Analysing Peripheral Skeletal Muscle Function Before and After Endobronchial Valve Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Emphysema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EBV-patients

Patients who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves.

31P-Magnetic Resonance Spectroscopy (31P-MRS)

Intervention Type DIAGNOSTIC_TEST

31P-Magnetic Resonance Spectroscopy will be performed during exercise testing.

Interventions

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31P-Magnetic Resonance Spectroscopy (31P-MRS)

31P-Magnetic Resonance Spectroscopy will be performed during exercise testing.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Muscle biopsy

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No