An observational study in Emphysema, sponsored by University Medical Center Groningen. Recruiting at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by University Medical Center Groningen · Observational
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.
382 studies on the registry are indexed under Emphysema; 59 are open to participants now.
This study's planned enrollment of 15 is below the median of 131 across 111 observational studies indexed under Emphysema.
Browse Emphysema studies →University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 176 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves.
Diagnostic Test: 31P-Magnetic Resonance Spectroscopy (31P-MRS)
31P-Magnetic Resonance Spectroscopy will be performed during exercise testing.
Also known as: Muscle biopsy
Change in quadriceps phosphocreatine concentration measured by 31P-MRS.
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.
Time frame: 6 months
Change in muscle fiber type composition measured in muscle biopsies.
Change in muscle fiber type composition 6 months after EBV treatment measured in muscle biopsies.
Time frame: 6 months
Plan to share: Undecided — Data can be shared on reasonable request
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Dec 2026, 26 months after the start.
Of 45 observational studies under Emphysema, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 35. This study's planned 26 months is below that.
How these figures are worked out, and which studies are left out of them.
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