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Efficacy of Arm Training in COPD Patients (UEET-COPD)

2011年8月2日 更新者：Villa Pineta Hospital

Effects of Unsupported Upper Extremity Exercise Training in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial

Recent guidelines on pulmonary rehabilitation (PR) recommend upper extremity exercise training (UEET) in patients with chronic obstructive pulmonary disease (COPD).

The theory supporting the inclusion of upper extremity exercise training in the pulmonary rehabilitation for these patients, is based on the profound understanding of the activity of the accessory respiratory muscles, which are competitively involved in both the support of the upper extremities during activities and the ventilation. However, a systematic review of the literature carried out by our staff reveals that the clinical trials carried out up to now to verify the effectiveness of UEET are of poor methodological quality and the investigators cannot corroborate the recommendation recently made on the basis of the results of the investigators' review.

Therefore the investigators began this randomized, parallel groups, controlled clinical trial with the purpose of determining the short-term effect of unsupported UEET on the performance of the upper extremities and on symptoms perceived during activities by patients with COPD.

研究概览

地位

完全的

条件

干预/治疗

详细说明

We recruited inpatients with stable, moderate or severe COPD referred to the PR program at the regional centre of Villa Pineta Hospital.

Patients were randomized into two groups: control and intervention. Patients randomized to the control group undertook an inpatient comprehensive PR that complied with the recommendations made by the ATS/ERS and included a minimum of 15 daily sessions of specific training for lower extremities.

Patients randomized to the intervention group undertook an experimental program consisting of 15 additional daily sessions of unsupported UEET over and above the same PR program used for control patients.

Measurements of upper extremity performance and symptoms perceived were taken in both groups at baseline (T0) and at the completion of the interventions (Tend) by one physiotherapist unaware to the patient's group allocation. To verify if the experimental training leads to long-term results on the functional arm exercise capacity, some measurements were repeated at 6-months as the latest follow-up (T6months).

研究类型

介入性

注册 (实际的)

50

阶段

  • 不适用

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

  • 意大利
    • Modena
      • Pavullo nel Frignano、Modena、意大利、41026
        • Villa Pineta Hospital

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • diagnosis of COPD
  • a degree of COPD severity equal or above grade 2 (moderate) on the basis of the GOLD classification
  • clinical stability for a minimum of 4 weeks
  • degree of chronic dyspnea ≥ grade 2 on the Medical Research Council Dyspnea Scale

Exclusion Criteria:

  • muscular-skeletal abnormalities limiting the shoulder girdle functionality
  • cognitive impairment limiting participation
  • previous inclusion in UEET programmes within the last 3 years
  • malignancies

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

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：1: comprehensive PR
Inpatient comprehensive PR program that lasted lasted 3 weeks and included a minimum of 15 daily sessions of specific training for lower extremities, education, nutritional intervention, psychosocial intervention. It complied with the recommendation of the ATS/ERS.
程序：comprehensive PR
Inpatient comprehensive PR program that lasted lasted 3 weeks and included a minimum of 15 daily sessions of specific training for lower extremities, education, nutritional intervention, psychosocial intervention. It complied with the recommendation of the ATS/ERS.
其他名称：
  • 肺康复
实验性的：2: UEET + PR
Experimental program consisting in additional 15 daily sessions of unsupported UEET over and above the same PR program used for control patients.
程序：UEET
Experimental program consisting of 15 additional daily sessions of unsupported UEET.
其他名称：
  • Upper extremity exercise training

研究衡量的是什么？

主要结果指标

结果测量
大体时间
6-min. ring test (6MRT)
大体时间：T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
T0=baseline, Tend (week three) , T6months (six months after the completion of the training)

次要结果测量

结果测量
大体时间
ADL field test
大体时间：T0=baseline, Tend (week three)
T0=baseline, Tend (week three)
LCADL
大体时间：T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
MRC
大体时间：T0=baseline, Tend (week three)
T0=baseline, Tend (week three)
6MWT
大体时间：T0=baseline, Tend (week three)
T0=baseline, Tend (week three)

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。

赞助

Villa Pineta Hospital

合作者

University of Modena and Reggio Emilia

调查人员

  • 首席研究员：Stefania Costi, Dr、University of Modena and Reggio Emilia
  • 学习椅：Enrico M Clini, Professor、Villa Pineta Hospital and University of Modena and Reggio Emilia

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2007年3月1日

初级完成 (实际的)

2007年10月1日

研究完成 (实际的)

2008年4月1日

研究注册日期

首次提交

2009年1月15日

首先提交符合 QC 标准的

2009年1月16日

首次发布 (估计)

2009年1月19日

研究记录更新

最后更新发布 (估计)

2011年8月4日

上次提交的符合 QC 标准的更新

2011年8月2日

最后验证

2009年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • UEET0307

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.

comprehensive PR的临床试验

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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