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

NCT06447831 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 82

Last updated 2024-06-07

No results posted yet for this study

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

Conditions

Sponsors & Collaborators

  • Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

    collaborator OTHER
  • Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) - France

    collaborator UNKNOWN
  • Laval University

    lead OTHER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-02
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • Canada
  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06447831 on ClinicalTrials.gov