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)

Laval University

Status: Enrolling

Conditions: COPD Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease

Study type: Observational

Funder types: Other

Identifiers

NCT06447831

2024-4075, 22380

Details and patient eligibility

About

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

Enrollment: 82 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

82 participants in 2 patient groups

Lab testing (study 1)

Description:

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)

Description:

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.