Examining muscle function changes before and after endobronchial valve treatment for emphysema

Analysing cEllular Bioenergetics aNd Structural aDaptations in the qUadriceps Muscle befoRe and After endobroNChial Valve treatmEnt

This study is testing how a specific lung treatment for severe emphysema affects muscle function in patients to see if it helps them feel better and move more easily.

Quick facts

• Study type: Observational
• Enrollment: 15 (estimated)
• Sex: All
• Sponsor: University Medical Center Groningen (Academic / other)
• Locations: 1 site (Groningen)
• Trial ID: NCT06025500 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the physiological and structural adaptations of peripheral muscle function at a cellular level in patients with severe emphysema who are scheduled for bronchoscopic lung volume reduction treatment using one-way endobronchial valves. The study employs a single-arm pretest-posttest design, utilizing 31P-Magnetic Resonance Spectroscopy to assess muscle function before and after the intervention. By understanding these adaptations, the study seeks to provide insights into the broader impacts of EBV treatment on exercise capacity and quality of life for patients with chronic obstructive pulmonary disease (COPD).

Who should consider this trial

Good fit: Ideal candidates are patients scheduled for bronchoscopic lung volume treatment using one-way endobronchial valves.

Not a fit: Patients who cannot perform a cycle ergometry test or have contraindications for MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of how endobronchial valve treatment improves muscle function and overall quality of life in emphysema patients.

How similar studies have performed: While the specific physiological adaptations of skeletal muscle function post-EBV treatment have not been previously investigated, related studies on lung volume reduction treatments have shown promising outcomes.

Eligibility criteria

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.

Where this trial is running

Groningen

• Univeristy Medical Center Groningen — Groningen, Netherlands (Recruiting)

Study contacts

• Principal investigator: Dirk-Jan Slebos, MD PhD — UMC Groningen
• Study coordinator: Else ter Haar, MD

Conditions Emphysema