Muscle Metabolism and Oxygenation During Localized Fatigue-exercise in COPD

NCT01909544 | Unknown

• 1 other identifier: MX-20665
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive; Muscle fatigue; Energy metabolism; Muscle oxygenation

Outcome Measures

Primary Outcomes (2)

• Muscle deoxygenation

  Changes of deoxyhemoglobin/myoglobin concentrations measured by near-infrared spectroscopy of vastus lateralis muscle.

  45 seconds post-exercise (knee-extension repetitions)

• 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)

Secondary Outcomes (3)

• Ventilatory response

  Baseline, beginning and end of each serie of knee extensions (fatiguing exercise)

• Quadriceps muscle fatigue

  baseline, 15 min and 40 min after the fatigue-inducing exercise

• total muscle work

  end of fatiguing exercise

Study Arms (2)

Oxygen

EXPERIMENTAL

Other: Fatiguing exercise

Room air

SHAM COMPARATOR

Other: Fatiguing exercise

Interventions

Fatiguing exercise OTHER

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

Oxygen; Room air

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Canadian Lung Association: collaborator

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• François Maltais, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda Ribeiro, PhD candidate

CONTACT

418-656-8711; fernanda.ribeiro@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 26, 2013
• Study Start: September 1, 2011
• Primary Completion: July 1, 2014
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

CA (1)