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临床试验/NCT02144506
NCT02144506已完成不适用

Tests and Exercises Home-based Program "T&E" for Fall Prevention and Quality of Life in Elderly: a Randomised Control Pilot-study

HES-SO Valais-Wallis1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2014年5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
18
试验地点
1
主要终点
Adhesion rate

研究概览

简要总结

The aim of the pilot-study is to evaluate the feasability of a future RCT, regarding recruitement of eligible participants, adhesion rate, datarecording and cost. In this feasibility pilot study, 18 patients with at least 65 years will be allocated randomly to one of two interventions. The control group gets a well-known home-based exercise program (OTAGO) aiming to prevent falls where the exercises are prescribed by a physical therapists. The exercises will be presented on a booklet and on printed cards. The Intervention group consists of an exercise program, the "T&E" program, where the elderly persons can choose the exercises depending on their abilities. The exercises in the "T&E" program will be presented in a printed manual and shown on videos on an electronic tablet. Both intervention groups receive 6 hours of instruction and control/supervision sessions by physical therapists. In addition, the participants will exercise alone.

The interventions will be performed over 24 weeks.

In this pilot study, the hypothesis is that the adhesion rate is at least 65%. Other feasibility criteria will be costs, data recording issues and the qualitative evaluation of the booklet and the tablet.

Falls will be assessed with a falls calendar. The amount of physical activity of the participants is assessed with an accelerometers (actigraph) and quality of life will be assessed with OPQOL-35 at baseline, week 16 and week 24.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •Living at home
  • •Ability to perform standing position independently with/without walking aids (rollator crutch)
  • •Reported fall(s) during the last 12 months and/or fear of falling (Short FES-I ≥8)
  • •Understand french / german

排除标准

  • •Actually in treatment with a physical therapist
  • •Participate at an other home-based programm exercises
  • •MMS Score ≥ 25.

研究组 & 干预措施

T&E

Experimental

Home-based exercises program "T&E".This exercise program proposes 50 exercises with a booklet, cards and an electronic tablet. The participants choose their exercises on the basis of a rating scale of perception of exercise difficulty.

干预措施: T&E (Other)

OTAGO

Active Comparator

Programm "OTAGO" is a home-based exercises program.

干预措施: OTAGO (Other)

结局指标

主要结局

Adhesion rate

时间窗: 24 weeks

Feasability of a futur study about the recruting processus and adhesion rate (≥ 65%)

次要结局

  • Feasability(24 weeks)

研究者

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

Mittaz Hager Anne-Gabrielle

Prof.

HES-SO Valais-Wallis

研究点 (1)

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