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Tests breathing support pressure during exercise in severe chronic obstructive pulmonary disease

Tests breathing-mask support during exercise in adults with severe COPD.

Plain-language title generated from the registry record
Registry title: Effect of Exercise Ventilatory Support Pressure on Endurance in Patients With Severe Chronic Obstructive Pulmonary Disease - AVE-BPCO

Key facts

Where
Saint-Etienne, FranceSee the site

Where in France

  • CHU de Sint-EtienneSaint-Etienne, FranceNo longer taking part

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Trial details

Who runs it
Centre Hospitalier Universitaire de Saint Etienne
Trial code
NCT07125989
Record updated
15 August 2025
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: -COPD stage GOLD III or IV; Baseline hypercapnia PaCO2 > 45 mmHg OR Alveolar hypoventilation during exercise (increase in PaCO2 > 5 mmHg),; Exhaustion of more than 80% of ventilatory reserve OR max power < 50 Watts; Affiliation or entitlement to social security coverage; Signature of informed consent.

Exclusion: Cerebrospinal fluid leak, recent head trauma, or cranial surgery; Severe unstable cardiac disease; Severe bulbar disorder; Severe orthopedic or neurological disorder compromising rehabilitation; BMI > 35; Recent acute respiratory exacerbation < 4 weeks; Pneumothorax or pneumomediastinum; Pathological hypotension; Dehydration; Patient deprived of liberty or patient under guardianship; Pregnant woman.

ClinicalTrials.gov NCT07125989