Analysing cEllular Bioenergetics aNd Structural aDaptations in the qUadriceps Muscle befoRe and After endobroNChial Valve treatmEnt
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in quadriceps phosphocreatine concentration measured by 31P-MRS.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is scheduled for a bronchoscopic lung volume treatment using one-way endobronchial valves;
- •Patient read, understood and signed the Informed Consent Form.
排除标准
- •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.
研究组 & 干预措施
EBV-patients
Patients who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves.
干预措施: 31P-Magnetic Resonance Spectroscopy (31P-MRS) (Diagnostic Test)
结局指标
主要结局
Change in quadriceps phosphocreatine concentration measured by 31P-MRS.
时间窗: 6 months
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.
次要结局
- Change in muscle fiber type composition measured in muscle biopsies.(6 months)
研究者
Dirk-Jan Slebos
Head of the department of Pulmonary Diseases and Pulmonologist
University Medical Center Groningen