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Impact of Muscle Afferent Feedback During Exercise in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philippe Gagnon, PhD Candidate, Laval University
ClinicalTrials.gov Identifier:
NCT01522729
First received: January 20, 2012
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Drug: Fentanyl
Drug: Placebo comparator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Impact of Somatosensory Feedback on Peripheral Muscle Fatigue and Exercise Tolerance in Patients With COPD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:
  • Endurance time [ Time Frame: 60-min post-anesthesia - From the start to the end of the constant-workload cycling test (limited by symptoms of the patients) ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Ventilatory response [ Time Frame: 60-min post-anesthesia-From the start to the end of the constant-workload cycling test (limited by symptoms of the patients) ] [ Designated as safety issue: No ]
    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)

  • Quadriceps muscle fatigue [ Time Frame: 15-min after the end of constant-workload cycling test ] [ Designated as safety issue: No ]
    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.

  • Dynamic hyperinflation [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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)

  • Effort perception [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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)


Enrollment: 8
Study Start Date: October 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fentanyl Drug: Fentanyl
Single-dose of intrathecal fentanyl [25ug] Duration of fentanyl : 3.5 hours
Experimental: Placebo Drug: Placebo comparator
placebo [NaCl]

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522729

Locations
Canada, Quebec
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: François Maltais, MD Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
  More Information

No publications provided

Responsible Party: Philippe Gagnon, PhD Candidate, PhD Candidate, Laval University
ClinicalTrials.gov Identifier: NCT01522729     History of Changes
Other Study ID Numbers: SPINAL-20520
Study First Received: January 20, 2012
Last Updated: January 27, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Laval University:
Chronic pulmonary obstructive disease
Muscle dysfunction
Exercise intolerance
Muscle afferents
Ventilation

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 23, 2013