Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases
Eligible age
40+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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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: 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
Sponsor: Laval University
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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)
Source: ClinicalTrials.gov · NCT06447831 · last updated 2024-06-07