Validation of a home-based exercise test for chronic respiratory diseases
Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases
This study is testing a new home exercise test for people with chronic lung diseases like COPD and ILD to see if it works as well as other tests and if it's safe to do at home.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 82 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Locations | 3 sites (Québec and 2 other locations) |
| Trial ID | NCT06447831 on ClinicalTrials.gov |
What this trial studies
This validation study aims to assess the metrological properties of the 6-minute stepper test in individuals with chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). It will compare the results of the stepper test with the 6-minute walk test and a maximal cardiopulmonary cycling test to determine its validity. Additionally, the study will evaluate the safety and consistency of the stepper test when conducted through direct and remote monitoring methods. Participants will engage in multiple trials of the stepper test, a walk test, and a cycling test, along with semi-structured interviews.
Who should consider this trial
Good fit: Ideal candidates include adults aged 40 and older with a diagnosis of COPD or ILD who have been clinically stable for at least four weeks.
Not a fit: Patients with unstable or severe cardiac conditions, invalidating rheumatologic or neurologic conditions, or those who have recently undergone pulmonary rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the assessment of exercise capacity in patients with chronic respiratory diseases, leading to better management and rehabilitation strategies.
How similar studies have performed: Other studies have shown success in validating exercise tests for chronic respiratory diseases, suggesting that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Québec and 2 other locations
- Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval — Québec, Canada (Recruiting)
- Groupement des Hôpitaux de l'Institut Catholique de Lille — Lille, Hauts-de-France, France (Recruiting)
- FormAction Santé — Pérenchies, Hauts-de-France, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Alec Bass, PT, PhD
- Email: alec.bass@criucpq.ulaval.ca
- Phone: 418-656-8711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.