5R-STSAn 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. | Diagnostic test | – |
Primary outcome
5R-STS
Time frame: 0 months
Objective functional test measuring the amount of functional impairment.
5 secondary outcomes
EQ-5D-3L
Time frame: 0 months
Oswestry Disability Index
Time frame: 0 months
VAS leg pain severity
Time frame: 0 months
VAS back pain severity
Time frame: 0 months
Roland Morris Disability Questionnaire
Time frame: 0 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Results publication: PubMed 23783372Jones 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.
- Derived from this study: PubMed 38127138Staartjes VE, Klukowska AM, Stumpo V, Vandertop WP, Schroder ML. Identifying clusters of objective functional impairment in patients with degenerative lumbar spinal disease using unsupervised learning. Eur Spine J. 2024 Apr;33(4):1320-1331. doi: 10.1007/s00586-023-08070-z. Epub 2023 Dec 21.
- Derived from this study: PubMed 36477416Klukowska 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.
- Derived from this study: PubMed 31451936Staartjes 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.
- Derived from this study: PubMed 30680635Staartjes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor E. Staartjes, MSIII principal investigator
Department of Neurosurgery, Bergman Clinics, Naarden, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Spondylolisthesis, run by Bergman Clinics at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5R-STS (time frame: 0 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03321357, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.