|

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

RECRUITINGSponsored by Laval University
Actively Recruiting
SponsorLaval University
Started2024-02-02
Est. completion2026-01
Eligibility
Age40 Years+
Healthy vol.Accepted

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

Eligibility

Age: 40 Years+Healthy volunteers accepted
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

Conditions3

COPDCOPD - Chronic Obstructive Pulmonary DiseaseInterstitial Lung Disease

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.