Analysing Peripheral Skeletal Muscle Function Before and After Endobronchial Valve Treatment (ENDURANCE)
Analysing cEllular Bioenergetics aNd Structural aDaptations in the qUadriceps Muscle befoRe and After endobroNChial Valve treatmEnt
Rationale: Chronic obstructive pulmonary disease (COPD) is characterised by a high prevalence of peripheral muscle dysfunction, which can have significant clinical consequences, including decreased exercise capacity, reduced quality of life, and even a higher mortality rate. Reduction of lung hyperinflation using bronchoscopic lung volume reduction treatment with one-way endobronchial valves (EBV) is a minimally invasive intervention which improves exercise capacity and physical activity in patients with severe emphysema. This positive effect is also related to weight gain and alterations in body composition. The physiologic and structural adaptations of skeletal muscle function after EBV treatment has never been investigated before.
Objective: To investigate the physiological and structural adaptations of peripheral muscle function at a cellular level in response to EBV treatment.
Study design: A single center, prospective clinical trial with a single-arm pretest-posttest design. Patients with severe emphysema who will receive a bronchoscopic lung volume reduction treatment are asked to undergo additional in-magnet exercise testing and muscle biopsies before and after placement of EBVs.
Study population: Patients with severe emphysema who are scheduled to undergo EBV treatment.
Main study parameters/endpoints: The difference in quadriceps phosphocreatine concentration (PCr), quadriceps inorganic phosphorus concentration (Pi), and quadriceps pH at rest, during progressive exercise, and recovery rate will be measured by 31P-MRS to assess the physiological effect of EBV treatment on skeletal muscle function and its bioenergetics. Furthermore, we will perform a detailed histological and biochemical analysis of muscle fiber type composition, mitochondrial density, master regulators of muscle oxidative programming, and mitochondrial respiration before and after EBV treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jorine Hartman, PhD
- Phone Number: +31503619194
- Email: j.hartman@umcg.nl
Study Contact Backup
- Name: Else ter Haar, MD
- Phone Number: +31503619194
- Email: e.a.m.d.ter.haar@umcg.nl
Study Locations
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Groningen, Netherlands
- Recruiting
- Univeristy Medical Center Groningen
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Contact:
- Else ter Haar, MD
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Contact:
- Jorine Hartman, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient is scheduled for a bronchoscopic lung volume treatment using one-way endobronchial valves;
- Patient read, understood and signed the Informed Consent Form.
Exclusion Criteria:
- Inability to perform a cycle ergometry test;
- Contraindications for undergoing a magnetic resonance imaging scan (e.g. claustrophobia, implanted cardiac devices);
- Body length >190cm;
- Any anticoagulant therapy;
- COPD exacerbation 4 weeks prior to testing.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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EBV-patients
Patients who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves.
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31P-Magnetic Resonance Spectroscopy will be performed during exercise testing.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in quadriceps phosphocreatine concentration measured by 31P-MRS.
Time Frame: 6 months
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To assess the physiological adaptations, in terms of cellular bioenergetics, of the quadriceps muscle in patients with severe COPD in response to EBV treatment.
This will be done by performing 31P-MRS during exercise testing in a MR-compatible ergometer at baseline and at 6 months follow-up, for which the quadriceps phosphocreatine concentration (PCr) at rest and during progressive exercise will be assessed.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in muscle fiber type composition measured in muscle biopsies.
Time Frame: 6 months
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Change in muscle fiber type composition 6 months after EBV treatment measured in muscle biopsies.
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6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Dirk-Jan Slebos, MD PhD, UMC Groningen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENDURANCE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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