Analysis of Postural Control of COPD Patients (ATTRACTION) (ATTRACTION)
2022年1月14日 更新者：Graziella Brinchault、University of Rennes 2
Quantified Analysis of Postural Control of COPD Patients During Tasks of Daily Living
Chronic Obstructive Pulmonary Disease (COPD) is a common chronic respiratory disease, causing disabling respiratory symptoms and impairing patients' quality of life.
Currently one of the leading causes of death worldwide, COPD is a major socio-economic concern.
It is also accompanied by extremely frequent extra-respiratory manifestations (or co-morbidities).
Among these secondary manifestations, the equilibrium of these patients is subject to modifications: thus, numerous studies have shown that the equilibrium of COPD patients was altered compared to healthy age-matched subjects.
This alteration is associated with a greater functional limitation and a higher risk of falling.
Although this impairment has been demonstrated clinically, the balance of these patients has never been analysed using quantified movement analysis tools during tasks similar to those performed in daily life.
Moreover, the underlying mechanisms remain unknown and the possible associations with several clinical factors of interest (pain, dyspnea, muscle function...) have not yet been assessed.
The hypotheses of this project are that (1) the postural control of COPD patients is altered compared to healthy subjects during tasks of daily living and these changes can be characterised.
(2) Several clinical factors are associated with these changes.
研究概览
地位
尚未招聘
条件
研究类型
观察性的
注册 (预期的)
32
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。
学习联系方式
- 姓名：Romain Pichon, MSc
- 电话号码：0667774267
- 邮箱：r.pichon@ifpek.org
研究联系人备份
- 姓名：Armel Cretual, PhD
- 邮箱：armel.cretual@univ-rennes2.fr
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
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 that realize their medical follow-up at University Hospital of Rennes
描述
Inclusion Criteria:
- COPD patients GOLD stage 2 and 3 (A-D)
- In accordance with Article L1121-8-1 of the Public Health Code, participants must be affiliated to a social security scheme or benefit from such a scheme.
Exclusion Criteria:
- the presence of long-term or exercise-based oxygen therapy,
- the presence of a medically diagnosed pathology causing manifest disorders of balance,
- the inability to walk 150 m without stopping and to climb or descend stairs,
- a history of pneumonectomy or lobectomy within the last six months,
- the existence of an acute respiratory exacerbation within the last two months,
- the presence of obvious cognitive impairment that impairs comprehension of instructions,
- body mass index less than 21 or more than 35 kg/m².
Person referred to in articles L. 1121-5 to L. 1121-8 and L. 1121-12 of the public health code:
- Pregnant woman, woman in labour or nursing mother
- Person deprived of liberty by judicial or administrative decision
- Person hospitalised without consent and not subject to a legal protection measure, and person admitted to a health or social establishment for purposes other than research
- Minor
- Person subject to a period of exclusion for other research
- Person of full age subject to a legal protection measure (guardianship, curatorship or safeguard of justice), person of full age unable to express their consent and not subject to a protection measure
- Person under psychiatric care
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 |
|---|---|
|
健康控制
|
functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)
|
|
慢性阻塞性肺病患者
|
functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)
|
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 |
|---|---|---|
|
Margins of stability
大体时间：Clinical assessment at baseline
|
Postural control parameter related to the centre of mass (CoM) and the base of support of the participant, assessed during the functional tests
|
Clinical assessment at baseline
|
|
Margins of stability variability
大体时间：Clinical assessment at baseline
|
Coefficient of variation of a postural control parameter related to the centre of mass (CoM) and the base of support of the participant, assessed during the functional tests
|
Clinical assessment at baseline
|
|
Center of Mass velocity
大体时间：Clinical assessment at baseline
|
Parameter of participant's Centre of Mass (CoM) during the functional tests
|
Clinical assessment at baseline
|
|
Center of mass displacement
大体时间：Clinical assessment at baseline
|
Parameter of participant's Centre of Mass (CoM) during the functional tests
|
Clinical assessment at baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evolution of articular angulations
大体时间：Clinical assessment at baseline
|
Articular angulations assessed at the ankle, knee, hip, spine and thoracic level during the functional tests
|
Clinical assessment at baseline
|
|
Centre of pressure (CoP) Area
大体时间：Clinical assessment at baseline
|
Parameter of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test
|
Clinical assessment at baseline
|
|
Centre of pressure (CoP) velocity
大体时间：Clinical assessment at baseline
|
Parameter of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test
|
Clinical assessment at baseline
|
|
Centre of pressure (CoP) variability
大体时间：Clinical assessment at baseline
|
Coefficient of variation of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test
|
Clinical assessment at baseline
|
|
Gait Cadence
大体时间：Clinical assessment at baseline
|
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
|
Clinical assessment at baseline
|
|
Gait velocity
大体时间：Clinical assessment at baseline
|
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
|
Clinical assessment at baseline
|
|
Gait phases duration
大体时间：Clinical assessment at baseline
|
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
|
Clinical assessment at baseline
|
|
Step width
大体时间：Clinical assessment at baseline
|
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
|
Clinical assessment at baseline
|
|
Step length
大体时间：Clinical assessment at baseline
|
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
|
Clinical assessment at baseline
|
|
Completion time of the Modified Glittre ADL
大体时间：Clinical assessment at baseline
|
Time to complete the modified Glittre-ADL test
|
Clinical assessment at baseline
|
|
Completion time of the timed up and go test
大体时间：Clinical assessment at baseline
|
Time to complete the timed up and go test test
|
Clinical assessment at baseline
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Dyspnea assessment scale
大体时间：Clinical assessment at baseline
|
assessed by the modified Borg Scale which is a 0 to 10 scale (0 representing no dyspnea, 10 representing the worst imaginable dyspnea).
