Actively Recruiting

Age: 40Years +
All Genders
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

Led by Laval University · Updated on 2024-06-07

82

Participants Needed

3

Research Sites

99 weeks

Total Duration

On this page

Sponsors

L

Laval University

Lead Sponsor

I

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Collaborating Sponsor

AI-Summary

What this Trial Is 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

CONDITIONS

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 40 years or older
  • Diagnosis of chronic obstructive pulmonary disease (GOLD 2 to 4) or interstitial lung disease for more than 6 months
  • Clinically stable for at least 4 weeks
Not Eligible

You will not qualify if you...

  • Interstitial lung disease linked to connective tissue disease or sarcoidosis
  • Unstable or severe heart conditions
  • Rheumatologic or neurologic conditions that cause disability
  • Weight above the exercise equipment limit (e.g., over 130 kg for the stepper)
  • Any physical condition that limits or prevents exercise testing
  • Participation in another study requiring medication changes
  • Pulmonary rehabilitation within the past year
  • Use of oxygen therapy for arm 1 participants (due to inability to perform gas analysis)
  • Participation in arm 1 for arm 2 participants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval

Québec, Canada, G1V 4G5

Actively Recruiting

2

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lille, Hauts-de-France, France, 59000

Actively Recruiting

3

FormAction Santé

Pérenchies, Hauts-de-France, France, 59840

Not Yet Recruiting

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Research Team

A

Alec Bass, PT, PhD

CONTACT

M

Marianne Belley

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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