NCT07125989

Effect of Exercise Ventilatory Support Pressure on Endurance in Patients With Severe Chronic Obstructive Pulmonary Disease - AVE-BPCO

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease characterized by progressive obstruction of the airways. In advanced stages, it can progress to chronic respiratory failure with major respiratory repercussions. Biologically, hyperinflation manifests as alveolar hypoventilation, which causes hypercapnia. Mechanically, it is responsible for an increase in ventilatory work associated with diaphragmatic muscle dysfunction and fatigue, leading to exercise incapacity. Physical inactivity is a major predictor of mortality in patients with COPD. The recommendations of the European Respiratory Society (ERS) and the American Thoracic Society (ATS) emphasize the importance of exercise in the treatment and management of COPD. Respiratory rehabilitation has been shown to have an indisputable effect on dyspnea and the quality of life of COPD patients. Current guidelines for respiratory rehabilitation recommend interventions at a frequency of at least 2 to 3 supervised high-intensity training sessions per week. A minimum of 4 weeks of physical training is necessary to achieve a significant improvement in quality of life, dyspnea, and endurance. A reduction in the duration and intensity of sessions is often necessary, thus limiting the desired benefits of respiratory rehabilitation. Non-invasive ventilation (NIV) provides mechanical respiratory assistance by helping inspiration and optimizing expiration through a non-invasive interface such as a mask. Its use during exercise in severe COPD is to try to correct hypercapnia, reduce dynamic hyperinflation by helping the respiratory muscles to improve their work, and reduce dyspnea and the feeling of muscle weakness. However, the modalities in terms of ventilation mode and inspiratory support pressures are not clearly established.

Detailed description

The objective of this study is therefore to compare different levels of ventilatory assistance during exercise to determine whether the level of inspiratory assistance during exercise significantly improves endurance in these patients and, in particular, whether high-intensity ventilatory assistance (inspiratory assistance 21 +/- 3 cmH20) provides a greater benefit in terms of endurance time compared to moderate intensity (inspiratory assistance 13 +/- 3 cmH20) or low intensity (inspiratory assistance \< 6 cmH20).

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DEVICE	non-invasive ventilation	During the patient's first three respiratory rehabilitation sessions, each test on the cycle ergometer will be performed at 70% of maximum power (defined during the initial oxygen consumption (VO2) test) with ventilatory assistance at a different intensity (Low, moderate or high intensity).

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-08-15
• Last updated: 2025-08-15

Locations

1 site across 1 country: France