Evaluation of the Impact of a Personalized Program of Adapted Physical Activates in Patients With Parkinson Disease (ACTIPARK)
2020年1月23日 更新者：Centre Hospitalier Universitaire de Nīmes
Our study aims to compare the effects of a standard care plan to one using adapted physical activity in patients with Parkinson Disease.
Using actigraphy as an evaluation measure will allow the collection of quantitative and objective data related to activity in contrast to questionnaires which are more subjective and dependent on self-representation.
In addition, the evaluation of the caregiver's actigraphy and hardship (Zarit scale) will provide interesting data from this population.
研究概览
研究类型
介入性
注册 (实际的)
19
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
-
-
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Nîmes、法国、30029
- CHU Nimes
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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
40年 至 80年 (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:
- The patient and their carer have given their free and informed consent and signed the consent form
- The patient must be insured of the beneficiary of an insurance policy
- The patient is available for the 6 month follow-up
- The patient is between 40 and 80 years old
- The patient has experienced symptoms of Parkinson Disease for at least 5 years and is in a stable state (no medical event or change of treatment in at least 1 month)
- The functional impact and duration of fluctuations is ≥3 (MDS UPDRS)
- The patient can walk autonomously, including using a technical aid
- The patient does not have any regular physical activity excluding physiotherapy sessions
- The patient has daily help from a caregiver
Exclusion Criteria:
- The subject and/or their caregiver is participating in another study
- The subject and/or their caregiver is in a period of exclusion determined by a previous study
- The patients is under judicial protection or state guardianship
- It proves impossible to give the patient and/or the caregiver clear information
- The patients and/or the caregiver reuses to sign the consent form
- The patient is pregnant or breast feeding
- The patient has anxiety or depression (Score HAD≥ 11/14), cardiac or respiratory failure (stress test), vesico-sphincter problems preventing normal practice of a physical activity, a contraindication to adapted physical activities
- The patient cannot walk
- Muscular tremor preventing the actigraphy measurement. Outside normal range values for UPDRS measures of: 3.15) postural tremor of the hands; 3.16) action tremor of the hands; 3.17) amplitude of rest tremor
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：其他
- 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 |
|---|---|
|
无干预：标准护理
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|
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实验性的：Adapted physical activity
|
Targeted physical activity
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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 |
|---|---|---|
|
Evaluate the impact of an adapted physical activity (APA) program versus standard care on the activity of patients with Parkinson Disease
大体时间：3 months
|
previous weeks' activity measured by actigraphy
|
3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Activity of patients in both groups
大体时间：6 months
|
previous weeks' activity measured by actigraphy
|
6 months
|
|
Activity of patients in both groups
大体时间：6 months
|
assessed by international physical activity questionnaire
|
6 months
|
|
Quality of life of patients undertaking APA verses standard care
大体时间：3 months
|
Assessed by PDG-39 questionnaire
|
3 months
|
|
Quality of life of patients undertaking APA verses standard care
大体时间：6 months
|
Assessed by PDG-39 questionnaire
|
6 months
|
|
Risk of fall of patients undertaking APA verses standard care
大体时间：3 months
|
measured by Timed Up and Go test
|
3 months
|
|
Risk of fall of patients undertaking APA verses standard care
大体时间：6 months
|
measured by Timed Up and Go test
|
6 months
|
|
Risk of fall of patients undertaking APA verses standard care
大体时间：3 months
|
measured by Tinetti Falls Efficacy Scale
|
3 months
|
|
Risk of fall of patients undertaking APA verses standard care
大体时间：6 months
|
measured by Tinetti Falls Efficacy Scale
|
6 months
|
|
Risk of fall of patients undertaking APA verses standard care
大体时间：3 months
|
measured by 0-10 scale
|
3 months
|
|
Risk of fall of patients undertaking APA verses standard care
大体时间：6 months
|
measured by 0-10 scale
|
6 months
|
|
Endurance and speed of walking of patients undertaking APA verses standard care
大体时间：3 months
|
6 minute walk test
|
3 months
|
|
Endurance and speed of walking of patients undertaking APA verses standard care
大体时间：6 months
|
6 minute walk test
|
6 months
|
|
Activity of the care giver
大体时间：3 months
|
previous weeks' activity measured by actigraphy
|
3 months
|
|
Activity of the care giver
大体时间：6 months
|
previous weeks' activity measured by actigraphy
|
6 months
|
|
Evaluation of the care burden of care giver
大体时间：3 months
|
Zarit scale
|
3 months
|
|
Evaluation of the care burden of care giver
大体时间：6 months
|
Zarit scale
|
6 months
|
|
Grip strength
大体时间：Day 0
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Pinch test
|
Day 0
|
|
Grip strength
大体时间：6 months
|
Pinch test
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6 months
|
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Patient dependence
大体时间：Day 0
|
Activities of Daily Living
|
Day 0
|
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Patient dependence
大体时间：6 months
|
Activities of Daily Living
|
6 months
|
|
Level of dementia at Day
大体时间：Day 0
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Instrumental Activities of Daily Living
|
Day 0
|
|
Level of dementia at Day
大体时间：6 months
|
Instrumental Activities of Daily Living
|
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。
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1月10日
初级完成 (实际的)
2019年12月2日
研究完成 (实际的)
2019年12月2日
研究注册日期
首次提交
2017年6月16日
首先提交符合 QC 标准的
2017年8月7日
首次发布 (实际的)
2017年8月10日
研究记录更新
最后更新发布 (实际的)
2020年1月27日
上次提交的符合 QC 标准的更新
2020年1月23日
最后验证
2020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.
Personalized activity program的临床试验
-
Leiden University Medical CenterUMC Utrecht邀请报名
-
University of ManchesterNational Secretariat of Science, Technology and Innovation in Panama (SENACYT)完全的
-
University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
-
The University of Hong KongSydney Children's Hospitals Network; SAHK完全的
-
Ghana Health ServicesKwame Nkrumah University of Science and Technology尚未招聘戒烟 | 减少吸烟 | 吸烟，烟草 | 吸烟行为
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Weill Medical College of Cornell UniversityWeill Cornell Medical College in Qatar撤销