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

Interstitial Lung Disease Clinical Trial

— 6MST  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06447831
• Other study ID #: 2024-4075, 22380
• Status: Recruiting
• Start date: February 2, 2024
• Est. completion date: January 2026

Study information

• Verified date: June 2024
• Source: Laval University
• Contact: Alec Bass, PT, PhD
• Phone: 418-656-8711
• Email: alec.bass[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD Chronic Obstructive Pulmonary Disease
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiration Disorders
• Respiratory Tract Diseases

Locations

Country	Name	City	State
Canada	Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval	Québec
France	Groupement des Hôpitaux de l'Institut Catholique de Lille	Lille	Hauts-de-France
France	FormAction Santé	Pérenchies	Hauts-de-France

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) - France, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concurrent validity	Assessed using paired sample t-tests (or Wilcoxon signed-rank tests) to verify whether peak cardiorespiratory (e.g., oxygen consumption, minute ventilation, heart rate, etc.) and symptomology (i.e., dyspnea and leg fatigue) values obtained during the 6-minute stepper test are comparable to the maximal cardiopulmonary test and the 6-minute walk test	Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)
Primary	Strength of association between peak cardiorespiratory and symptomology values	Pearson's correlation coefficients (r) will be calculated between the number of steps taken during the 6-minute stepper test and peak oxygen consumption and heart rate reached during all three tests	Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)
Primary	Agreement	Assessed with Bland-Altman plots and 95% limits of agreement (mean difference ± 1.96 standard deviation of the difference) between peak cardiorespiratory and symptomology values reached during the 6-minute stepper test and those reached during the maximal cardiopulmonary test and the 6-minute walk test	Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)
Primary	Test-restest reliability	Reliability (trial 2 versus 3 = directly versus remotely monitored) will be assessed using paired sample t-tests (or Wilcoxon signed-rank tests), Bland-Altman plots (with 95% limits of agreement), and intraclass correlations	Study 2 - Trial 2 and 3 (separated by 2 to 5 days)
Secondary	Adverse events	All minor and serious adverse events, for all trials, will be reported	Through study completion, an average of 2 years
Secondary	Level of comfort during test and perception of safety (qualitative)	Assessed with thematic content analysis of semi-structured interviews (voice-recorded and transcribed)	Study 2 - Trial 3 (semi-structured interview of 20 to 30 minutes following the completion of the last trial of the 6MST)