Dyspnea is assessed before, during and after the functional tests
|
Clinical assessment at baseline
|
|
Heart rate
大体时间：Clinical assessment at baseline
|
assessed before, during and after functional tests
|
Clinical assessment at baseline
|
|
Leg discomfort scale
大体时间：Clinical assessment at baseline
|
assessed on a 0 to 10 scale (0 representing no discomfort, 10 representing the worst imaginable discomfort).Leg discomfort is assessed before, during and after the functional tests
|
Clinical assessment at baseline
|
|
Visual analog scale for pain
大体时间：Clinical assessment at baseline
|
Pain is assessed by a visual analog scale which is a 100mm long horizontal line with verbal descriptors at each end to express the extremes of the feeling (Here no pain and the worst imaginable pain)
|
Clinical assessment at baseline
|
|
Pain Drawing scale
大体时间：Clinical assessment at baseline
|
participants are invited to identify on a body chart the location of experienced pain.
|
Clinical assessment at baseline
|
|
Multi-dimensional dyspnea profile (MDP)
大体时间：Clinical assessment at baseline
|
Dyspnea assessment tool which investigates sensory and affective dimensions of dyspnea
|
Clinical assessment at baseline
|
|
London chest activity of daily living questionnaire (LCADL)
大体时间：Clinical assessment at baseline
|
Dyspnea assessment tool which investigates the impact of dyspnea on 15 activities of daily living.
A score from 0 to 5 is given for each activity, 5 representing an higher impact of dyspnea on the activity.
|
Clinical assessment at baseline
|
|
Modified Medical Research Council Scale (MMRC)
大体时间：Clinical assessment at baseline
|
Dyspnea assessment tool which investigates impact of dyspnea in participants life.
This is a 0 to 4 scale with descriptors associated to each number.
4 representing the most severe impact of dyspnea.
|
Clinical assessment at baseline
|
|
Charlson Index
大体时间：Clinical assessment at baseline
|
Comorbidities assessment tool which list 19 potential comorbidities associated with a weighted score.
The points are attributed when the comorbidity is present.
A total score is then calculated.
An higher score indicates an higher severity.
|
Clinical assessment at baseline
|
|
Body composition
大体时间：Clinical assessment at baseline
|
Determination of fat free mass and fat mass by bioelectrical impedance analysis.
|
Clinical assessment at baseline
|
|
Maximal inspiratory pressure
大体时间：Clinical assessment at baseline
|
inspiratory muscles strength assessment
|
Clinical assessment at baseline
|
|
Falls Efficacy Scale - International
大体时间：Clinical assessment at baseline
|
Fear of falling assessment tool which investigates fear of falling in 16 different activities.
Each activity is scored from 0 to 4 (4 representing an higher fear of falling in this activity).
The total score range from 16 to 64 (an higher score indicating a most severe fear of falling)
|
Clinical assessment at baseline
|
|
Number of anterior falls
大体时间：Clinical assessment at baseline
|
assessment of fall occurence in the last 12 months
|
Clinical assessment at baseline
|
|
General Practioner assessment of Cognition (GP-COG)
大体时间：Clinical assessment at baseline
|
assessment of cognitive function.
GP-COG gives a score from 0 to 9 (9 indicating a better cognitive function)
|
Clinical assessment at baseline
|
|
International Physical Activity Questionnaire (IPAQ short-form)
大体时间：Clinical assessment at baseline
|
assessment of daily physical activity and sedentarity
|
Clinical assessment at baseline
|
|
COPD assessment test (CAT)
大体时间：Clinical assessment at baseline
|
quality of life assessment tool
|
Clinical assessment at baseline
|
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：Graziella Brinchault, MD、University Hospital of Rennes
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 (预期的)
2022年2月1日
初级完成 (预期的)
2022年9月1日
研究完成 (预期的)
2023年4月1日
研究注册日期
首次提交
2021年11月23日
首先提交符合 QC 标准的
2022年1月14日
首次发布 (实际的)
2022年1月27日
研究记录更新
最后更新发布 (实际的)
2022年1月27日
上次提交的符合 QC 标准的更新
2022年1月14日
最后验证
2022年1月1日
更多信息
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.