Clinical trial NCT06447831: Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases
Official title: Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD Chronic Obstructive Pulmonary Disease
Interstitial Lung Disease
Keywords: Chronic Obstructive Pulmonary Disease
Exercise Capacity Test
Interstitial Lung Diseases
Physiotherapy
Rehabilitation
Telerehabilitation
Validation Study
Stepper Test
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) - France
First posted: 2024-06-07
Enrollment: 82
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with chronic obstructive pulmonary disease or interstitial lung disease followed in outpatient hospital settings

Brief 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 criteria: Inclusion Criteria:

* Adult ≥ 40 years old
* Diagnosis of chronic obstructive pulmonary disease (GOLDa 2 to 4) or of interstitial lung disease (\&gt; 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

Primary outcomes:
measure: Concurrent validity
timeFrame: Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)
measure: Strength of association between peak cardiorespiratory and symptomology values
timeFrame: Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)
measure: Agreement
timeFrame: Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)
measure: Test-restest reliability
timeFrame: Study 2 - Trial 2 and 3 (separated by 2 to 5 days)
Secondary outcomes:
measure: Adverse events
timeFrame: Through study completion, an average of 2 years
measure: Level of comfort during test and perception of safety (qualitative)
timeFrame: Study 2 - Trial 3 (semi-structured interview of 20 to 30 minutes following the completion of the last trial of the 6MST)
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
city: Lille
country: France
facility: Groupement des Hôpitaux de l'Institut Catholique de Lille
state: Hauts-de-France
city: Pérenchies
country: France
facility: FormAction Santé
state: Hauts-de-France
Study officials:
References: