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

NCT ID: NCT01522729

Last Updated: 2012-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-01-31

Brief Summary

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.

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: QUADRUPLE

Study Groups

Fentanyl

Group Type: EXPERIMENTAL

Fentanyl

Intervention Type: DRUG

Single-dose of intrathecal fentanyl \[25ug\] Duration of fentanyl : 3.5 hours

Placebo

Group Type: EXPERIMENTAL

Placebo comparator

Intervention Type: DRUG

placebo \[NaCl\]

Interventions

Fentanyl

Single-dose of intrathecal fentanyl \[25ug\] Duration of fentanyl : 3.5 hours

Intervention Type: DRUG

Placebo comparator

placebo \[NaCl\]

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Philippe Gagnon, PhD Candidate

PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

François Maltais, MD

Role: PRINCIPAL_INVESTIGATOR

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Locations

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, Quebec, Canada

Countries

Canada

References

Gagnon P, Bussieres JS, Ribeiro F, Gagnon SL, Saey D, Gagne N, Provencher S, Maltais F. Influences of spinal anesthesia on exercise tolerance in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2012 Oct 1;186(7):606-15. doi: 10.1164/rccm.201203-0404OC. Epub 2012 Jul 19.

Reference Type: DERIVED

PMID: 22822019 (View on PubMed)

Other Identifiers

SPINAL-20520

Identifier Type: -

Identifier Source: org_study_id