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A constant load exercise during 10 minutes will be performed in a group of Chronic Obstructive Pulmonary Disease patients, in a basal condition (spontaneous breathing); under noninvasive mask ventilation and with high flow nasal cannula. With the aim of reducing dyspnea, increasing exercise tolerance, and unload respiratory muscles, three exercises will be compared in terms of use of respiratory muscles and neural drive measured with paraesternal electromyography.
Exercise in chronic obstructive pulmonary disease is limited by dynamic hyperinflation and respiratory muscle overloadleading to severe dyspnea. During exercise, the increase in neural respiratory drive is notable to match ventilatory demand, correlated with breathlessness. Non-Invasive Ventilation may improve neural respiratory drive uncoupling and exercise tolerance. The aim of this study will be prove if Non-Invasive Ventilation and High flow nasal cannula during exercise reduces neural respiratory drive and improves dyspnea, measured with paraesternal electromyography
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | All patients will be performed a basal test that consist on continuous cyclergometer exercise, under constant load, with spontaneous breathing, after that the same exercise protocol performed will be carried out under non-invasive ventilation (NIV test). Parameters will be titrated previosuly. Finally the patient will perform the same exercise at a constant load under high flow oxygen therapy ( HFNC test). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise with spontaneous ventilation. | Other | Patients will perform 10 minutes, constant load, exercise in a cycloergometer. To set the load, a baseline incremental effort test will be performed previously (VISIT 1). Then, in a separate day (VISIT 2), the subject will perform 10 minutes cycling at the 75% load of that determined as maximum in VISIT 1, at a constant rate of 30 to 35 pedal revolutions per minute, in spontaneous breathing, with low flow oxygen through conventional nasal cannula adjusted to achieve SpO2 between 92to 94% |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Neural ventilator (NVU) (%) | the peak value (on the baseline) of the maximum muscle activity ( Root mean square EMG value in mV), both diaphragmatic (EMGDimax) and parasternal (EMGparamax) in the máximum intentional ventilation and maximum inspiratory peak (MIP) will be taken. This value will be consider 100% and based on this mean EMG will be calculate for a normalized EMGdi (RMS) and paraesternal in each ventilatory situation (spontaneous ventilation or under NIV). At each effort point (in each minute of the exercise protocol), the relationship between the normalized EMG value (parasternal and Diaphragmatic) and the tidal volume (obtained by integral of flow signal by means of a pneumotachograph connected to the VM -in NIV- or oronasal hermetic mask -in Vesp). To facilitate the interpretation of the expired TV, the mask without leakage will be used with the intentional leak connected in the circuit, before the pneumotachograph. | 24 hours, 48 hours, 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Borg Scale Dyspnea evolution (points) | Degree of dyspnea will be determined by this validated scale with a result between 1 and 10 points.0: Not at all 0.5: Very, very light (hardly noticeable) 1: Very light, 2: Light, 3: Moderate , 4: Somewhat intense, 5: Intense, 6: Between 5 and 7, 7: Very intense, 8: Between 7 and 9, 9: Very, very intense (almost maximum ), 10: Maximum | Basal value at day 1 and every 60 seconds during the exercise |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recluted from the pneumology outpatient clinic of the Hospital 12 de Octubre
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| Name | Affiliation | Role |
|---|---|---|
| Javier Sayas | Hospital 12 de OCtubre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Javier Sayas Catalan | Madrid | 28041 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38829281 | Derived | Sayas J, Lalmolda C, Corral M, Florez P, Hernandez-Voth A, Janssens JP, Rabec C, Langevin B, Lofaso F, Carlucci A, Llontop C, Winck JC, Bermejo JG, Lujan M. Measurement of thoraco-abdominal synchrony using respiratory inductance plethysmography: technical aspects and a proposal to overcome its limitations. Expert Rev Respir Med. 2024 Mar-Apr;18(3-4):227-236. doi: 10.1080/17476348.2024.2363058. Epub 2024 Jun 7. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 23, 2019 | Sep 3, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D005081 | Exercise Therapy |
