COPD Chronic Obstructive Pulmonary Disease6MSTNCT06447831
Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases
An observational study of COPD Chronic Obstructive Pulmonary Disease and Interstitial Lung Disease, run by Laval University at 3 sites in 2 countries.
Trial summary
The goal of this validation study is to provide further evidence of the metrological properties of the 6-minute stepper test in individuals with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease
- How many people
- 89 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 2 Feb 2024to 1 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with chronic obstructive pulmonary disease or interstitial lung disease followed in outpatient hospital settings
Who may be able to join
- Adult ≥ 40 years old
- Diagnosis of chronic obstructive pulmonary disease (GOLDa 2 to 4) or of interstitial lung disease (\> 6 months)
- Clinically stable for ≥ 4 weeks
Who cannot join
- Interstitial lung disease associated with connective tissue disease and sarcoidosis (often accompanied with multisystemic effects)
- Unstable or severe cardiac condition
- Invalidating rheumatologic or neurologic condition
- Weight exceeding maximal limits of exercise equipment (e.g., 130 kg for the stepper)
- Any other physical condition limiting or contraindicating exercise testing
- Simultaneous participation in another study requiring changes in medication
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- Recent pulmonary rehabilitation (≤1 year, potential learning bias for the 6-minute walk test and the 6-minute stepper test)
- For arm 1 only: Use of oxygen therapy (unable to perform gas analysis with oxygen therapy)
- For arm 2 only: Participation in arm 1
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lille, Hauts-de-France, 59000
FormAction Santé
Pérenchies, Hauts-de-France, 59840
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
Québec, Quebec, G1V 4G5
About this study
The goal of this validation study is to provide further evidence of the metrological properties of the 6-minute stepper test in individuals with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).
The main questions it aims to answer are:
Read more
- Is the 6-minute stepper test valid when compared to the 6-minute walk test and a maximal cardiopulmonary cycling test?
- Does the 6-minute stepper test give the same results when conducted through direct (i.e., therapist in person) and remote (i.e., videoconferencing) monitoring?
- Is the 6-minute stepper test safe when conducted at the home of the individual with direct (i.e., therapist in person) or remote (i.e., videoconferencing) monitoring?
Participants will:
- Conduct the 6-minute stepper test (several trials on separate days)
- Conduct the 6-minute walk test (1 trial on 1 day)
- Conduct a maximal cardiopulmonary test on a cycle ergometer (1 trial on 1 day)
- Participate in a semi-structured interview to provide their feedback with regards to the 6-minute stepper test
- Keywords
- Chronic Obstructive Pulmonary Disease, Exercise Capacity Test, Interstitial Lung Diseases, Physiotherapy, Rehabilitation, Telerehabilitation, Validation Study, Stepper Test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
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 |
|---|---|---|
| Lab testing (study 1) | Two 3-hour laboratory visits (separated by 6 to 18 days) will be conducted. During the first laboratory visit, anthropometric measurements, pulmonary function tests and CPET on a cycle ergometer will be performed. During the second laboratory visit, spirometry will be repeated to ensure stability of the participants health state (particularly relevant for individuals with COPD). Thereafter, the 6MST and 6MWT will be performed in a randomized order, separated by a rest period of at least 30 minutes. | |
| At home testing (study 2) | Three 1-hour home visits (separated by 2 to 5 days) will be conducted. The first trial of the 6MST (familiarization trial) will be conducted at the participant's home with the therapist present. The second and third trials of the 6MST will be performed in a randomized order, with either direct (therapist present at the home) or remote (therapist present through videoconferencing software, as in a telerehabilitation setting) monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concurrent validity
Assessed using paired sample t-tests (or Wilcoxon signed-rank tests) to verify whether peak cardiorespiratory (e.g., oxygen consumption, minute ventilation, heart rate, etc.) and symptomology (i.e., dyspnea and leg fatigue) values obtained during the 6-minute stepper test are comparable to the maximal cardiopulmonary test and the 6-minute walk test
Measured: Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)
Strength of association between peak cardiorespiratory and symptomology values
Pearson's correlation coefficients (r) will be calculated between the number of steps taken during the 6-minute stepper test and peak oxygen consumption and heart rate reached during all three tests
Measured: Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)
Agreement
Assessed with Bland-Altman plots and 95% limits of agreement (mean difference ± 1.96 standard deviation of the difference) between peak cardiorespiratory and symptomology values reached during the 6-minute stepper test and those reached during the maximal cardiopulmonary test and the 6-minute walk test
Measured: Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)
Test-restest reliability
Reliability (trial 2 versus 3 = directly versus remotely monitored) will be assessed using paired sample t-tests (or Wilcoxon signed-rank tests), Bland-Altman plots (with 95% limits of agreement), and intraclass correlations
Measured: Study 2 - Trial 2 and 3 (separated by 2 to 5 days)
Secondary outcomes (2)
Adverse events
All minor and serious adverse events, for all trials, will be reported
Measured: Through study completion, an average of 2 years
Level of comfort during test and perception of safety (qualitative)
Assessed with thematic content analysis of semi-structured interviews (voice-recorded and transcribed)
Measured: Study 2 - Trial 3 (semi-structured interview of 20 to 30 minutes following the completion of the last trial of the 6MST)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start2 Feb 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
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 COPD Chronic Obstructive Pulmonary 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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Groupement des Hôpitaux de l'Institut Catholique de Lille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447831
- Sponsor's protocol ID
- 2024-4075, 22380
- Acronym
- 6MST
- Status last verified
- Aug 2025
- First submitted
- 2 Feb 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bass A, Gephine S, Martin M, Belley M, Robic M, Fabre C, Grosbois JM, Dion G, Saey D, Chambellan A, Maltais F. Assessing Functional Capacity in Directly and Remotely Monitored Home-Based Settings in Individuals With Chronic Respiratory Diseases: Protocol for a Multinational Validation Study. JMIR Res Protoc. 2024 Jun 28;13:e57404. doi: 10.2196/57404.
