COPDSixSTeM-COPDNCT06703359
Predictive Properties of the 6-Minute Stepper Test for Mortality in COPD
An observational study of COPD, run by ADIR Association at 1 site in France.
Trial summary
Retrospective study aimed to answer the following research questions : What are the predictive properties of the 6-minute stepper in COPD for 2-year mortality in individuals with COPD ? What are the predictive properties of the 6-minute stepper in COPD for 5-year mortality in invididuals with COPD ? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2024to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with COPD referred for pulmonary rehabilitation.
Who may be able to join
- Age > 18 years;
- Covered by a social security scheme;
- COPD (all stages);
- Referred for pulmonary rehabilitation;
- Completed a 6-Minute Stepper Test at the start of their program.
- Non-inclusion Criteria:
- Patients under guardianship or legal supervision;
- Pregnant or breastfeeding women.
Who cannot join
- Not applicable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
ADIR Association
Rouen, 76000
Tristan Bonnevie, PhD, +33235592970, t.bonnevie@adir-hautenormandie.com
Tristan Bonnevie, PhD
About this study
Official title: Evaluation of the Predictive Properties of the 6-Minute Stepper Test for Long-term Mortality in Patients with COPD
Retrospective study aimed to answer the following research questions :
- What are the predictive properties of the 6-minute stepper in COPD for 2-year mortality in individuals with COPD ?
- What are the predictive properties of the 6-minute stepper in COPD for 5-year mortality in invididuals with COPD ?
Read the detailed description
Method: retrospective study with external validation.
The medical records of all patients referred for pulmonary rehabilitation at ADIR Association, France, between 2015 and 2023 will be screened for eligibility. Demographic data and performance during the 6-Minute Stepper Test will be collected directly from the patients' medical records.
Collected data include: age, weight, height, body-mass index, sex, long-term oxygen therapy, long-term non-invasive ventilation, oxygen uptake (from cardiopulmonary exercise testing), peak power output (from cardiopulmonary exercise testing), pulmonary function testing, disease stage according to the Global Initiative for Chronic Obstructive Lung Disease classification, modified Medical Research Council dyspnea score, smoking status, quality of life, number of disease exacerbations prior to the pulmonary rehabilitation program, number of pulmonary rehabilitation programs performed during the follow-up period, and performance during the 6-Minute Stepper Test.
Vital status (alive or deceased) will be collected from the database of the French National Institute of Statistics and Economic Studies (INSEE): https://arbre.app/insee. This variable will be collected during the first quarter of 2025.
A receiver operator curve analysis will be performed to determine the statistical threshold value (number of steps) with the best sensitivity and specificity for predicting all-cause mortality at 2 and 5 years.
Patients will then be divided into two groups based on the established threshold, and a Cox regression model will be used to determine the hazard ratio for mortality at 2 and 5 years.
Invidiual participant data from a prospective study will be used to assess the external validity of established thresholds.(https://pubmed.ncbi.nlm.nih.gov/27216848/).
Statistical analysis :
Continuous data will be expressed as mean (standard deviation), median (interquartile range), and categorical data as number (percentage). The distribution of data will be assessed using the Shapiro-Wilk test.
To determine the statistical threshold value of the 6-Minute Stepper Test with the best sensitivity and specificity for 2-year and 5-year mortality, receivor operator curves (95% confience interval) will be generated.
Patients will then be divided into two groups (based on the threshold value). The characteristics of the two groups will be compared using Fisher's exact test (categorical data), the independent Student's t-test (parametric data), or the Mann-Whitney U test (non-parametric data).
A Cox proportional hazards regression model will be used to calculate the "crude" and "adjusted" hazard ratio (95% confidence interval) for 2-year and 5-year mortality. The adjusted model will include the following variables: sex, age, FEV1 (L), modified Medical Research Council dyspnea score, BMI. Sensitivity analysis will be porformed adding smoking status, long term oxygen use and number of pulmonary rehabilitation during the follow-up.
The external validity of the model will be assessed using individual pariticipant data from a previously published study (https://pubmed.ncbi.nlm.nih.gov/27216848/).
- Conditions
- COPD
- Keywords
- COPD, Six-minute stepper test, Pulmonary rehabilitation, Exercise testing
- 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.
| Study group | Role | What they receive |
|---|---|---|
| COPD referred for pulmonary rehabilitation. | Included participant were referred for pulmonary. During their baseline assessment, they performed the 6-Minute Stepper Test and were then followed for 5 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year mortality
Vital status (alive or deceased) will be collected from the database of the French National Institute of Statistics and Economic Studies (INSEE): https://arbre.app/insee.
Measured: From the 6-Minute Stepper Test to two years thereafter
Five-year mortality
Vital status (alive or deceased) will be collected from the database of the French National Institute of Statistics and Economic Studies (INSEE): https://arbre.app/insee.
