NCT01522729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
Last Updated

February 1, 2012

Status Verified

January 1, 2012

Enrollment Period

1.3 years

First QC Date

January 20, 2012

Last Update Submit

January 27, 2012

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic pulmonary obstructive diseaseMuscle dysfunctionExercise intoleranceMuscle afferentsVentilation

Outcome Measures

Primary Outcomes (1)

  • Endurance time

    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)

Secondary Outcomes (4)

  • Ventilatory response

    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

    15-min after the end of constant-workload cycling test

  • Dynamic hyperinflation

    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

    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

Study Arms (2)

Fentanyl

EXPERIMENTAL
Drug: Fentanyl

Placebo

EXPERIMENTAL
Drug: Placebo comparator

Interventions

FentanylDRUG

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

Fentanyl
Placebo comparatorDRUG

placebo \[NaCl\]

Placebo

Eligibility Criteria

Age55 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoking history \> 15 pack-years
  • COPD GOLD II-III (30 % predicted \< FEV1 \< 80 % predicted; FEV1/FVC \< 0.70)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 22822019DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Aspiration

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • François Maltais, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

January 20, 2012

First Posted

February 1, 2012

Study Start

October 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 1, 2012

Record last verified: 2012-01

Locations

CA(1)