Evaluations3CRTNCT03286660
3 Minutes Chair Rise Test (3CRT) in Patients With COPD
A study testing Chair Rise Tests and short questionnaire in people with Evaluations and Rehabilitation, run by University Hospital, Lille at 2 sites in France.
Trial summary
Improvement in the functional functioning and dyspnea of COPD patients after a rehabilitation program (RHB) is assessed by exercise tests and questionnaires difficult to replicate outside specialized centers. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Evaluations, Rehabilitation, COPD
- What is being tested?
- Chair Rise Tests and short questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Dec 2014to 24 Jul 2017
- Phase
- Interventional
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with COPD Gold II to IV
- Patient admitted for a rehabilitation program in real life
- Person affiliated to the Social Security or beneficiary of such a scheme
- Informed and written consent by patient or legal representative
Who cannot join
- Patient limited by reduced locomotor activity or joint pain that compromises their participation in a rehabilitation program
- Patients with a performance less than 250 meters during 6MWT
- Non-stable cardiac disease
- Any other lung disease than COPD
- Person subject to a legal protection measure
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Universitaire
Grenoble
Hôpital Calmette, CHRU
Lille
About this study
Official title: Chair Rise Tests for a Simplified Evaluation of Functional Response After a Rehabilitation Program in Patients COPD.
Improvement in the functional functioning and dyspnea of COPD patients after a rehabilitation program (RHB) is assessed by exercise tests and questionnaires difficult to replicate outside specialized centers.
In order to monitor the eventual decline of patients in the course of their RHB management, Chair Rise Tests (3CRT-1CRT-5STS) and short questionnaires were developed (CAT-DIRECT). The goal of this prospective, multicenter, real-life study is to compare the change in several functional function tests and questionnaires of quality of life and dyspnea related to daily activities. In addition, MCIDs of the 3CRT and the DIRECT questionnaire (Disability Related to COPS Tool) were specified.
- Conditions
- Evaluations, Rehabilitation, COPD
- Being tested
- Chair Rise Tests and short questionnaire
- Keywords
- Exercise tests, COPD, Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chair Rise Tests and short questionnaireDiagnostic test
Exercises consist on a Chair Rise Tests and short questionnaire It is a functional test evaluating the number of chair rise over a given time and / or frequency.
This test is combined with a questionnaire to collect quantitative and qualitative information:
- dyspnea and muscular fatigue at rest before the start of the test and at the end of the exercise
- Saturation at rest, and at the end of the exercise
- the number of total a chair rise
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Other | All convenient COPD patients admitted in real life for a rehabilitation program were included.
Exercises consist on a Chair Rise Tests and short questionnaire were added to the usual tools for the evaluation. Receives: Diagnostic Test: Chair Rise Tests and short questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of number of rise during 3 minutes Chair Rise Test (3CRT)
The change of total number of rise during a 3 minutes Chair Rise Test (3CRT) from baseline
Measured: At Baseline, at 2 and 8 weeks.
Secondary outcomes (6)
Change of number of rise during 1 minute Chair Rise Test (1CRT)
The change of total number of rise during a 1 minutes Chair Rise Test (3CRT) from baseline
Measured: At Baseline, at 2 and 8 weeks.
Change of Time to perform 5 sit to stand
The change of Time to perform 5 sit to stand from baseline
Measured: At Baseline, at 2 and 8 weeks.
The change of Total score for the DIsability RElated to COPD Tool (DIRECT)
Total Score
Measured: At Baseline and at 8 weeks.
Difference in physiological response (SpO2 and HR) during the 3 Chair Rise Tests (3CRT-1CRT-5STS)
End SpO2 - End Heart Rate
Measured: At Baseline, at 2 and 8 weeks.
Change in endurance time at constant power on cyclo ergometer,
The change of endurance time from baseline
Measured: At Baseline, at 2 and 8 weeks.
Change of Voluntary Quadriceps force output
Change of Voluntary quadriceps force measurements (Mean of 3 maximal measurements) from baseline
Measured: At Baseline, at 2 and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start8 Dec 2014
- Primary completion24 Jul 2017
- Study completion24 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EvaluationsStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, HYLAB, Physiopathologie de l'exercice
- Responsible party
- Sponsor
- Investigators
- Bernard AGUILANIU, MD,PhD, Principal investigator, University Grenoble Alps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286660
- Sponsor's protocol ID
- 2013_58
- Other IDs
- 2014-A00856-41
- Acronym
- 3CRT
- Status last verified
- Sep 2017
- First submitted
- 9 Sep 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Levesque J, Antoniadis A, Li PZ, Herengt F, Brosson C, Grosbois JM, Bernady A, Bender A, Favre M, Guerder A, Surpas P, Similowski T, Aguilaniu B. Minimal clinically important difference of 3-minute chair rise test and the DIRECT questionnaire after pulmonary rehabilitation in COPD patients. Int J Chron Obstruct Pulmon Dis. 2019 Jan 22;14:261-269. doi: 10.2147/COPD.S187567. eCollection 2019.
