- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Quebec
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Québec, Quebec, Canada, G1V 4G5
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Placebo
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placebo [NaCl]
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Expérimental: Fentanyl
|
Single-dose of intrathecal fentanyl [25ug] Duration of fentanyl : 3.5 hours
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Endurance time
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Ventilatory response
Délai: 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)
|
60-min post-anesthesia-From the start to the end of the constant-workload cycling test (limited by symptoms of the patients)
|
|
Quadriceps muscle fatigue
Délai: 15-min after the end of constant-workload cycling test
|
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
|
|
Dynamic hyperinflation
Délai: 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
|
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)
|
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
Délai: 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
|
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)
|
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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: François Maltais, MD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Maladies pulmonaires
- Maladies pulmonaires obstructives
- Maladie pulmonaire obstructive chronique
- Effets physiologiques des médicaments
- Dépresseurs du système nerveux central
- Agents du système nerveux périphérique
- Analgésiques
- Agents du système sensoriel
- Anesthésiques intraveineux
- Anesthésiques, général
- Anesthésiques
- Analgésiques, Opioïdes
- Stupéfiants
- Adjuvants, Anesthésie
- Fentanyl
Autres numéros d'identification d'étude
- SPINAL-20520
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