Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Chronic obstructive pulmonary disease, respiratory rehabilitation, non-invasive ventilation
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).
Interventions
DEVICEnon-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).
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Partial pressure of oxygen (PaO2) in mmHg | Day 1, Day 3, Day 5 | PaO2 measured by capillary blood gas analysis performed at peak exercise during a respiratory rehabilitation session |
| Partial pressure of carbon dioxide (PaCO2) in mmHg | Day 1, Day 3, Day 5 | PaCO2 measured by capillary blood gas analysis performed at peak exercise during a respiratory rehabilitation session |
| Lactate in mmol/l | Day 1, Day 3, Day 5 | Lactate measured by capillary blood gas analysis performed at peak exercise during a respiratory rehabilitation session |
| Peripheral muscle oxygenation (% SmO2) | 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. |
Countries
France
Contacts
Primary ContactFrédéric ROCHE, MD-PhD
Outcome results
None listed