Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COPD Chronic Obstructive Pulmonary Disease
- Sponsor
- Laval University
- Enrollment
- 82
- Locations
- 3
- Primary Endpoint
- Concurrent validity
- Status
- Recruiting
- Last Updated
- last year
Overview
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:
- Is the 6-minute stepper test valid when compared to the 6-minute walk test and a maximal cardiopulmonary cycling test?
- 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?
- 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
Investigators
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
Outcomes
Primary Outcomes
Concurrent validity
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Adverse events(Through study completion, an average of 2 years)
- 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))