- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01909544
Muscle Metabolism and Oxygenation During Localized Fatigue-exercise in COPD
February 6, 2014 updated by: Fernanda Ribeiro, Laval University
Muscle Oxygenation and Metabolism in Response to a Localized Fatigue-inducing Exercise in Patients With Chronic Obstructive Pulmonary Disease
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fernanda Ribeiro, PhD candidate
- Phone Number: 3928 418-656-8711
- Email: fernanda.ribeiro@criucpq.ulaval.ca
Study Locations
-
-
Quebec
-
Québec, Quebec, Canada, G1V 4G5
- Recruiting
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec
-
Principal Investigator:
- François Maltais, MD
-
Sub-Investigator:
- Didier Saey, PhD
-
Sub-Investigator:
- Fernanda Ribeiro, PhD candidate
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oxygen
|
All participants (patients and healthy subjects) will perform the exercise both under normoxic (FiO2 = 0.21) and hyperoxic conditions (FiO2 = 100%)
|
Sham Comparator: Room air
|
All participants (patients and healthy subjects) will perform the exercise both under normoxic (FiO2 = 0.21) and hyperoxic conditions (FiO2 = 100%)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle deoxygenation
Time Frame: 45 seconds post-exercise (knee-extension repetitions)
|
Changes of deoxyhemoglobin/myoglobin concentrations measured by near-infrared spectroscopy of vastus lateralis muscle.
|
45 seconds post-exercise (knee-extension repetitions)
|
Muscle metabolism
Time Frame: 45 seconds post-exercise (knee extension repetitions)
|
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
|
45 seconds post-exercise (knee extension repetitions)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ventilatory response
Time Frame: Baseline, beginning and end of each serie of knee extensions (fatiguing exercise)
|
Minute ventilation will be monitored during the fatigue-inducing exercise and it will be compared between subjects and conditions (FiO2 = 21% vs. FiO2 = 100%)
|
Baseline, beginning and end of each serie of knee extensions (fatiguing exercise)
|
Quadriceps muscle fatigue
Time Frame: baseline, 15 min and 40 min after the fatigue-inducing exercise
|
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. |
baseline, 15 min and 40 min after the fatigue-inducing exercise
|
total muscle work
Time Frame: end of fatiguing exercise
|
Total muscle work performed during fatigue-inducing exercise that will be composed by subsequent isokinetic knee-extensions repetitions at 40% of maximal peak torque
|
end of fatiguing exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: François Maltais, MD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Anticipated)
July 1, 2014
Study Registration Dates
First Submitted
July 16, 2013
First Submitted That Met QC Criteria
July 23, 2013
First Posted (Estimate)
July 26, 2013
Study Record Updates
Last Update Posted (Estimate)
February 7, 2014
Last Update Submitted That Met QC Criteria
February 6, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MX-20665
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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