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Unknown Not applicable

Physical Activity and Fibrosing Interstitial Lung Disease

NCT06182748 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-11-30
Last updated
2024-10-21

Condition(s) studied

Fibrotic Interstitial Lungs Diseases

Investigational drug(s) / intervention(s)

Training on eccentric ergocycleTraining on concentric ergocycle

Training on eccentric ergocycle: Subjects will train on eccentric ergocycles. In eccentric cycling, pedals push against the user's feet in the opposite direction, user has to slow down pedals and quadriceps muscles lengthen during contraction.

Training on concentric ergocycle: Subjects will train on regular concentric ergocycles. In concentric cycling, quadriceps contract to push pedals.

Study summary

Fibrotic interstitial lungs diseases (ILD) are a group of chronic and rare diseases characterized by an altered blood oxygenation in the lung, leading to dyspnea and physical limitation. Physical training is efficient to fight vicious circle of physical deconditioning observed in ILD. Eccentric cycling is an interesting modality of endurance training, allowing better exercise tolerance and adherence while developing cardiorespiratory function. Feasibility and efficacity of eccentric cycling were shown in chronic obstructive pulmonary disease but never in ILD. The primary aim of our work is to compare concentric and eccentric cycling training on physical capacities in ILD. Moreover, we will study the effects of training on the different steps of oxygen transport at exercise, from the lung to the muscles through the blood transport. Our second goal is then to characterize the physiological mechanisms underlying the benefits of exercising in ILD patients. Evaluations will be led during one year to study the long-term effects of training

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient aged ≥ 18 years * Fibrosing PID with fibrosis score \> 10% of lung volume on chest CT scan * Be able to attend physical reconditioning 3 times a week * Be affiliated to a health insurance scheme * Sign informed consent form Exclusion Criteria: * Any contraindication to physical activity (hereafter, after Dany-Michel Marcadeta, Bruno Pavy et al. Recommendations of the French Society of Cardiology for stress tests 2018) * Be unable to perform exercise on an ergocycle or treadmill * Be unable to perform a stress test, particularly for people on long-term oxygen therapy rest oxygen therapy at home * IRS during an exacerbation * Change in treatment \< 3 months * Sarcoidosis * Connectivitis * Pregnancy in progress * Participation in a therapeutic intervention study * Patient under guardianship * Person subject to a legal protection measure * Patient on state medical aid

Primary outcome measure(s)

  • Maximal oxygen uptake (VO2pic) during maximal cardiopulmonary exercise testing on ergocycle — VO2pic will be obtained at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
    VO2pic is the gold standard indicator of cardiorespiratory function. In healthy people, disabled people and patients with ILD, there is a strong correlation between low VO2pic and high risk of mortality and comorbidities. It is often measured during incremental cardiopulmonary exercise testing with gas exchange measurements.Subjects have to cycle until exhaustion. VO2pic is the highest oxygen consumption recorded before test stop.

Trial sites (1)

FacilityCityRegionStatus
Exercise and Sports Medicine Department Bobigny Seine Saint Denis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06182748 on ClinicalTrials.gov ↗ ← All trials in France