- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
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Quebec
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Québec, Quebec, Kanada, G1V 4G5
- Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Placebo
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placebo [NaCl]
|
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Experimental: Fentanyl
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Single-dose of intrathecal fentanyl [25ug] Duration of fentanyl : 3.5 hours
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Endurance time
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Ventilatory response
Zeitfenster: 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)
|
|
Quadriceps muscle fatigue
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: François Maltais, MD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen der Atemwege
- Lungenkrankheit
- Lungenerkrankungen, obstruktive
- Lungenerkrankung, chronisch obstruktiv
- Physiologische Wirkungen von Arzneimitteln
- Depressiva des zentralen Nervensystems
- Agenten des peripheren Nervensystems
- Analgetika
- Agenten des sensorischen Systems
- Anästhetika, intravenös
- Anästhesie, Allgemein
- Anästhetika
- Analgetika, Opioide
- Betäubungsmittel
- Adjuvantien, Anästhesie
- Fentanyl
Andere Studien-ID-Nummern
- SPINAL-20520
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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