跳至主要内容
临床试验/NCT02089815
NCT02089815已完成不适用

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

Mahidol University1 个研究点 分布在 1 个国家目标入组 439 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
439
试验地点
1
主要终点
number of falls

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Thai elderly aged 65 years or older
  • •able to communicate and follow the home-based exercise programme
  • •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
  • •non diagnosed with moderate to severe dementia or depression
  • •non diagnosed with parkinson disease
  • •non diagnosed with cerebrovascular disease with less than grade 4 hemiparesis.
  • •non diagnosed with acute arthritis or recent diagnosed within 6 months.
  • •informed and consent to participate in the study
  • •not participate in regular Tai-chi or Yoga exercise training.

排除标准

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

研究组 & 干预措施

Home based exercise

Experimental

simple designed home based exercise program

干预措施: Home based exercise (Behavioral)

Home based exercise

Experimental

simple designed home based exercise program

干预措施: fall prevention education and counseling (Other)

fall prevention education and counseling

Active Comparator

fall prevention education & counseling : home modification, vision screening, avoid sedative drugs use, proper shoes, report dizziness and fall to doctors

干预措施: fall prevention education and counseling (Other)

结局指标

主要结局

number of falls

时间窗: 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.

次要结局

  • muscle strength(baseline, 12 weeks and 24 weeks)
  • Balance(Baseline, 12 weeks and 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chitima Boongird

Doctor

Mahidol University

研究点 (1)

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