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)

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

Study Overview

• Status: Recruiting
• Conditions: Interstitial Lung Disease; COPD Chronic Obstructive Pulmonary Disease

• Study Type: Observational
• Enrollment (Estimated): 82

Contacts and Locations

• Study Contact: Name: Alec Bass, PT, PhD; Phone Number: 3012 418-656-8711; Email: alec.bass@criucpq.ulaval.ca
• Study Contact Backup: Name: Marianne Belley; Phone Number: 5882 418-656-8711; Email: marianne.belley@criucpq.ulaval.ca

Study Locations

• Canada
  • Québec, Canada, G1V 4G5
    • Recruiting
    • Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
    • Principal Investigator: François Maltais, MD
    • Contact: Alec Bass, PT, PhD; Phone Number: 3012 418-656-8711; Email: alec.bass@criucpq.ulaval.ca
    • Contact: Marianne Belley, BSc; Phone Number: 5882 418-656-8711; Email: marianne.belley@criucpq.ulaval.ca
• France
  • Hauts-de-France
    • Lille, Hauts-de-France, France, 59000
      • Recruiting
      • Groupement des Hôpitaux de l'Institut Catholique de Lille
      • Contact: Sarah Géphine, PhD; Phone Number: 076-680-2113; Email: sarah.gephine@univ-lille.fr
      • Principal Investigator: Arnaud CHAMBELLAN, MD
    • Pérenchies, Hauts-de-France, France, 59840
      • Not yet recruiting
      • FormAction Santé
      • Contact: Sarah Géphine, PhD; Phone Number: 076-680-2113; Email: sarah.gephine@univ-lille.fr
      • Principal Investigator: Jean-Marie Grosbois, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals with chronic obstructive pulmonary disease or interstitial lung disease followed in outpatient hospital settings

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	All minor and serious adverse events, for all trials, will be reported	Through study completion, an average of 2 years
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)

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval; Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) - France

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Telerehabilitation; Physiotherapy; Chronic Obstructive Pulmonary Disease; Validation Study; Interstitial Lung Diseases; Stepper Test; Exercise Capacity Test
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 2024-4075, 22380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No