NCT06025500 Analysing Peripheral Skeletal Muscle Function Before and After Endobronchial Valve Treatment
| NCT ID | NCT06025500 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Emphysema |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2024-10-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Dirk-Jan Slebos, MD PhD
PRINCIPAL INVESTIGATOR
UMC Groningen
Frequently Asked Questions
Who can join the NCT06025500 clinical trial?
This trial is open to participants of all sexes, studying Emphysema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06025500 currently recruiting?
Yes, NCT06025500 is actively recruiting participants. Contact the research team at e.a.m.d.ter.haar@umcg.nl for enrollment information.
Where is the NCT06025500 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT06025500 clinical trial?
NCT06025500 is sponsored by University Medical Center Groningen. The principal investigator is Dirk-Jan Slebos, MD PhD at UMC Groningen. The trial plans to enroll 15 participants.