Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06025500
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2023-08-04
Brief Title:
Analysing Peripheral Skeletal Muscle Function Before and After Endobronchial Valve Treatment
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Analysing cEllular Bioenergetics aNd Structural aDaptations in the qUadriceps Muscle befoRe and After endobroNChial Valve treatmEnt
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENDURANCE
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 parametersendpoints 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
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 parametersendpoints 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None