Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases
Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Canada
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
RECRUITING
Québec
France
Groupement des Hôpitaux de l'Institut Catholique de Lille
RECRUITING
Lille
FormAction Santé
NOT_YET_RECRUITING
Pérenchies
Contact Information
Primary
Alec Bass, PT, PhD
alec.bass@criucpq.ulaval.ca
418-656-8711
Backup
Marianne Belley
marianne.belley@criucpq.ulaval.ca
418-656-8711
Time Frame
Start Date:2024-02-02
Estimated Completion Date:2026-01
Participants
Target number of participants:82
Treatments
Lab testing (study 1)
Two 3-hour laboratory visits (separated by 6 to 18 days) will be conducted. During the first laboratory visit, anthropometric measurements, pulmonary function tests and CPET on a cycle ergometer will be performed. During the second laboratory visit, spirometry will be repeated to ensure stability of the participants health state (particularly relevant for individuals with COPD). Thereafter, the 6MST and 6MWT will be performed in a randomized order, separated by a rest period of at least 30 minutes.
At home testing (study 2)
Three 1-hour home visits (separated by 2 to 5 days) will be conducted. The first trial of the 6MST (familiarization trial) will be conducted at the participant's home with the therapist present. The second and third trials of the 6MST will be performed in a randomized order, with either direct (therapist present at the home) or remote (therapist present through videoconferencing software, as in a telerehabilitation setting) monitoring.
Collaborators: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) - France