此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

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

地位

未知

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

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

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