NCT06447831|Completed
Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases
6MST
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6MST
Sponsor study identifier
observational
89
2 countries
3
Study Start
February 2, 2024
Actual (reported)Primary Completion
June 1, 2025
Actual (reported)Study Completion
June 1, 2025
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2, 2024
Actual (reported)February 2, 2024
Actual (reported)June 7, 2024
Actual (reported)June 1, 2025
Actual (reported)June 1, 2025
Actual (reported)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)
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)
Agreement
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.
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.
Individuals with chronic obstructive pulmonary disease or interstitial lung disease followed in outpatient hospital settings
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
Québec, Quebec, G1V 4G5, Canada
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lille, Hauts-de-France, 59000, France
FormAction Santé
Pérenchies, Hauts-de-France, 59840, France
Bass A, Gephine S, Martin M, Belley M, Robic M, Fabre C, Grosbois JM, Dion G, Saey D, Chambellan A, Maltais F. Assessing Functional Capacity in Directly and Remotely Monitored Home-Based Settings in Individuals With Chronic Respiratory Diseases: Protocol for a Multinational Validation Study. JMIR Res Protoc. 2024 Jun 28;13:e57404. doi: 10.2196/57404.
89 participants (actual enrollment reported by the registry).
First Submitted
February 2, 2024
First Posted
June 7, 2024
Study Start
February 2, 2024
Actual (reported)NIVATS Versus IGAVATS: a Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases
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)
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)
Adverse events
Through study completion, an average of 2 years
Level of comfort during test and perception of safety (qualitative)
Study 2 - Trial 3 (semi-structured interview of 20 to 30 minutes following the completion of the last trial of the 6MST)
Contact the study team to confirm eligibility.
Primary Completion
June 1, 2025
Actual (reported)Study Completion
June 1, 2025
Actual (reported)Last Updated
August 26, 2026
Record last verified: 2025-08
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