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NCT07125989Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 15 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
4 Aug 2025
Start date
1 Oct 2025
Primary completion date
Jan 2027
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Diseases
COPD
NCT number
NCT07125989

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 1 Oct 2025 to the primary completion date, Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Cerebrospinal fluid leak, recent head trauma, or cranial surgery

Other illness

  • Severe unstable cardiac disease
  • Severe bulbar disorder
  • Severe orthopedic or neurological disorder compromising rehabilitation.

Other

  • BMI \> 35
  • Recent acute respiratory exacerbation \< 4 weeks
  • Pneumothorax or pneumomediastinum
  • Pathological hypotension
  • Dehydration
  • Patient deprived of liberty or patient under guardianship
  • Pregnant woman

Who the study is looking for

  • -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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU de Sint-Etienne
Coordinator of this site? Confirm its status
Saint-EtienneFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.