Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases

Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases

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

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