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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01522729
Impact of Muscle Afferent Feedback During Exercise in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Impact of Somatosensory Feedback on Peripheral Muscle Fatigue and Exercise Tolerance in Patients With COPD
Recently, direct evidences point to the contributing role of peripheral muscle fatigue in exercise tolerance among patients with COPD. However, the physiological mechanisms by which peripheral muscle fatigue impairs exercise tolerance are still unknown, as factors regulating peripheral muscle fatigue in COPD may be complex. One possible link between limb muscle fatigue and exercise intolerance could be enhanced afferent signals from the active limb muscles to the central command, thereby limiting central motor output and eventually leading to exercise termination.
A direct method to investigate the regulation of peripheral muscle fatigue during exercise in patients with COPD is the blockade of peripheral neural afferents via lumbar anesthesia. Consequently, investigating the interplay between the peripheral muscular component and the central motor command during self-paced exercise could shed light on the regulation of peripheral muscle fatigue in COPD and its implication in exercise intolerance.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The aim of the study is to characterize the role of peripheral muscle afferents on the development of muscle fatigue, cardiorespiratory response and exercise tolerance to constant-workrate endurance cycling exercise in patients with COPD.
In a double-blind randomized design, patients with GOLD stage II-III COPD will be recruited and will complete a constant-workrate cycling test following either the injection of a placebo [NaCl, interspinous L2-L3] or an opioid [Fentanyl 25 µg, intrathecal L2-L3] inhibiting central feedback of peripheral muscles sensory afferents. Quadriceps force (TwQ) will be measured by magnetic stimulation of the femoral nerve and central chemoreceptors response will be assessed by CO2 rebreathing, both performed before and after the injection. Finally, TwQ will also be measured after the endurance cycling test to assess the magnitude of quadriceps fatigue induced by symptom-limited exercise.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Quebec
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Québec, Quebec, Canadá, G1V 4G5
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Smoking history > 15 pack-years
- COPD GOLD II-III (30 % predicted < FEV1 < 80 % predicted; FEV1/FVC < 0.70)
Exclusion Criteria:
- Unstable condition
- Recent exacerbation (<3 months)
- Recent cancer (<3 months)
- Myopathy, neuromuscular disease
- Unstable cardiac disease
- Hepatic, kidney, intestinal disease
- BMI > 35
- PaCO2 > 45 mmHg
- PaO2 < 60 mmHg
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Placebo
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placebo [NaCl]
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Experimental: Fentanilo
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Single-dose of intrathecal fentanyl [25ug] Duration of fentanyl : 3.5 hours
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Endurance time
Periodo de tiempo: 60-min post-anesthesia - From the start to the end of the constant-workload cycling test (limited by symptoms of the patients)
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Exercise tolerance is referred as the endurance time (sec) during constant-workrate cycling test at 80 % of the predetermined maximal workload in every conditions (placebo and fentanyl)
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60-min post-anesthesia - From the start to the end of the constant-workload cycling test (limited by symptoms of the patients)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Ventilatory response
Periodo de tiempo: 60-min post-anesthesia-From the start to the end of the constant-workload cycling test (limited by symptoms of the patients)
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The ventilatory response (Ventilation, L/min) will be monitored continuously during the cycling test and will be compared between the two conditions (placebo vs. fentanyl)
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60-min post-anesthesia-From the start to the end of the constant-workload cycling test (limited by symptoms of the patients)
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Quadriceps muscle fatigue
Periodo de tiempo: 15-min after the end of constant-workload cycling test
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The quadriceps muscle fatigue will be monitored before and after the cycling test to quantify the extent of muscle fatigue produced by the cycling test.
This will be done by magnetic stimulation of the femoral nerve and maximal voluntary contraction.
Also, non-invasive surface electromyography (EMG) of the quadriceps will help to better characterize muscle fatigue.
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15-min after the end of constant-workload cycling test
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Dynamic hyperinflation
Periodo de tiempo: 60-min post-anesthesia-From the start to the end of the constant-workload cycling test (limited by symptoms of the patients) - Every 2-min during exercise
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Dynamic hyperinflation will be monitored periodically every 2-min during the cycling test by manoeuvres of inspiratory capacity and will be compared between the two conditions (placebo vs. fentanyl)
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60-min post-anesthesia-From the start to the end of the constant-workload cycling test (limited by symptoms of the patients) - Every 2-min during exercise
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Effort perception
Periodo de tiempo: 60-min post-anesthesia-From the start to the end of the constant-workload cycling test (limited by symptoms of the patients) - Every 2-min during exercise
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Leg fatigue and dyspnea perception (Borg scale scores) will be monitored periodically every 2-min during the cycling test and will be compared between the two conditions (placebo vs. fentanyl)
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60-min post-anesthesia-From the start to the end of the constant-workload cycling test (limited by symptoms of the patients) - Every 2-min during exercise
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: François Maltais, MD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Enfermedades Pulmonares Obstructivas
- Enfermedad Pulmonar Obstructiva Crónica
- Efectos fisiológicos de las drogas
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Anestésicos Intravenosos
- Anestésicos Generales
- Anestésicos
- Analgésicos Opiáceos
- Estupefacientes
- Adyuvantes, Anestesia
- Fentanilo
Otros números de identificación del estudio
- SPINAL-20520
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