COPDNCT02873780
Comparison of 3-Minute Step Test (3MStepT) and 6-Minute Walk Test (6MWT) in COPD Patients
An observational study of COPD and Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier des Pays de Morlaix at 1 site in France.
Trial summary
The aim of this study is to compare oxygen desaturation during two tests: the 6 minute walk test and the 3 minute step test, for COPD patients. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Sep 2016
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients hospitalized for pulmonary rehabilitation program
Who may be able to join
- stable COPD patients hospitalized for pulmonary rehabilitation program
Who cannot join
- acute exacerbation of COPD
- incapacity to realize the tests
- absence of written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of 3-Minute Step Test (3MStepT) and 6-Minute Walk Test (6MWT) in Chronic Obstructive Pulmonary Disease Patients
The aim of this study is to compare oxygen desaturation during two tests: the 6 minute walk test and the 3 minute step test, for COPD patients.
Read the detailed description
The 6 minute walk test (6MWT) is the best field test to determine oxygen desaturation during effort, in COPD patients. However, the test need a 30m corridor.
The 3 minute step test (3MST) is a other field test used in COPD patients. But no study shows that 3MST can be used to determine oxygen desaturation.
The aim of this study is to compare oxygen desaturation during these to tests : the 6MWT and the 3MST.
50 patients will be included in this study.
Patients realize two 6MWT and two 3MST, with rest between each test.
Oxygen saturation, heart rate are registered during the tests, dyspnea, leg peniblility are notified before and after each test, distance or number of steps are noted.
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Keywords
- Pulmonary rehabilitation, COPD, Evaluation, oxygen desaturation, exercise capacity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen saturation
oxygen saturation is compared between 6MWT and 3MST at the end of the 2 tests
Measured: 3 minutes
Secondary outcomes (3)
heart rate
heart rate is compared between 6MWT and 3MST at the end of the 2 tests
Measured: 3 minutes
dyspnea (Borg Scale)
dyspnea (Borg Scale) is compared between 6MWT and 3MST at the end of the 2 tests
Measured: 3 minutes
leg penibility (Borg Scale)
leg penibility (Borg Scale) is compared between 6MWT and 3MST at the end of the 2 tests
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier des Pays de Morlaix
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Beaumont, Centre Hospitalier des Pays de Morlaix
- Investigators
- Marc Beaumont, PT, Principal investigator, France, Britain, CH Des Pays de MorlaixGregory Reychler, PT, PhD, Principal investigator, Belgium, Cliniques universitaires de Saint Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873780
- Sponsor's protocol ID
- BE403201317621
- Status last verified
- Jan 2017
- First submitted
- 31 Jul 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Roberts MM, Cho JG, Sandoz JS, Wheatley JR. Oxygen desaturation and adverse events during 6-min walk testing in patients with COPD. Respirology. 2015 Apr;20(3):419-25. doi: 10.1111/resp.12471. Epub 2015 Jan 20.
PubMed 25601398Polkey MI, Spruit MA, Edwards LD, Watkins ML, Pinto-Plata V, Vestbo J, Calverley PM, Tal-Singer R, Agusti A, Bakke PS, Coxson HO, Lomas DA, MacNee W, Rennard S, Silverman EK, Miller BE, Crim C, Yates J, Wouters EF, Celli B; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Study Investigators. Six-minute-walk test in chronic obstructive pulmonary disease: minimal clinically important difference for death or hospitalization. Am J Respir Crit Care Med. 2013 Feb 15;187(4):382-6. doi: 10.1164/rccm.201209-1596OC. Epub 2012 Dec 21.
PubMed 23262518Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
PubMed 25359355
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 3-Minute Step Test (3MStepT) and 6-Minute Walk Test (6MWT) in Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT02873780
- Acronym / sponsor ID
- BE403201317621
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Keywords
- Pulmonary rehabilitation, COPD, Evaluation, oxygen desaturation, exercise capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier des Pays de MorlaixUniversity, hospital or other
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study start
- Jul 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Aug 2016 (estimated)
- 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 aim of this study is to compare oxygen desaturation during two tests: the 6 minute walk test and the 3 minute step test, for COPD patients.
Detailed description
The 6 minute walk test (6MWT) is the best field test to determine oxygen desaturation during effort, in COPD patients. However, the test need a 30m corridor.
The 3 minute step test (3MST) is a other field test used in COPD patients. But no study shows that 3MST can be used to determine oxygen desaturation.
The aim of this study is to compare oxygen desaturation during these to tests : the 6MWT and the 3MST.
50 patients will be included in this study.
Patients realize two 6MWT and two 3MST, with rest between each test.
Oxygen saturation, heart rate are registered during the tests, dyspnea, leg peniblility are notified before and after each test, distance or number of steps are noted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients hospitalized for pulmonary rehabilitation program
Key inclusion criteria (1 listed)
- stable COPD patients hospitalized for pulmonary rehabilitation program
Key exclusion criteria (3 listed)
- acute exacerbation of COPD
- incapacity to realize the tests
- absence of written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
oxygen saturation
Time frame: 3 minutes
oxygen saturation is compared between 6MWT and 3MST at the end of the 2 tests
3 secondary outcomes
heart rate
Time frame: 3 minutes
dyspnea (Borg Scale)
Time frame: 3 minutes
leg penibility (Borg Scale)
Time frame: 3 minutes
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 31 Jan 2017.
- Results publication: PubMed 25601398Roberts MM, Cho JG, Sandoz JS, Wheatley JR. Oxygen desaturation and adverse events during 6-min walk testing in patients with COPD. Respirology. 2015 Apr;20(3):419-25. doi: 10.1111/resp.12471. Epub 2015 Jan 20.
- Results publication: PubMed 23262518Polkey MI, Spruit MA, Edwards LD, Watkins ML, Pinto-Plata V, Vestbo J, Calverley PM, Tal-Singer R, Agusti A, Bakke PS, Coxson HO, Lomas DA, MacNee W, Rennard S, Silverman EK, Miller BE, Crim C, Yates J, Wouters EF, Celli B; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Study Investigators. Six-minute-walk test in chronic obstructive pulmonary disease: minimal clinically important difference for death or hospitalization. Am J Respir Crit Care Med. 2013 Feb 15;187(4):382-6. doi: 10.1164/rccm.201209-1596OC. Epub 2012 Dec 21.
- Results publication: PubMed 25359355Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
- Individual participant dataSharing planned: Yes
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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.
Marc Beaumont, PT principal investigator
France, Britain, CH Des Pays de Morlaix
Gregory Reychler, PT, PhD principal investigator
Belgium, Cliniques universitaires de Saint Luc
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 COPD and Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier des Pays de Morlaix at 1 site 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 1 inclusion and 3 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 31 Jan 2017. 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 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?
oxygen saturation (time frame: 3 minutes). 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 NCT02873780, which also lists 3 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 31 Jan 2017.