PubMed 38941132
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases
- ClinicalTrials.gov ID
- NCT06447831
- Acronym / sponsor ID
- 6MST / 2024-4075, 22380
- Keywords
- Chronic Obstructive Pulmonary Disease, Exercise Capacity Test, Interstitial Lung Diseases, Physiotherapy, Rehabilitation, Telerehabilitation, Validation Study, Stepper Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Groupement des Hôpitaux de l'Institut Catholique de Lille
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 7 Jun 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.
The goal of this validation study is to provide further evidence of the metrological properties of the 6-minute stepper test in individuals with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).
The main questions it aims to answer are:
- Is the 6-minute stepper test valid when compared to the 6-minute walk test and a maximal cardiopulmonary cycling test?
- Does the 6-minute stepper test give the same results when conducted through direct (i.e., therapist in person) and remote (i.e., videoconferencing) monitoring?
- Is the 6-minute stepper test safe when conducted at the home of the individual with direct (i.e., therapist in person) or remote (i.e., videoconferencing) monitoring?
Participants will:
- Conduct the 6-minute stepper test (several trials on separate days)
- Conduct the 6-minute walk test (1 trial on 1 day)
- Conduct a maximal cardiopulmonary test on a cycle ergometer (1 trial on 1 day)
- Participate in a semi-structured interview to provide their feedback with regards to the 6-minute stepper test
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lab testing (study 1) | – | –Two 3-hour laboratory visits (separated by 6 to 18 days) will be conducted. During the first laboratory visit, anthropometric measurements, pulmonary function tests and CPET on a cycle ergometer will be performed. During the second laboratory visit, spirometry will be repeated to ensure stability of the participants health state (particularly relevant for individuals with COPD). Thereafter, the 6MST and 6MWT will be performed in a randomized order, separated by a rest period of at least 30 minutes. |
| At home testing (study 2) | – | –Three 1-hour home visits (separated by 2 to 5 days) will be conducted. The first trial of the 6MST (familiarization trial) will be conducted at the participant's home with the therapist present. The second and third trials of the 6MST will be performed in a randomized order, with either direct (therapist present at the home) or remote (therapist present through videoconferencing software, as in a telerehabilitation setting) monitoring. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with chronic obstructive pulmonary disease or interstitial lung disease followed in outpatient hospital settings
Key inclusion criteria (3 listed)
- Adult ≥ 40 years old
- Diagnosis of chronic obstructive pulmonary disease (GOLDa 2 to 4) or of interstitial lung disease (\> 6 months)
- Clinically stable for ≥ 4 weeks
Key exclusion criteria (9 listed)
- Interstitial lung disease associated with connective tissue disease and sarcoidosis (often accompanied with multisystemic effects)
- Unstable or severe cardiac condition
- Invalidating rheumatologic or neurologic condition
- Weight exceeding maximal limits of exercise equipment (e.g., 130 kg for the stepper)
- Any other physical condition limiting or contraindicating exercise testing
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
Concurrent validity
Time frame: Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)
Assessed using paired sample t-tests (or Wilcoxon signed-rank tests) to verify whether peak cardiorespiratory (e.g., oxygen consumption, minute ventilation, heart rate, etc.) and symptomology (i.e., dyspnea and leg fatigue) values obtained during the 6-minute stepper test are comparable to the maximal cardiopulmonary test and the 6-minute walk test
Strength of association between peak cardiorespiratory and symptomology values
Time frame: Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)
Pearson's correlation coefficients (r) will be calculated between the number of steps taken during the 6-minute stepper test and peak oxygen consumption and heart rate reached during all three tests
Agreement
Time frame: Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)
Assessed with Bland-Altman plots and 95% limits of agreement (mean difference ± 1.96 standard deviation of the difference) between peak cardiorespiratory and symptomology values reached during the 6-minute stepper test and those reached during the maximal cardiopulmonary test and the 6-minute walk test
Test-restest reliability
Time frame: Study 2 - Trial 2 and 3 (separated by 2 to 5 days)
Reliability (trial 2 versus 3 = directly versus remotely monitored) will be assessed using paired sample t-tests (or Wilcoxon signed-rank tests), Bland-Altman plots (with 95% limits of agreement), and intraclass correlations
2 secondary outcomes
Adverse events
Time frame: Through study completion, an average of 2 years
Level of comfort during test and perception of safety (qualitative)
Time frame: Study 2 - Trial 3 (semi-structured interview of 20 to 30 minutes following the completion of the last trial of the 6MST)
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 26 Aug 2026.
- Derived from this study: PubMed 38941132Bass A, Gephine S, Martin M, Belley M, Robic M, Fabre C, Grosbois JM, Dion G, Saey D, Chambellan A, Maltais F. Assessing Functional Capacity in Directly and Remotely Monitored Home-Based Settings in Individuals With Chronic Respiratory Diseases: Protocol for a Multinational Validation Study. JMIR Res Protoc. 2024 Jun 28;13:e57404. doi: 10.2196/57404.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Chronic Obstructive Pulmonary Disease and Interstitial Lung Disease, run by Laval University at 3 sites in 2 countries.
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 3 inclusion and 9 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Canada. 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?
Concurrent validity (time frame: Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)). The study lists 4 primary outcomes in all. 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 NCT06447831, 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 26 Aug 2026.