Informations générales (source: ClinicalTrials.gov)

NCT06447831 En recrutement
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)
Observational
  • Maladies pulmonaires
  • Bronchopneumopathies obstructives
  • Troubles respiratoires
  • Maladies de l'appareil respiratoire
  • Pneumopathies interstitielles
  • Broncho-pneumopathie chronique obstructive
Laval University (Voir sur ClinicalTrials)
février 2024
janvier 2026
29 juin 2024
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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Etablissements

Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
FormAction Santé - 59840 - Pérenchies - Hauts-de-France - France Sarah Géphine, PhD Recrutement non commencé Contact (sur clinicalTrials)
Groupement des Hôpitaux de l'Institut Catholique de Lille - 59000 - Lille - Hauts-de-France - France Sarah Géphine, PhD En recrutement Contact (sur clinicalTrials)

Critères

Tous
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


- 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