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Home Based Exercise in Preventing Fall and Improving Balance in Older People

2015年4月9日 更新者:Chitima Boongird、Mahidol University

Effectiveness of a Simple Designed Programme of Home Based Exercise in Preventing Fall and Improving Balance and Strength in Older People With Mild to Moderate Balance Dysfunction: A Randomized Controlled Trials

Prior studies have shown multifaceted falls prevention program with home-based exercise reduced falls significantly in the community setting. The Otago exercise program has been tested in four separated controlled trials of community living people in New Zealand. Falls were the main outcome in each trail and were defined as "unintentionally coming to rest on the ground, floor or other lower level". Not only this combination strengthening and balance training exercise could reduce fall but also could benefit in cost-effectiveness for fall prevention and decrease mortality in those 80 and older. However the limitation of Otago exercise program is that the program was needed to be trained by skill nurses or physical therapists. There are 17 steps levels to adhere the program. As some studies have shown that fall prevention program adherence could be as low as 10-40%. In Thailand the lack of medical staffs are continued the problem in the community. Therefore to establish fall prevention guideline that will be suitable and translated into the real setting, this study is aimed to test the effectiveness of simple program home-based exercise comparing to non-simple program home based exercise in preventing fall and improve muscle strength and balance dysfunction in older people with mild to moderate balance dysfunction. The method is the randomized controlled trails.

研究概览

研究类型

介入性

注册 (实际的)

439

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

      • Bangkok、泰国、10400
        • Ramathibodi Hospital, Mahidol University

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 及以上 (年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Thai elderly aged 65 years or older
  2. able to communicate and follow the home-based exercise programme
  3. mild to moderate balance dysfunctions as followings:

    • functional reach test score less than 26 cm.
    • five time sit to stand test more than 17.9 seconds
    • able to walk independently or walk with only single cane
  4. non diagnosed with moderate to severe dementia or depression
  5. non diagnosed with parkinson disease
  6. non diagnosed with cerebrovascular disease with less than grade 4 hemiparesis.
  7. non diagnosed with acute arthritis or recent diagnosed within 6 months.
  8. informed and consent to participate in the study
  9. not participate in regular Tai-chi or Yoga exercise training.

Exclusion criteria:

  1. Participants would like to withdraw from the study.
  2. severe injury occured after following simple designed exercise program eg. tendon injuries.

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
实验性的:Home based exercise
simple designed home based exercise program
modified Otago exercise program to simple designed home based exercise program
其他名称:
  • combination strengthening and balance training program
有源比较器:fall prevention education and counseling
fall prevention education & counseling : home modification, vision screening, avoid sedative drugs use, proper shoes, report dizziness and fall to doctors

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
number of falls
大体时间:1 year
Number of falls were measured at baseline, 12 weeks, 24 weeks and 1 year. At baseline, the participants will be interviewed the number of falls that occurred in the past 1 year period before enrollment.
1 year

次要结果测量

结果测量
措施说明
大体时间
muscle strength
大体时间:baseline, 12 weeks and 24 weeks

There are two Measurements as following:

  1. Five time sit to stand test The participant stood up and sat down as quickly as possible from standard chair (47 cm high) 5 times, with arms folded across the chest.
  2. Timed up and go test The time required to rise from a chair, walk 3 meters distance, turn around, walk back and sit down.
baseline, 12 weeks and 24 weeks
Balance
大体时间:Baseline, 12 weeks and 24 weeks
The participants will be tested their balances by using Short form of Berg Balance scale (7 items, 0-28 scores.)
Baseline, 12 weeks and 24 weeks

其他结果措施

结果测量
措施说明
大体时间
fear of falling
大体时间:baseline and at 24 weeks.
Thai Falls efficacy scale-international (FES-I)
baseline and at 24 weeks.
Quality of life
大体时间:1 year
The participants will be interviewed by using Thai EQ-5D questionaires.
1 year

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:Chitima Boongird, MD、Department of Family Medicine, Ramathibodi Hospital, Mahidol University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2013年8月1日

初级完成 (实际的)

2015年3月1日

研究完成 (实际的)

2015年3月1日

研究注册日期

首次提交

2014年3月10日

首先提交符合 QC 标准的

2014年3月17日

首次发布 (估计)

2014年3月18日

研究记录更新

最后更新发布 (估计)

2015年4月13日

上次提交的符合 QC 标准的更新

2015年4月9日

最后验证

2015年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • 01-56-37

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.

生活质量的临床试验

Home based exercise的临床试验

3
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