PubMed 30774324
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chair Rise Tests for a Simplified Evaluation of Functional Response After a Rehabilitation Program in Patients COPD.
- ClinicalTrials.gov ID
- NCT03286660
- Acronym / sponsor ID
- 3CRT / 2013_58
- Conditions
- Evaluations, Rehabilitation, COPD
- Keywords
- Exercise tests, COPD, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim, HYLAB, Physiopathologie de l'exercice
- Study start
- 8 Dec 2014 (actual)
- Primary completion
- 24 Jul 2017 (actual)
- Study completion
- 24 Jul 2017 (actual)
- First posted
- 18 Sep 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.
Improvement in the functional functioning and dyspnea of COPD patients after a rehabilitation program (RHB) is assessed by exercise tests and questionnaires difficult to replicate outside specialized centers.
In order to monitor the eventual decline of patients in the course of their RHB management, Chair Rise Tests (3CRT-1CRT-5STS) and short questionnaires were developed (CAT-DIRECT). The goal of this prospective, multicenter, real-life study is to compare the change in several functional function tests and questionnaires of quality of life and dyspnea related to daily activities. In addition, MCIDs of the 3CRT and the DIRECT questionnaire (Disability Related to COPS Tool) were specified.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | Other | Diagnostic Test: Chair Rise Tests and short questionnaireAll convenient COPD patients admitted in real life for a rehabilitation program were included. Exercises consist on a Chair Rise Tests and short questionnaire were added to the usual tools for the evaluation. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with COPD Gold II to IV
- Patient admitted for a rehabilitation program in real life
- Person affiliated to the Social Security or beneficiary of such a scheme
- Informed and written consent by patient or legal representative
Key exclusion criteria (5 listed)
- Patient limited by reduced locomotor activity or joint pain that compromises their participation in a rehabilitation program
- Patients with a performance less than 250 meters during 6MWT
- Non-stable cardiac disease
- Any other lung disease than COPD
- Person subject to a legal protection measure
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 |
|---|---|---|
| Chair Rise Tests and short questionnaireExercises consist on a Chair Rise Tests and short questionnaire It is a functional test evaluating the number of chair rise over a given time and / or frequency. This test is combined with a questionnaire to collect quantitative and qualitative information: * dyspnea and muscular fatigue at rest before the start of the test and at the end of the exercise * Saturation at rest, and at the end of the exercise * the number of total a chair rise | Diagnostic test | COPD patients |
Primary outcome
Change of number of rise during 3 minutes Chair Rise Test (3CRT)
Time frame: At Baseline, at 2 and 8 weeks.
The change of total number of rise during a 3 minutes Chair Rise Test (3CRT) from baseline
6 secondary outcomes
Change of number of rise during 1 minute Chair Rise Test (1CRT)
Time frame: At Baseline, at 2 and 8 weeks.
Change of Time to perform 5 sit to stand
Time frame: At Baseline, at 2 and 8 weeks.
The change of Total score for the DIsability RElated to COPD Tool (DIRECT)
Time frame: At Baseline and at 8 weeks.
Difference in physiological response (SpO2 and HR) during the 3 Chair Rise Tests (3CRT-1CRT-5STS)
Time frame: At Baseline, at 2 and 8 weeks.
Change in endurance time at constant power on cyclo ergometer,
Time frame: At Baseline, at 2 and 8 weeks.
Change of Voluntary Quadriceps force output
Time frame: At Baseline, at 2 and 8 weeks.
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 18 Sep 2017.
- Derived from this study: PubMed 30774324Levesque J, Antoniadis A, Li PZ, Herengt F, Brosson C, Grosbois JM, Bernady A, Bender A, Favre M, Guerder A, Surpas P, Similowski T, Aguilaniu B. Minimal clinically important difference of 3-minute chair rise test and the DIRECT questionnaire after pulmonary rehabilitation in COPD patients. Int J Chron Obstruct Pulmon Dis. 2019 Jan 22;14:261-269. doi: 10.2147/COPD.S187567. eCollection 2019.
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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.
Bernard AGUILANIU, MD,PhD principal investigator
University Grenoble Alps
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chair Rise Tests and short questionnaire in people with Evaluations and Rehabilitation, run by University Hospital, Lille at 2 sites in France.
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 4 inclusion and 5 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 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Change of number of rise during 3 minutes Chair Rise Test (3CRT) (time frame: At Baseline, at 2 and 8 weeks.). 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 NCT03286660, which also lists 1 linked publication.
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 18 Sep 2017.