跳至主要内容
临床试验/NCT04358653
NCT04358653已完成不适用

The Effectiveness of Group Intervention Exercise on Fall Risk Factors Reduction in Community-Dwelling Older Adults

University of Thessaly1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年10月3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
50
试验地点
1
主要终点
Upper Limb Strength

研究概览

简要总结

Objective: To assess the effectiveness of an intervention exercise program on enhancing fall risk deterrent factors, such as balance, postural control, overall strength, functionability in community-dwelling individuals.

Design: Single-blinded randomized controlled trial, comparing two groups, with follow-ups at the begging and 15 days after the completion of the program

Setting: Nursing homes in Ano Volos and Kanalia

Participants: A total of 40 elderly people, both male and female, aged 65 years and older were randomly assigned to an intervention exercise group (n = 20) and a control group (n = 20).

Interventions: Intervention exercise program consisted of two sessions each week for 8 consecutive weeks. The control group received no exercise intervention.

Measurements: Main outcomes were measured by the Timed Up and Go Test, Berg Balance Scale, 10-second chair stand test, Saehan hand grip dynamometer, Upper and Lower Limp reach tests.

详细描述

Methods Research design

A single - blind, randomized controlled trial design was used to examine the effects of a fall prevention exercise program in reducing fall incidence and fall risks for community-dwelling older adults at a risk for falls. The study was approved by the ethics committee of University of Thessaly.

Sample Forty (40) community dwelling elderly individuals, both males and females, were recruited from nursing homes. Convenience sampling was used. Subject eligibility criteria were: a) 65 years of age and older, b) absence of serious health problems or neurological diseases, c) absence of dementia, d) no recent surgeries. Out of the 40 subjects meeting the above criteria, 20 were randomly assigned to the control group (mean age 79.3±5.49) and 20 to the rehabilitation group (mean age 79.6±7.38). In both groups, 10 subjects reported at least one incidence of falling during the past year whilst the remaining 10 the absence of any.

Base line assessment A structured questionnaire was used to record a) anthropometric and demographic data (age, weight, height, profession etc.), b) comorbid medical conditions (e.g., hypertension, diabetes mellitus, cardiovascular disease, psychiatric illness), c) prescribed medications including psychotropic medications (antidepressants, and sedative hypnotics), d) use of walking aids, e) prior history of falls and fall-related injuries during the past year, f) prior surgeries

Procedure

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

入选标准

  • Community-Dwelling Older Adults >65 years old

排除标准

  • absence of neurological diseases
  • absence of dementia
  • no recent surgeries.

研究组 & 干预措施

fall prevention exercise program

Experimental

The experimental group was designed to undergo supervised exercise 2 days a week for 8 consecutive weeks for 45-50 min/session. The intervention program was implemented at the nursing home facilities.

干预措施: fall prevention exercise program (Other)

Control Group

No Intervention

The control group did not receive any intervention during that period and were instructed to pursue their habitual daily life activities.

结局指标

主要结局

Upper Limb Strength

时间窗: 8 weeks

Upper Limb Strength was measured using the SAEHAN hand grip dynamometer. The subject was sitting on a standard chair with the elbow flexed at 900. When the subject was ready, he would begin to strain the device in a maximal isometric effort, maintaining, at the same time, high concentration, as this was a required condition for maximal results. No other body movement was allowed during testing.

Mobility

时间窗: 8 weeks

Mobility was assessed using the Time Up \& Go Test (TUG) which was measured by recording the time taken to stand up from a standard chair (43cm), walk 3m at a natural pace, turn around, and sit back down in the chair. Expected time for the completion of this task is estimated at 7-10''. (Viccaro et al 2011)

Lower Limb strength

时间窗: 8 weeks

Lower Limb's strength was assessed through the "sit to stand 10" trial. Subjects were asked to sit on a chair, stand up and return to the sitting position for 10 consecutive times at full speed, with no intervals between. Normal time expected for the successful completion of the trial was estimated at 24"-27"

Functional balance

时间窗: 8 weeks

Functional balance was assessed with the Berg Balance Scale that has been developed to measure an elderly person's static and dynamic balancing abilities. It is composed of a total of 14 items and a full score of 56 points. The time required is around 15 minutes. Higher scores indicate better degrees of balance. Based on the total score participants are classified in: a) need for a wheelchair (0-20 points), b) need of aiding tools to walk (21-40 points), c) independent (41 points or higher). Persons with scores of 40 points or higher are not likely to fall (Berg et al., 1992 ; Bogle \& Newton 1996; Downs et al 2013)

Upper Body Flexibility

时间窗: 8 weeks

Upper Body Flexibility assessment, subjects were instructed to bring their hand back as high as possible in order to reach the A7 vertebra. The distance between the thumb and the A7 vertebra was measured (Collins et al 2004)

Lower Body Flexibility

时间窗: 8 weeks

Lower Body Flexibility was assessed using a modified Sit and Reach test. This test was performed in a standard chair with one leg fully extended and the other in a flexed position. Participants reached forward with one hand as far as possible and held this position for three seconds. Distance between fingers and toes was measured.

次要结局

未报告次要终点

研究者

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

Garyfallia Pepera

Assistant Professor

University of Thessaly

研究点 (1)

Loading locations...

相似试验