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Starting soon Not applicable

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

NCT07125989 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-10-01
Last updated
2025-08-15

Condition(s) studied

Chronic Obstructive Pulmonary Disease (COPD)

Investigational drug(s) / intervention(s)

non-invasive ventilation

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).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * -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 Criteria: * BMI \> 35 * Recent acute respiratory exacerbation \< 4 weeks * Severe unstable cardiac disease * Pneumothorax or pneumomediastinum * Pathological hypotension * Cerebrospinal fluid leak, recent head trauma, or cranial surgery * Severe bulbar disorder * Dehydration * Severe orthopedic or neurological disorder compromising rehabilitation. * Patient deprived of liberty or patient under guardianship * Pregnant woman

Primary outcome measure(s)

  • Pedaling time limit (in seconds) — Day 1, Day 3, Day 5
    Endurance capacity will be measured by the time limit for pedaling (in seconds) on a cycloergometer, performed during a respiratory rehabilitation session, at 70% of the maximum power developed during the maximum test.

Trial sites (1)

FacilityCityRegionStatus
CHU de Sint-Etienne Saint-Etienne France
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 NCT07125989 on ClinicalTrials.gov ↗ ← All trials in France