NCT06447831Completed
Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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. Is the 6-minute stepper test valid when compared to the 6-minute walk test and a maximal cardiopulmonary cycling test? 2. 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? 3. 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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 89 (actual)
- First submitted
- 2 Feb 2024
- Start date
- 2 Feb 2024
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Laval University
- Diseases
- COPD
- NCT number
- NCT06447831
What you commit to
- Study type: Observational
- Participants enrolled: 89
- From 2 Feb 2024 to the primary completion date, 1 Jun 2025
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Simultaneous participation in another study requiring changes in medication
- For arm 1 only: Use of oxygen therapy (unable to perform gas analysis with oxygen therapy)
Other illness
- 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
- Any other physical condition limiting or contraindicating exercise testing
Other
- Weight exceeding maximal limits of exercise equipment (e.g., 130 kg for the stepper)
- Recent pulmonary rehabilitation (≤1 year, potential learning bias for the 6-minute walk test and the 6-minute stepper test)
- For arm 2 only: Participation in arm 1
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Université Laval Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Groupement Des Hopitaux De L'Institut Catholique De Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| FormAction Santé Coordinator of this site? Confirm its status | Pérenchies | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.