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

NCT07125989 | Not Yet Recruiting

• 2 other identifiers: 24CH1262025-A00555-44
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic obstructive pulmonary disease; respiratory rehabilitation; non-invasive ventilation

Outcome Measures

Primary Outcomes (1)

• Pedaling time limit (in seconds)

  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.

  Day 1, Day 3, Day 5

Secondary Outcomes (4)

• Partial pressure of oxygen (PaO2) in mmHg

  Day 1, Day 3, Day 5

• Partial pressure of carbon dioxide (PaCO2) in mmHg

  Day 1, Day 3, Day 5

• Lactate in mmol/l

  Day 1, Day 3, Day 5

• Peripheral muscle oxygenation (% SmO2)

  Day 1, Day 3, Day 5

Study Arms (3)

Low intensity

SHAM COMPARATOR

Non-invasive ventilation less han 6 cmH2O

Device: non-invasive ventilation

Moderate intensity

ACTIVE COMPARATOR

Non-invasive ventilation 13 +/-3 cmH2O

Device: non-invasive ventilation

High intensity

EXPERIMENTAL

Non-invasive ventilation 21 +/-3 cmH2O

Device: non-invasive ventilation

Interventions

non-invasive ventilation 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; Low intensity; Moderate intensity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Sint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Frédéric ROCHE, MD-PhD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric ROCHE, MD-PhD

CONTACT

+33(0)477829109; frederic.roche@univ-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 15, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

FR (1)