Actively Recruiting
Led by Laval University · Updated on 2024-06-07
82
Participants Needed
3
Research Sites
N/A
Total Duration
L
Laval University
Lead Sponsor
I
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Collaborating Sponsor
This research aims to evaluate the 6-minute stepper test in adults aged 40 and older who have chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD). The study seeks to determine if the stepper test is valid compared to the 6-minute walk test and a maximal cardiopulmonary cycling test, whether the results are consistent when monitored directly in person or remotely via videoconferencing, and if the test is safe when performed at home with either monitoring method. Participants will attend two separate 3-hour laboratory visits where measurements like lung function and a cardiopulmonary exercise test on a cycle ergometer will be performed. They will also perform the 6-minute stepper test and the 6-minute walk test in random order with rest periods in between. Additionally, participants will have three 1-hour home visits to perform multiple stepper test trials; the first with a therapist present, and the next two either with direct or remote monitoring in random order. During the study, participants' health status and lung function will be monitored to ensure stability. The researchers will assess the validity and reliability of the stepper test by comparing it with other exercise tests and check for any adverse events. Participants will also provide feedback in interviews about their comfort and sense of safety while doing the stepper test. The study involves assessments over a period that may last up to two years for safety monitoring.
CONDITIONS
Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 18 days
Participants undergo laboratory testing including anthropometric measurements, pulmonary function tests, cardiopulmonary exercise testing, and spirometry to assess functional capacity.
Two 3-hour laboratory visits
Duration - 6 to 18 days
Participants perform the 6-minute step test (6MST) and 6-minute walk test (6MWT) in randomized order with rest periods to validate functional capacity measures.
Included in laboratory visits
Duration - 4 to 10 days
Participants complete three 1-hour home visits to perform the 6MST under direct or remote monitoring to assess test-retest reliability and perception of safety.
Three 1-hour home visits
Duration - Approximately 2 years
Participants are observed for adverse events and comfort during testing over an average of 2 years.
Follow-up contacts as needed
Total: 3 locations
1
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
Québec, Canada, G1V 4G5
Actively Recruiting
2
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lille, Hauts-de-France, France, 59000
Actively Recruiting
3
FormAction Santé
Pérenchies, Hauts-de-France, France, 59840
Not Yet Recruiting
A
Alec Bass, PT, PhD
M
Marianne Belley
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Alec Bass, Sarah Géphine, Mickaël Martin...
https://pubmed.ncbi.nlm.nih.gov/38941132