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Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With BPCO and Research for Predictive Factors of Fall Risk. (Equil-BPCO)

2019年8月12日 更新者:University Hospital, Clermont-Ferrand

Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With Chronic Obstructive Pulmonary Disease and Research for Predictive Factors of Fall Risk.

The risk of falling in increased in patients with Chronic Obstructive Pulmonary Disease. To date, a screening test (the Berg Balance scale, BBS) is used to evaluate this risk but it spends 20 to 30 minutes to complete.

The aim of our study is to evaluate the sensitivity of a more straightforward test (Timed Up and Go, TUG)) to assess the fall risk. The TUG is routinely used in elderly to screen for frailty.

研究概览

地位

完全的

详细说明

We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy.

The patients will be proposed to perform the following tests and to fill in questionnaires:

- Questionnaires: Elderly Falls Screening Test to quantify the falls in the last year, Hospital Anxiety and Depression Scale, Activities-specific Balance Confidence scale.

Tests:

  • Berg Balance Scale measuring balance in 14 different functional tasks (abnormal cut-off value <56)
  • Timed Up and Go evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).
  • 6 minute walk test evaluating endurance to submaximal exercise.
  • Isokinetic maximal force of the quadriceps at 60°/s
  • Balance control: posturography consisting in measuring variations when standing on a force platform.
  • Body composition assessment through Dual Xray Absorptiometry (DXA), to measure body muscle mass and more specifically appendicular muscle mass index as a criteria of sarcopenia, and bone mineral density.
  • Blood analysis: a blood sample will be withdrawn to measure calcium, phosphorus, vitamin D, albumin transthyretin, cell count, C reactive protein.

Analysis of the results:

We will calculate the sensitivity of the TUG test (abnormal test) to detect fall risk as assessed by an abnormal BBS score.

Moreover, in fallers, we will search for predictive factors. More specifically, we will look for the role of a decreased quadriceps force, a reduced muscle mass, a poor tolerance of exercise, the presence of hypoxia (severity of the disease).

Perspectives:

When validated as a screening test for the risk of falling in COPD patients, the TUG test could be used routinely by physiotherapists as a more simple and faster test and will enable to prevent falls through initiation of a balance control training program.

研究类型

观察性的

注册 (实际的)

50

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

    • Auvergne
      • Clermont-Ferrand、Auvergne、法国、63003
        • CHU de Clermont-Ferrand

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

有资格学习的性别

全部

取样方法

非概率样本

研究人群

We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy.

描述

Inclusion Criteria:

  • COPD confirmed by pulmonary function tests
  • Long term oxygen therapy since at least 3 months in the LOT+ subgroup

Exclusion Criteria:

  • Exacerbation of COPD necessitating an hospitalization or an oral corticosteroid treatment, in the last 4 weeks
  • Pulmonary rehabilitation in the last 3 months
  • Any neurological disease affecting balance control.
  • Inability to perform a walk test

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 without chronic respiratory failure

We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy.

The patients will be proposed to perform the following tests and to fill in questionnaires

It's a functional test evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).
COPD patients with home oxygen therapy

We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy.

The patients will be proposed to perform the following tests and to fill in questionnaires

It's a functional test evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).

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
Comparison of the Timed Up and Go test and the Berg Balance scale
大体时间:at day 1
Comparison of the consistency of abnormal value of the Timed Up and Go test and the Berg Balance scale
at day 1

次要结果测量

结果测量
措施说明
大体时间
Sensitivity of the TUG test and the BBS
大体时间:at day 1
to detect fall as assessed by the Elderly Falls Screening Test.
at day 1
Difference in BBS score
大体时间:at day 1
between COPD patients without and with chronic respiratory failure (LOT+/- subgroups).
at day 1
Identify predictive factors of fall risk
大体时间:at day 1
walk distance, quadriceps force, muscle mass, balance control.
at day 1

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。

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)

2017年1月2日

初级完成 (实际的)

2017年10月27日

研究完成 (实际的)

2017年10月27日

研究注册日期

首次提交

2017年5月11日

首先提交符合 QC 标准的

2017年5月11日

首次发布 (实际的)

2017年5月15日

研究记录更新

最后更新发布 (实际的)

2019年8月13日

上次提交的符合 QC 标准的更新

2019年8月12日

最后验证

2019年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • CHU-332
  • 2016-A01188-43 (其他标识符:2016-A01188-43)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

COPD Diagnosed的临床试验

Timed Up and Go的临床试验

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