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Completed

NCT Number: 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

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

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Key information

Conditions

COPD Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval, Québec, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Concurrent validity

    Time frame: Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)

    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

  2. Strength of association between peak cardiorespiratory and symptomology values

    Time frame: Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)

    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

  3. Agreement

    Time frame: Study 1 - Two 3-hour laboratory visits (separated by 6 to 18 days)

    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

  4. Test-restest reliability

    Time frame: Study 2 - Trial 2 and 3 (separated by 2 to 5 days)

    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

Secondary outcomes

  1. Adverse events

    Time frame: Through study completion, an average of 2 years

    All minor and serious adverse events, for all trials, will be reported

  2. Level of comfort during test and perception of safety (qualitative)

    Time frame: Study 2 - Trial 3 (semi-structured interview of 20 to 30 minutes following the completion of the last trial of the 6MST)

    Assessed with thematic content analysis of semi-structured interviews (voice-recorded and transcribed)

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Groupement des Hôpitaux de l'Institut Catholique de Lille
  • Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Registry information

Acronym: 6MST

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 7, 2024
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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