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Exercise with NIV | Device | VISIT 2 Non invasive mask ventilation: parameters will be titrated during a free cycling period at the end of the spontaneous breathing exercise. Then, in a separate day (VISIT 3), with the same constant load, cycling cadence and under NIV, the patient will perform 10 min of cycling. |
|
| Exercise with HFNC | Device | With constant flows of 50 lpm and with FiO2 adjusted according to SPO2, to obtain a constant saturation between 92 and 94%. The same pedaling load and frequency will be maintained, with similar variables collected. |
|
| Borg Scale Dyspnea evolution (points) | Degree of dyspnea will be determined by this validated scale with a result between 1 and 10 points.0: Not at all 0.5: Very, very light (hardly noticeable) 1: Very light, 2: Light, 3: Moderate , 4: Somewhat intense, 5: Intense, 6: Between 5 and 7, 7: Very intense, 8: Between 7 and 9, 9: Very, very intense (almost maximum ), 10: Maximum | 24 hours later than day 1 (day 2) during the exercise every 60 seconds |
| Borg Scale Dyspnea evolution (points) | Degree of dyspnea will be determined by this validated scale with a result between 1 and 10 points.0: Not at all 0.5: Very, very light (hardly noticeable) 1: Very light, 2: Light, 3: Moderate , 4: Somewhat intense, 5: Intense, 6: Between 5 and 7, 7: Very intense, 8: Between 7 and 9, 9: Very, very intense (almost maximum ), 10: Maximum | 48 hours later than day 1 (day 3) during the exercise every 60 seconds |
| Borg Scale Dyspnea evolution (points) | Degree of dyspnea will be determined by this validated scale with a result between 1 and 10 points.0: Not at all 0.5: Very, very light (hardly noticeable) 1: Very light, 2: Light, 3: Moderate , 4: Somewhat intense, 5: Intense, 6: Between 5 and 7, 7: Very intense, 8: Between 7 and 9, 9: Very, very intense (almost maximum ), 10: Maximum | 72 hours later than day 1 (day 4) during the exercise every 60 seconds |
| Transcutaneous pCO2 Final - inicial (mmHg) | Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2) | Basal value at day 1 during the exercise |
| Transcutaneous pCO2 Final - inicial (mmHg) | Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2) | During the exercise at day 2 ( 24 hours later than day 1) |
| Transcutaneous pCO2 Final - inicial (mmHg) | Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2) | During the exercise at day 3 (48 hours later than day 1) |
| Transcutaneous pCO2 Final - inicial (mmHg) | Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2) | During the exercise at day 4 (72 hours later than day 1 ) |
| Total Training time (pedaling, minutes) | Total Time that the patient remains pedaling | During the exercise at day 2 ( 24 hours later than day 1) |
| Total Training time (pedaling, minutes) | Total Time that the patient remains pedaling | During the exercise at day 3 ( 48 hours later than day 1) |
| Total Training time (pedaling, minutes) | Total Time that the patient remains pedaling | During the exercise at day 4 ( 72 hours later than day 1) |
| Stops (n) | Number of stops that the patient performs during the test | During the exercise at day 2 ( 24 hours later than day 1) |
| Stops (n) | Number of stops that the patient performs during the test | During the exercise at day 3 ( 48 hours later than day 1) |
| Stops (n) | Number of stops that the patient performs during the test | During the exercise at day 4 ( 72 hours later than day 1) |
| Ineffective efforts % | Porcentage of ineffective efforts during the exercise | During the exercise at day 2 ( 24 hours later than day 1) |
| Ineffective efforts % | Porcentage of ineffective efforts during the exercise | During the exercise at day 3 ( 48 hours later than day 1) |
| Ineffective efforts % | Porcentage of ineffective efforts during the exercise | During the exercise at day 4 ( 72 hours later than day 1) |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D012138 | Respiratory Therapy |