- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Quebec
-
Québec, Quebec, Kanada, G1V 4G5
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Placebo
|
placebo [NaCl]
|
|
Experimentell: Fentanyl
|
Single-dose of intrathecal fentanyl [25ug] Duration of fentanyl : 3.5 hours
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Endurance time
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Ventilatory response
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: François Maltais, MD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Lungsjukdomar
- Lungsjukdomar, obstruktiv
- Lungsjukdom, kronisk obstruktiv
- Läkemedels fysiologiska effekter
- Depressiva medel i centrala nervsystemet
- Agenter från det perifera nervsystemet
- Analgetika
- Sensoriska systemagenter
- Bedövningsmedel, intravenöst
- Anestesimedel, general
- Bedövningsmedel
- Analgetika, Opioid
- Narkotika
- Adjuvans, anestesi
- Fentanyl
Andra studie-ID-nummer
- SPINAL-20520
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .