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Completed
NCT06447831
Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases
Conditions: COPD Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Enrollment: 89
Sponsor: Laval University
Location: Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval Québec Quebec
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. 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
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Source: ClinicalTrials.gov (NCT06447831). StuddyBuddy aggregates publicly available trial information.