Muscle Function After Lung Transplantation in Patients With Chronic Obstructive Pulmonary Disease (COPD) (COPD)
2019年12月24日 更新者:Camilla Koch Ryrsø、Rigshospitalet, Denmark
The purpose of the project is to investigate changes in the quadriceps muscle and cardiovascular regulation during exercise in relation to improved lung function after lung transplantation in patients with COPD.
研究概览
详细说明
Dysfunctional skeletal musculature of the lower limbs is related to low quality of life, exercise intolerance and higher mortality in patients with COPD.
Limb muscle dysfunction in COPD consists of muscle atrophy and reduced muscle strength but also intra-muscular alterations in oxidative capacity and mitochondrial function are often present.
Moreover, reduced blood flow to exercising muscle may also contribute to the muscle dysfunction in COPD.
The mechanisms responsible for muscle dysfunction in COPD patients remain unclear but could be a consequence of reduced lung function, inflammation, medications or low physical activity.
Loss of lung function with COPD is normally irreversible so the transition to near-normal lung function after lung transplantation is a unique model to investigate the adaptation of the limb muscle to improved lung function.
Thus, the purpose of this project is to investigate the effect of lung transplantation on limb muscle function (mitochondrial function, oxidative enzyme capacity, fiber type distribution, oxygen delivery/uptake) and daily physical activity level in patients with COPD.
The project has a translational focus on muscle dysfunction in COPD and uses methodologies from clinical medicine, integrative physiology and molecular biochemistry in order to gain knowledge of mechanisms behind limb muscle dysfunction and exercise intolerance in COPD.
研究类型
观察性的
注册 (预期的)
20
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Copenhagen、丹麦
- 招聘中
- the Centre for Physical Activity Research, Copenhagen University Hospital
-
接触:
- Ulrik Winning Iepsen, MD, PhD
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
COPD patients on the waiting list for a lung transplantation
描述
Inclusion Criteria:
- COPD with or without alpha 1-antitrypsin deficiency on the waiting list for a lung transplantation
- Single or double lung transplantation
- ≥ 18 years
- Ability to give informed consent
Exclusion Criteria:
- Retransplantation
- Multiple-organ transplantation (heart-lung transplantation)
- Musculoskeletal disorders which substantially inhibits physical activity
- Need for crossmatching in connection with lung transplantation
- Anticoagulant therapy before lung transplantation (except acetylsalicylic acid)
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
COPD patients
COPD patients on the waiting list for a lung transplantation
|
Single or double lung transplantation in patients with COPD
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in leg blood flow (mL/min)
大体时间:Change from baseline at 6 months
|
Endothelium function will be evaluated during acute exercise (one legged kicking) by Flow doppler
|
Change from baseline at 6 months
|
|
Change in 6 min walking test
大体时间:Change from baseline at 6 months
|
Exercise capacity
|
Change from baseline at 6 months
|
|
Change in health-related quality of life
大体时间:Change from baseline at 6 months
|
Health-related quality of life will be assessed by total mean score of St. George's Respiratory Questionnaire (SGRQ) (2 parts,3 components questionnaire).
Scores range from 0 to 100, with higher scores indicating more limitations.
A minimum change in score of 4 units are considered clinically relevant.
|
Change from baseline at 6 months
|
|
Change in health-related quality of life
大体时间:Change from baseline at 6 months
|
Health-related quality of life will be assessed by mean score of a validated Danish version of the COPD Assessment Test (CAT).
The CAT is a short 8-item questionnaire with scoring range of 0-40, where higher scores indicating more limitations.
A change of 2 units suggests a meaningful difference.
|
Change from baseline at 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in skeletal muscle function
大体时间:Change from baseline at 6 months
|
Muscle biopsy
|
Change from baseline at 6 months
|
|
Change in blood volume
大体时间:Change from baseline at 6 months
|
CO re-breathing method
|
Change from baseline at 6 months
|
|
Change in capillarization of lung tissue
大体时间:Change from baseline at 6 months
|
Transbronchial biopsy (only COPD patients)
|
Change from baseline at 6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Ulrik Winning Iepsen, MD, PhD、Centre for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年8月20日
初级完成 (预期的)
2020年4月30日
研究完成 (预期的)
2020年5月30日
研究注册日期
首次提交
2018年5月9日
首先提交符合 QC 标准的
2018年5月24日
首次发布 (实际的)
2018年6月7日
研究记录更新
最后更新发布 (实际的)
2019年12月26日
上次提交的符合 QC 标准的更新
2019年12月24日
最后验证
2019年12月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- H-17039327
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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