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
- Interstitial Lung DiseaseCOPD Chronic Obstructive Pulmonary Disease
- Registration Number
- NCT06447831
- Lead Sponsor
- Laval University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 82
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
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
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
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (3)
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
🇨🇦Québec, Canada
Groupement des Hôpitaux de l'Institut Catholique de Lille
🇫🇷Lille, Hauts-de-France, France
FormAction Santé
🇫🇷Pérenchies, Hauts-de-France, France