Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06025500

Analysing Peripheral Skeletal Muscle Function Before and After Endobronchial Valve Treatment

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

15

Start Date

2024-10-01

Completion Date

2025-12-01

Last Updated

2024-11-25

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

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

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

Locations (1)

Univeristy Medical Center Groningen

Groningen, Netherlands