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临床试验/NCT02926105
NCT02926105Unknown3 期

Comparison of the Effects of Three Home-based Exercise Programmes Regarding Falls, Quality of Life and Exercise-adherence in Older Adults at Risk of Falling: Protocol for a Randomised Controlled Trial

HES-SO Valais-Wallis6 个研究点 分布在 1 个国家目标入组 405 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
3 期
入组人数
405
试验地点
6
主要终点
number of falls

研究概览

简要总结

This study compares the effects of three home-based exercise programmes in "at-risk to falling" older adults living in their own home on the incidence of falls (number and severity), risk factors, and quality of life as well as on the adherence to exercise. The subjects will be randomized and allocated in three groups. The group A will receive the "Test-and-Exercise" home-based programme (T&E), the group B will receive the "Otago" home-based exercise programme and the group C (activ-control group) will receive the "Helsana" booklet

详细描述

Home-based exercise programmes appear to reduce rate of falls, number of fallers, risk of falling and risk of death and to improve balance, leg strength, function, physical activity and balance confidence in older adults living in the community.

The Test-and-Exercise home-based programme (T&E) contains 50 tests and 50 exercises to improve balance, strength and ability in older adults. It is especially built for older adults and is based on the concept of self-efficacy and empowerment. The originality of this programme is the evaluation of the difficulty perceived of the balance-exercises. It is delivered on a booklet which investigators had good experience with in our pilot study, with pictures and descriptions of each test and each exercise. Investigators also developed a mobile application. This application will be transmitted on a tablet-computer. In addition, the participants will receive cards with pictures of the exercises, to put into a plastic sheet to have an overview of their own exercise programme. This programme will be implemented from especially trained physiotherapists.

The Otago home-based exercise programme was developed in New-Zeeland in the 2000's to prevent falls in older adults. It proposes 22 exercises and walk training. The physiotherapists give an exercise prescription at each home visit. It shows good results for decrease falls in older adults, but the exercise adherence decrease also with the time.

The Otago home-based exercise programme was developed in New-Zeeland in the 2000's to prevent falls in older adults. It proposes 22 exercises and walk training. The physiotherapists give an exercise prescription at each home visit. It shows good results for decrease falls in older adults, but the exercise adherence decrease also with the time.

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
Double (Investigator, 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

入选标准

  • 65 years old and older,
  • Living in their own home,
  • Having a history of fall in the previous 12 months or perceiving fear of falling (≥ 20 points on FES-I,
  • Being able to walk without auxiliary tools in their home.
  • Signed Informed Consent

排除标准

  • Having severe vision impairment that do not permit the reading of the exercise-programme booklet and that do not permit the completing of the monthly diaries,
  • Receiving physiotherapeutic treatment with balance learning,
  • Having cognitive impairment (<25 points on the Mini-Mental State Examination (MMSE) of Folstein

结局指标

主要结局

number of falls

时间窗: one year

次要结局

  • Risk of fall(one year)
  • Quality of life(one year)
  • Severity of falls(one year)
  • Exercise adherence(one year)
  • Fear of falling(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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