Circle Dance for Family Caregivers of the Elderly With Alzheimer. (CircleCare)
2019年3月21日 更新者：Julimara Gomes dos Santos、Universidade Federal de Sao Carlos
Brazilian Circle Dance Program for Family Caregivers of the Elderly With Alzheimer's Disease (CircleCare): a Single-blind, Parallel-group Randomized Controlled Trial
The primary objective of this research is to compare the effects of a 12-week CircleCare on physical functioning of family caregivers of the elderly with AD.
Effects on cognition, psychosocial and frailty-related aspects (secondary objective).
The acute effect of one circle dance session on mood states (tertiary objective).
This randomized controlled trial will involve 40 family caregivers over 50 years old allocated into a control group or an intervention group of 12-weeks (twice a week, 60 min per session) of CircleCare.
Primary outcomes will include balance, speed of gait, lower limb muscle strength, functional mobility and risk of falls.
Secondary outcomes will include cognition, burden, stress, depression, quality of life and frailty.
Mood states will be a tertiary outcome.
The effects of CircleCare will be verified with an ANOVA two-way test and a multiple comparison test when necessary.
The analyzes will follow an intention-to-treat approach.
The change in moods will be evaluated by the paired t-test.
The level of significance will be set at p<0.05.
This study may guide professionals and health policymakers in deciding whether to implement this type of intervention.
If positive effects are demonstrated, this program can be offered in public health services to other groups, given its low cost.
研究概览
研究类型
介入性
注册 (预期的)
40
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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SP
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Sao Carlos、SP、巴西、13566-544
- 招聘中
- Julimara Gomes dos Santos
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接触：
- Julimara G Santos, PhD
- 电话号码：+5533991132227
- 邮箱：julimaraefi@yahoo.com.br
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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
50年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 50 years or older.
- Family caregiver for at least 6 months of an elderly person with Alzheimer's disease.
- Ability to walk without the help of another person.
Exclusion Criteria:
- Cardiopulmonary or orthopaedic contraindication to the practice of physical exercise.
- Severe visual or hearing deficiency that impedes participation in the intervention and assessments.
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：支持治疗
- 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 |
|---|---|
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实验性的：Circle Dance Program (CircleCare)
Caregivers (n=20) allocated to the experimental group will participate in 12-week CircleCare twice a week (24 sessions), for 60 min each session.
The planning and conduction of the intervention will be the responsibility of the researcher, a Fitness Professional with training in Circle Dance, called focalizer.
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Circle Dances derives from folk dances, but their current repertoire encompasses traditional and contemporary dances from diverse nations and cultures around the world.
Most of the choreographies are danced with the participants placed in a circle, holding hands, repeating a pattern of steps to the rhythm of the music.
其他名称：
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无干预：Control group
Caregivers (n=20) of this group will not receive the intervention, participating only in the assessment protocol.
They will be instructed not to initiate any regular exercise program during the study period.
At the end of the study, the same CircleCare applied to the experimental group will be offered to the interested of the control group.
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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 |
|---|---|---|
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Brazilian Version of the Short Physical Performance Battery
大体时间：Baseline and 12 weeks after randomization.
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Battery tests that evaluate the static balance; the speed of gait and lower limb muscle strength.
Each test ranges from zero to four points, and the total score is obtained by summing the score of each test, ranging from zero to 12 points.
The result can receive the following graduation: 0 to 3 points: incapacity or very poor performance; 4 to 6 points: low performance; 7 to 9 points: moderate performance; 10 to 12 points: good performance.
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Baseline and 12 weeks after randomization.
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Timed Up and Go Test
大体时间：Baseline and 12 weeks after randomization.
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Test that evaluates the basic functional mobility through the time spent to get up from a chair with arms, walk 3 meters and return to the chair, as well as the number of steps required to perform the activity.
The shorter the time to perform the task, the better the mobility index.
The 12.47 second cutoff point will be used as an indicator of the risk of falls.
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Baseline and 12 weeks after randomization.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Addenbrooke's Cognitive Examination-Revised (ACE-R)
大体时间：Baseline and 12 weeks after randomization
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Portuguese version of the Instrument that evaluates the global cognitive function through individual tests of orientation and attention (18 points), memory (26 points), verbal fluency (14 points), language (26 points) and spatial visibility skills (16 points).
The overall score ranges from zero to 100 points.
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Baseline and 12 weeks after randomization
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Zarit Burden Interview (ZBI)
大体时间：Baseline and 12 weeks after randomization
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An instrument that evaluates the physical, psychological and social impact of the task of caring for a patient with mental illness.
The scale is composed of 22 questions, whose scores can range from 0 to 88 points.
A score below 21 points is classified as no burden; of 21 and 40 points indicate a moderate burden; between 41 to 60, moderate to severe burden and ≥ 61 points, a severe burden.
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Baseline and 12 weeks after randomization
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Brazilian Perceived Stress Scale (BPSS-10)
大体时间：Baseline and 12 weeks after randomization
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PSS-10 is used to assess the level of stress perceived by older adults in the last month.
The final score ranges from 0 to 40, with higher scores denoting a greater degree of perceived stress.
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Baseline and 12 weeks after randomization
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Geriatric Depression Scale (GDS-15)
大体时间：Baseline and 12 weeks after randomization
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Scale composed of 15 negative/affirmative questions that evaluate the presence of depressive symptoms in the elderly.
Scores higher than 5 points indicate the risk of depression.
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Baseline and 12 weeks after randomization
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Quality of Life Scale in Alzheimer's disease (QoL-AD - caregiver's version)
大体时间：Baseline and 12 weeks after randomization
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Scale structured in three versions that relate to the quality of life of the elderly, careAn instrument adapted, translated and validated for the Brazilian culture to assess the quality of life of caregivers and elderly with AD.
In this version the caregiver to assess his/her own quality of life.
The score ranges from 13 to 52 points and the lower the score worse is the quality of life.
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Baseline and 12 weeks after randomization
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Frailty Phenotype
大体时间：Baseline and 12 weeks after randomization
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A battery of tests proposed by Fried et al. (2001) that asses unintentional weight loss (10 lbs in the past year), self-reported exhaustion, weakness (grip strength), slow walking speed, and low physical activity.
Participants with three or more criteria will be classified as frail.
Those with one or two criteria, pre-frail.
"No frail" will correspond to the absence of these criteria.
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Baseline and 12 weeks after randomization
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Illustrated and Reduced Mood States List (MSL-IR)
大体时间：After randomization, at the beginning and end of the first CircleCare session.
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Scale that evaluates the intensity of positive and negative moods represented by 14 "smile" faces.
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After randomization, at the beginning and end of the first CircleCare session.
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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9月6日
初级完成 (预期的)
2019年6月14日
研究完成 (预期的)
2019年7月1日
研究注册日期
首次提交
2017年3月2日
首先提交符合 QC 标准的
2017年3月10日
首次发布 (实际的)
2017年3月16日
研究记录更新
最后更新发布 (实际的)
2019年3月25日
上次提交的符合 QC 标准的更新
2019年3月21日
最后验证
2019年3月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
At the end of the study, caregivers will be individually informed about their performance in the assessments, but your personal data will not be shared with others, respecting your privacy and anonymity.
However, the analyzed results will be published in papers, reported in congresses and special interest groups such as groups of Alzheimer's caregivers and health units interested in implementing the circle dances as a health promotion activity.
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.