Back to resultsMuscle Metabolism and Oxygenation During Localized Fatigue-exercise in COPD
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fatiguing exercise
Sponsored by
About this trial
This is an interventional basic science trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, Muscle fatigue, Energy metabolism, Muscle oxygenation
Eligibility Criteria
Inclusion Criteria:
- COPD (FEV1/FVC < 0.70 and FEV1 < 0.80 predicted
- Healthy subjects: no evidence of airways obstruction (FEV1/FVC > 0.70 and FEV1 > 0.80 predicted)
- Smoking history > 15 pack-years
Exclusion Criteria:
- Chronic hypoxemia and/or hypercapnia (PaO2 < 60 mmHg or SpO2 < 88% at rest and/or PaCO2 > 45 mmHg)
- Recent exacerbation (< 3 months)
- Recent cancer (< 3 years)
- Diabetes
- Myopathy, neuromuscular or articular disease
- Unstable cardiac disease
- Absolute contraindications to exercise testing
- Regular physical activity or exercise training program in the last 2 months
- Physical activity score > 9 in the Voorips questionnaire
- Thigh skinfold thickness > 15 mm
- BMI > 30
Sites / Locations
- Institut universitaire de cardiologie et de pneumologie de QuébecRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Oxygen
Room air
Arm Description
Outcomes
Primary Outcome Measures
Muscle deoxygenation
Changes of deoxyhemoglobin/myoglobin concentrations measured by near-infrared spectroscopy of vastus lateralis muscle.
Muscle metabolism
Changes in glycolytic and oxidative metabolism pathway markers, energy substrates (glycogen and glucose), end-products of glycolysis (pyruvate, and lactate), intermediate markers of glycolysis and high-energy phosphate compounds obtained from muscle biopsies
Secondary Outcome Measures
Ventilatory response
Minute ventilation will be monitored during the fatigue-inducing exercise and it will be compared between subjects and conditions (FiO2 = 21% vs. FiO2 = 100%)
Quadriceps muscle fatigue
Quadriceps muscle fatigue will be determined by loss of quadriceps strength measured by magnetic stimulation after the fatigue-inducing exercise.
Surface electromyography will also be measured to characterize muscle fatigue.
total muscle work
Total muscle work performed during fatigue-inducing exercise that will be composed by subsequent isokinetic knee-extensions repetitions at 40% of maximal peak torque
Full Information
NCT ID
NCT01909544
First Posted
July 16, 2013
Last Updated
February 6, 2014
Sponsor
Laval University
Collaborators
Canadian Lung Association
1. Study Identification
Unique Protocol Identification Number
NCT01909544
Brief Title
Muscle Metabolism and Oxygenation During Localized Fatigue-exercise in COPD
Official Title
Muscle Oxygenation and Metabolism in Response to a Localized Fatigue-inducing Exercise in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Canadian Lung Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate whether a localized exercise, in which cardiorespiratory demand is reduced, will result in greater limb muscle fatigue in patients with COPD as a consequence of muscle oxygenation and muscle metabolism disturbances.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Pulmonary Disease, Chronic Obstructive, Muscle fatigue, Energy metabolism, Muscle oxygenation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oxygen
Arm Type
Experimental
Arm Title
Room air
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Fatiguing exercise
Intervention Description
All participants (patients and healthy subjects) will perform the exercise both under normoxic (FiO2 = 0.21) and hyperoxic conditions (FiO2 = 100%)
Primary Outcome Measure Information:
Title
Muscle deoxygenation
Description
Changes of deoxyhemoglobin/myoglobin concentrations measured by near-infrared spectroscopy of vastus lateralis muscle.
Time Frame
45 seconds post-exercise (knee-extension repetitions)
Title
Muscle metabolism
Description
Changes in glycolytic and oxidative metabolism pathway markers, energy substrates (glycogen and glucose), end-products of glycolysis (pyruvate, and lactate), intermediate markers of glycolysis and high-energy phosphate compounds obtained from muscle biopsies
Time Frame
45 seconds post-exercise (knee extension repetitions)
Secondary Outcome Measure Information:
Title
Ventilatory response
Description
Minute ventilation will be monitored during the fatigue-inducing exercise and it will be compared between subjects and conditions (FiO2 = 21% vs. FiO2 = 100%)
Time Frame
Baseline, beginning and end of each serie of knee extensions (fatiguing exercise)
Title
Quadriceps muscle fatigue
Description
Quadriceps muscle fatigue will be determined by loss of quadriceps strength measured by magnetic stimulation after the fatigue-inducing exercise.
Surface electromyography will also be measured to characterize muscle fatigue.
Time Frame
baseline, 15 min and 40 min after the fatigue-inducing exercise
Title
total muscle work
Description
Total muscle work performed during fatigue-inducing exercise that will be composed by subsequent isokinetic knee-extensions repetitions at 40% of maximal peak torque
Time Frame
end of fatiguing exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
COPD (FEV1/FVC < 0.70 and FEV1 < 0.80 predicted
Healthy subjects: no evidence of airways obstruction (FEV1/FVC > 0.70 and FEV1 > 0.80 predicted)
Smoking history > 15 pack-years
Exclusion Criteria:
Chronic hypoxemia and/or hypercapnia (PaO2 < 60 mmHg or SpO2 < 88% at rest and/or PaCO2 > 45 mmHg)
Recent exacerbation (< 3 months)
Recent cancer (< 3 years)
Diabetes
Myopathy, neuromuscular or articular disease
Unstable cardiac disease
Absolute contraindications to exercise testing
Regular physical activity or exercise training program in the last 2 months
Physical activity score > 9 in the Voorips questionnaire
Thigh skinfold thickness > 15 mm
BMI > 30
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernanda Ribeiro, PhD candidate
Phone
418-656-8711
Ext
3928
Email
fernanda.ribeiro@criucpq.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Maltais, MD
Organizational Affiliation
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Maltais, MD
First Name & Middle Initial & Last Name & Degree
Didier Saey, PhD
First Name & Middle Initial & Last Name & Degree
Fernanda Ribeiro, PhD candidate
12. IPD Sharing Statement
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Muscle Metabolism and Oxygenation During Localized Fatigue-exercise in COPD
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