COPD Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, Exercise Capacity Test, Interstitial Lung Diseases, Physiotherapy, Rehabilitation, Telerehabilitation, Validation Study, Stepper Test
Brief 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
Interventions
None listed
Sponsors
Laval University
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Groupement des Hôpitaux de l'Institut Catholique de Lille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concurrent validity | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Through study completion, an average of 2 years | All minor and serious adverse events, for all trials, will be reported |
| Level of comfort during test and perception of safety (qualitative) | Study 2 - Trial 3 (semi-structured interview of 20 to 30 minutes following the completion of the last trial of the 6MST) | Assessed with thematic content analysis of semi-structured interviews (voice-recorded and transcribed) |
Countries
Canada, France
Outcome results
None listed