Muscle Metabolism and Oxygenation During Localized Fatigue-exercise in COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Muscle Oxygenation and Metabolism in Response to a Localized Fatigue-inducing Exercise in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01909544
• Other study ID #: MX-20665
• Status: Recruiting
• Phase: N/A
• First received: July 16, 2013
• Last updated: February 6, 2014
• Start date: September 2011

Study information

• Verified date: February 2014
• Source: Laval University
• Contact: Fernanda Ribeiro, PhD candidate
• Phone: 418-656-8711
• Email: fernanda.ribeiro[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Fatiguing exercise
All participants (patients and healthy subjects) will perform the exercise both under normoxic (FiO2 = 0.21) and hyperoxic conditions (FiO2 = 100%)

Locations

Country	Name	City	State
Canada	Institut universitaire de cardiologie et de pneumologie de Québec	Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	Canadian Lung Association, Fondation J-D Bégin de l'Université Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle deoxygenation	Changes of deoxyhemoglobin/myoglobin concentrations measured by near-infrared spectroscopy of vastus lateralis muscle.	45 seconds post-exercise (knee-extension repetitions)	No
Primary	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	45 seconds post-exercise (knee extension repetitions)	No
Secondary	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%)	Baseline, beginning and end of each serie of knee extensions (fatiguing exercise)	No
Secondary	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.	baseline, 15 min and 40 min after the fatigue-inducing exercise	No
Secondary	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	end of fatiguing exercise	No