Measured: From the 6-Minute Stepper Test to five years thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ADIR Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tristan Bonnevie, PhD, Principal investigator, ADIR Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703359
- Sponsor's protocol ID
- SixSTeM-COPD
- Acronym
- SixSTeM-COPD
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon reasonnable request for research purpose after publication. Request should be send to t.bonnevie@adir-hautenormandie.com
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Predictive Properties of the 6-Minute Stepper Test for Long-term Mortality in Patients with COPD
- ClinicalTrials.gov ID
- NCT06703359
- Acronym / sponsor ID
- SixSTeM-COPD / SixSTeM-COPD
- Conditions
- COPD
- Keywords
- COPD, Six-minute stepper test, Pulmonary rehabilitation, Exercise testing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- ADIR AssociationUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 25 Nov 2024 (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.
Retrospective study aimed to answer the following research questions :
- What are the predictive properties of the 6-minute stepper in COPD for 2-year mortality in individuals with COPD ?
- What are the predictive properties of the 6-minute stepper in COPD for 5-year mortality in invididuals with COPD ?
Detailed description
Method: retrospective study with external validation.
The medical records of all patients referred for pulmonary rehabilitation at ADIR Association, France, between 2015 and 2023 will be screened for eligibility. Demographic data and performance during the 6-Minute Stepper Test will be collected directly from the patients' medical records.
Collected data include: age, weight, height, body-mass index, sex, long-term oxygen therapy, long-term non-invasive ventilation, oxygen uptake (from cardiopulmonary exercise testing), peak power output (from cardiopulmonary exercise testing), pulmonary function testing, disease stage according to the Global Initiative for Chronic Obstructive Lung Disease classification, modified Medical Research Council dyspnea score, smoking status, quality of life, number of disease exacerbations prior to the pulmonary rehabilitation program, number of pulmonary rehabilitation programs performed during the follow-up period, and performance during the 6-Minute Stepper Test.
Vital status (alive or deceased) will be collected from the database of the French National Institute of Statistics and Economic Studies (INSEE): https://arbre.app/insee. This variable will be collected during the first quarter of 2025.
A receiver operator curve analysis will be performed to determine the statistical threshold value (number of steps) with the best sensitivity and specificity for predicting all-cause mortality at 2 and 5 years.
Patients will then be divided into two groups based on the established threshold, and a Cox regression model will be used to determine the hazard ratio for mortality at 2 and 5 years.
Invidiual participant data from a prospective study will be used to assess the external validity of established thresholds.(https://pubmed.ncbi.nlm.nih.gov/27216848/).
Statistical analysis :
Continuous data will be expressed as mean (standard deviation), median (interquartile range), and categorical data as number (percentage). The distribution of data will be assessed using the Shapiro-Wilk test.
To determine the statistical threshold value of the 6-Minute Stepper Test with the best sensitivity and specificity for 2-year and 5-year mortality, receivor operator curves (95% confience interval) will be generated.
Patients will then be divided into two groups (based on the threshold value). The characteristics of the two groups will be compared using Fisher's exact test (categorical data), the independent Student's t-test (parametric data), or the Mann-Whitney U test (non-parametric data).
A Cox proportional hazards regression model will be used to calculate the "crude" and "adjusted" hazard ratio (95% confidence interval) for 2-year and 5-year mortality. The adjusted model will include the following variables: sex, age, FEV1 (L), modified Medical Research Council dyspnea score, BMI. Sensitivity analysis will be porformed adding smoking status, long term oxygen use and number of pulmonary rehabilitation during the follow-up.
The external validity of the model will be assessed using individual pariticipant data from a previously published study (https://pubmed.ncbi.nlm.nih.gov/27216848/).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD referred for pulmonary rehabilitation. | – | –Included participant were referred for pulmonary. During their baseline assessment, they performed the 6-Minute Stepper Test and were then followed for 5 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with COPD referred for pulmonary rehabilitation.
Key inclusion criteria (8 listed)
- Age > 18 years;
- Covered by a social security scheme;
- COPD (all stages);
- Referred for pulmonary rehabilitation;
- Completed a 6-Minute Stepper Test at the start of their program.
Key exclusion criteria (1 listed)
- Not applicable.
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
Two-year mortality
Time frame: From the 6-Minute Stepper Test to two years thereafter
Vital status (alive or deceased) will be collected from the database of the French National Institute of Statistics and Economic Studies (INSEE): https://arbre.app/insee.
Five-year mortality
Time frame: From the 6-Minute Stepper Test to five years thereafter
Vital status (alive or deceased) will be collected from the database of the French National Institute of Statistics and Economic Studies (INSEE): https://arbre.app/insee.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: Yes. Data will be made available upon reasonnable request for research purpose after publication. Request should be send to t.bonnevie@adir-hautenormandie.com
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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.
Tristan Bonnevie, PhD principal investigator
ADIR Association
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, run by ADIR Association 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 8 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 2 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tristan Bonnevie, PhD (+33232592970, t.bonnevie@adir-hautenormandie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-year mortality (time frame: From the 6-Minute Stepper Test to two years thereafter). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2024.