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NCT Number: NCT07125989

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Sint-Etienne

Saint-Etienne, 42055, France

Location contact

Frederic ROCHE, MD-PhD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Pedaling time limit (in seconds)

    Time frame: 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.

Secondary outcomes

  1. Partial pressure of oxygen (PaO2) in mmHg

    Time frame: Day 1, Day 3, Day 5

    PaO2 measured by capillary blood gas analysis performed at peak exercise during a respiratory rehabilitation session

  2. Partial pressure of carbon dioxide (PaCO2) in mmHg

    Time frame: Day 1, Day 3, Day 5

    PaCO2 measured by capillary blood gas analysis performed at peak exercise during a respiratory rehabilitation session

  3. Lactate in mmol/l

    Time frame: Day 1, Day 3, Day 5

    Lactate measured by capillary blood gas analysis performed at peak exercise during a respiratory rehabilitation session

  4. Peripheral muscle oxygenation (% SmO2)

    Time frame: Day 1, Day 3, Day 5

    Measurement of peripheral muscle oxygenation (% SmO2) using near-infrared spectroscopy (NIRS) during exercise in an endurance test during a respiratory rehabilitation session.

Study contacts

Contact information is provided by the study sponsor or research team.

Frédéric ROCHE, MD-PhD

CONTACT

[email protected]

+33(0)477829109

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: AVE-BPCO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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