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

NCT ID: NCT07125989

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-01-31

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low intensity

Non-invasive ventilation less han 6 cmH2O

Group Type: SHAM_COMPARATOR

non-invasive ventilation

Intervention Type: DEVICE

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).

Moderate intensity

Non-invasive ventilation 13 +/-3 cmH2O

Group Type: ACTIVE_COMPARATOR

non-invasive ventilation

Intervention Type: DEVICE

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).

High intensity

Non-invasive ventilation 21 +/-3 cmH2O

Group Type: EXPERIMENTAL

non-invasive ventilation

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric ROCHE, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU de Sint-Etienne

Saint-Etienne, , France

Countries

France

Central Contacts

Frédéric ROCHE, MD-PhD

Role: CONTACT

frederic.roche@univ-st-etienne.fr

+33(0)477829109

Other Identifiers

2025-A00555-44

Identifier Type: OTHER

Identifier Source: secondary_id

24CH126

Identifier Type: -

Identifier Source: org_study_id