- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Quebec
-
Québec, Quebec, Canada, G1V 4G5
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Placebo
|
placebo [NaCl]
|
Sperimentale: Fentanil
|
Single-dose of intrathecal fentanyl [25ug] Duration of fentanyl : 3.5 hours
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Endurance time
Lasso di tempo: 60-min post-anesthesia - From the start to the end of the constant-workload cycling test (limited by symptoms of the patients)
|
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)
|
60-min post-anesthesia - From the start to the end of the constant-workload cycling test (limited by symptoms of the patients)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Ventilatory response
Lasso di tempo: 60-min post-anesthesia-From the start to the end of the constant-workload cycling test (limited by symptoms of the patients)
|
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
Lasso di tempo: 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.
|
15-min after the end of constant-workload cycling test
|
Dynamic hyperinflation
Lasso di tempo: 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
|
Effort perception
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: François Maltais, MD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Malattie polmonari
- Malattie polmonari, ostruttive
- Malattia polmonare, cronica ostruttiva
- Effetti fisiologici delle droghe
- Depressori del sistema nervoso centrale
- Agenti del sistema nervoso periferico
- Analgesici
- Agenti del sistema sensoriale
- Anestetici, per via endovenosa
- Anestetici, Generale
- Anestetici
- Analgesici, oppioidi
- Narcotici
- Adiuvanti, Anestesia
- Fentanil
Altri numeri di identificazione dello studio
- SPINAL-20520
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Fentanyl
-
Janssen Research & Development, LLCCompletato
-
Mylan Pharmaceuticals IncTerminato
-
University of Texas Southwestern Medical CenterCompletato
-
Mylan Pharmaceuticals IncCompletato
-
Janssen Pharmaceutical K.K.Completato
-
Meir Medical CenterCompletatoDelirio in Terapia IntensivaIsraele
-
Columbia UniversityRitiratoDolore del travaglioStati Uniti
-
Hamad Medical CorporationNon ancora reclutamento
-
Postgraduate Institute of Medical Education and...CompletatoAnestesia Emergenza DeliriumIndia
-
Kanuni Sultan Suleyman Training and Research HospitalCompletatoSedazione moderata non riuscita durante la procedura