Effect of Body Suspension and Tilting Exercises in Parkinson's Disease
2016年11月24日 更新者：Pontificia Universidade Católica do Rio Grande do Sul
This study evaluates the effect of body suspension and tilting exercises (performed in Chordata apparatus) on the balance and mobility of subjects with Parkinson disease.
Half of patients will perform the exercise protocol while the other half will receive passive muscle stretching and maintain the usual routine.
研究概览
地位
完全的
条件
详细说明
Body suspension and tilting exercises performed in the Chordata equipment might be an effective option to improve trunk muscles activation and to facilitate functional balance and mobility control in Parkinson's disease (PD).
To evaluate this hypothesis, subjects will be randomized into control group or intervention group.
Intervention group will receive 30-minute session of body suspension and tilting exercises on the Chordata equipment (PI: 0804871-1 and BR 10 2012 009901-2) twice a week for eight weeks, while the control group will receive passive muscle stretching and maintained their usual routine during the same period.
Both groups will be assessed at baseline and immediately after the intervention protocol.
Finally, a follow-up evaluation will be performed 8 weeks after the protocol ending (to verify possible long-lasting effects of this exercise protocol).
研究类型
介入性
注册 (实际的)
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
-
-
Rio Grande do Sul
-
Porto Alegre、Rio Grande do Sul、巴西
- Serviço de Neurologia do Hospital São Lucas da PUCRS
-
-
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
65年 至 85年 (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:
- Subjects able to go to training or assessment places;
- Subjects that are agreement with the study protocol and sign the ;
- Subjects in stage I, II or III of Parkinson disease according to the Hoehn and Yahr scale.
Exclusion Criteria:
- Subjects do not keep their usual routine (apart of the research protocol);
- Subjects with physical or functional limitations that prevent the assessment test battery;
- Subjects with heart or lung diseases that prevent the exercise performance;
- Subjects with cancer;
- Subjects with major visual deficits;
- Subjects with recurrent vertigo;
- Subjects with uncontrolled systemic blood pressure.
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 |
|---|---|
|
实验性的：Intervention group
Subjects submitted to a 30-minute session of suspension and tilting exercises on the Chordata equipment (PI: 0804871-1 and BR 10 2012 009901-2) twice a week for eight weeks.
|
The body suspension and tilting exercise program (Chordata Method) involved suspending the body in the apparatus while performing tilting exercises.
The Chordata apparatus consists of a steel structure with special springs and a harness specifically manufactured for practicing the Chordata Method.
During the training sessions, the prescribed exercises emphasize the repetition of movements designed to promote different types of muscle contractions (concentric, eccentric, static) performed in different body positions and joint angles.
Thus, when using the method, patients experience maximal functional performance beyond to the body mass centre, activating trunk antagonist muscles and motor memory evocation.
Each session lasts 30 minutes.
其他名称：
|
|
假比较器：Control group
Subjects submitted to a 30-minute passive muscle stretching session twice a week for eight weeks.
|
Subjects receiving submitted a global muscle stretching session twice a week for eight weeks.
During this period.
All participants are requested to don't engage in any additional type of exercise program or physical activity throughout the study period.
其他名称：
|
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 |
|---|---|---|
|
Timed Up and Go Test
大体时间：At 8th week (in the end of exercise protocol).
|
Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down.
The person wears regular footwear and customary walking aid.
|
At 8th week (in the end of exercise protocol).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Berg Balance Test
大体时间：At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
|
The Berg Balance Scale (BBS) is a widely used clinical test of a person's static and dynamic balance abilities.
For functional balance tests, the BBS is generally considered to be the gold standard.
The test takes 15-20 minutes and comprises a set of 14 simple balance related tasks, ranging from standing up from a sitting position, to standing on one foot.
The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.
|
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
|
|
Functional Reach Test
大体时间：At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
|
The Functional Reach test can be administered while the patient is standing.
The patient is instructed to next to, but not touching, a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist.
The assessor records the starting position at the 3rd metacarpal head on the yardstick.
Instruct the patient to "Reach as far as you can forward without taking a step."
The location of the 3rd metacarpal is recorded in centimetre (cm).
Scores are determined by assessing the difference between the start and end position is the reach distance.
Three trials are done and the average of the last two is noted.
|
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
|
|
Baropodometry (Stabilometric parameters)
大体时间：At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
|
In the test protocol adopted data uptake of the examination will be assessed walking on the pressure platform (dynamic measure) and stopped on the pressure platform with opened eyes (static measure).
|
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
|
|
Unified Parkinson Disease Rating Scale (UPDRS)
大体时间：At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
|
The UPDRS is a rating tool to follow the longitudinal course of Parkinson's Disease.
It is made up of the 1) Mentation, Behavior, and Mood, 2) ADL and 3) Motor sections.
These are evaluated by interview.
Some sections require multiple grades assigned to each extremity.
A total of 199 points are possible.
199 represents the worst (total) disability), 0--no disability.
|
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
|
|
Parkinson's Disease Questionnaire (PDQ-39)
大体时间：At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
|
The Parkinson's Disease Questionnaire (PDQ-39) is primarily used in clinical trials of therapeutics intended to benefit individuals with Parkinson's disease.
|
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
|
|
Timed Up and Go Test
大体时间：At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
|
Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down.
The person wears regular footwear and customary walking aid.
The investigators will measure the "change" at different time frames.
|
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hoehn and Yahr Staging of Parkinson's Disease
大体时间：This test will be performed just at baseline (to classify the subjects).
|
The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress.
|
This test will be performed just at baseline (to classify the subjects).
|
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
- 学习椅：Irênio G da Silva Filho, PhD、Pontificia Universidade Católica do Rio Grande do Sul
- 学习椅：Carlos Roberto M Rieder, PhD、Hospital de Clinicas de Porto Alegre
- 研究主任：Régis G Mestriner, PhD、Pontificia Universidade Católica do Rio Grande do Sul
- 首席研究员：Charlene B de Oliveira, MSc、Pontificia Universidade Católica do Rio Grande do Sul
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
2015年9月1日
初级完成 (实际的)
2016年5月1日
研究完成 (实际的)
2016年5月1日
研究注册日期
首次提交
2016年4月28日
首先提交符合 QC 标准的
2016年5月4日
首次发布 (估计)
2016年5月5日
研究记录更新
最后更新发布 (估计)
2016年11月28日
上次提交的符合 QC 标准的更新
2016年11月24日
最后验证
2016年11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.