Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis
2017年4月4日 更新者：Eva Segura Ortí、Cardenal Herrera University
Comparison of Intradialytic Versus Home-based Programmes on Adherence and Strength of Stage 5 Chronic Kidney Disease Patients
Although exercise training of haemodialysis patients is associated with generally positive outcomes few haemodialysis units routinely offer intradialytic exercise therapy.
This is often related to financial cost and/or staffing limitations.
Home-based programs could be an alternative means of providing exercise benefits without associated implementation costs The aim of this study was to compare the effects of 4 weeks intradialytic versus home based exercise for haemodialysis patients regarding adherence and strength gains.
研究概览
研究类型
介入性
注册 (实际的)
60
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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Valencia
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Moncada、Valencia、西班牙、46113
- Universidad CEU Cardenal Herrera
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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
18年 至 90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:
- people under hemodialysis treatment at least 3 months
- be medicable stable
- complete all the physical tests
Exclusion Criteria:
- heart stroke in the previous 6 weeks of the study
- inferior limb amputation without artificial aids
- cerebral vascular disease (ictus, ischemic)
- disability to complete functional tests
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：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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其他：Intradialytic exercise
Exercise during hemodialysis
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其他：Home-based exercise
Exercise at home
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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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Change from Baseline Short Physical Performance Battery at 4 months
大体时间：At the beginning and after 4 months
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Assess lower extremity, which includes objective performance-based measure of balance (side-by-side, semi-tandem and tandem), endurance (4m gait speed) and strength (five chair stands).
Each component was scored from 0 to 4 and when summed yielded Short Physical Performance Battery scores between 0 (poor) and 12 (best).
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At the beginning and after 4 months
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Change from Baseline One leg standing test at 4 months
大体时间：At the beginning and after 4 months
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Consist in maintain one leg stance for as long as possible.
The test was considered normal if the one leg standing time reached 45 seconds.
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At the beginning and after 4 months
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Change from Baseline Timed Up and Go test at 4 months
大体时间：At the beginning and after 4 months
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To stand up from a standard arms chair, walk 3 meters, turn back the cone walk back and sit down to the chair.
The time in seconds is record.
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At the beginning and after 4 months
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Change from Baseline Sit to stand to sit 10 and 60 at 4 months
大体时间：At the beginning and after 4 months
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For the Sit To Stand 10 participant has to stand up and sit down 10 times and the time needed is record; while for the Sit to stand to sit 60 the participant consist in measures how many repetition the participant can to stand up and sit down during 60 seconds
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At the beginning and after 4 months
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Change from Baseline One leg heel rise at 4 months
大体时间：At the beginning and after 4 months
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It measures the strength in the triceps surae in the one leg standing position and has to rise the heel.
It measures how many repetitions the participants is can do
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At the beginning and after 4 months
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Change from Baseline Handgrip Strength at 4 months
大体时间：At the beginning and after 4 months
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To measure the amount of strength developed by each hand in kg
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At the beginning and after 4 months
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Change from Baseline Six minutes walking test at 4 months
大体时间：At the beginning and after 4 months
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To walk the longest distance possible in 6 minutes by walking continuously the 20 or 30 metres indicated on the floor.
It measures the distance in meters
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At the beginning and after 4 months
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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。
调查人员
- 首席研究员：Eva Segura Ortí、Lecturer in the Cardenal Herrera University
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
2014年9月1日
初级完成 (实际的)
2016年12月1日
研究完成 (实际的)
2017年1月1日
研究注册日期
首次提交
2016年7月8日
首先提交符合 QC 标准的
2016年7月11日
首次发布 (估计)
2016年7月14日
研究记录更新
最后更新发布 (实际的)
2017年4月5日
上次提交的符合 QC 标准的更新
2017年4月4日
最后验证
2017年4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.
Exercise programmes的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的