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临床试验/NCT05655871
NCT05655871Enrolling By Invitation不适用

Investigation of the Effect of Nurse-led Transtheoretical Model-Based Video Exercise Trainings on Fall Risk to Elderly People Living in a Nursing Home

Kastamonu University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
44
试验地点
2
主要终点
Tinetti Balance and Gait Test

研究概览

简要总结

The aim of this study is to examine the effect of video exercise trainings based on transtheoretic model given to elderly individuals living in nursing homes under the leadership of nurses on the risk of falling in elderly individuals within nursing care programs.

详细描述

The aim of this study is to examine the effect of video exercise trainings based on transtheoretic model given to elderly individuals living in nursing homes under the leadership of nurses on the risk of falling in elderly individuals within nursing care programs.

This study was designed as a randomized controlled experiment. The population of the research consists of individuals aged 65 and over living in Tosya Nursing Home Elderly Care and Rehabilitation Center.

Sample size was calculated using the "G.Power-3.1.9.2" program at a 95% confidence level. As a result of the analysis, α=0.05, standardized effect size was taken from Cohen for the analysis of variance in repeated measurements with factor, due to the lack of a previous study, with a theoretical power of 0.25 to 0.95, the minimum sample size was 36 people in total, 18 control subjects. It was calculated as 18 intervention groups. However, considering that there may be data losses in the study, it was planned to recruit a total of 44 people, 22 of whom were in the control group and 22 in the intervention group, who met the inclusion criteria.

Inclusion criteria in the study

  • Individuals aged 65 and over who volunteered to participate in the research
  • Those with a Mini Mental Test (MMT) score ≥24
  • Those with a KATZ daily living activities scale score of 6
  • Does not have a cognitive/affective problem that may hinder communication Exclusion criteria from the study
  • Those who have a chronic disease and cannot control it with medication (Individuals will be followed in their files.) Exclusion criteria
  • The individual's desire to leave the research
  • The individual has a condition that requires hospitalization
  • The individual does not participate in video exercise trainings three times a week in a row.
  • Death of the individual Simple randomization method was used while forming intervention and control groups in our study. In this randomization method, individuals who meet the inclusion criteria can be assigned to the groups completely randomly, with equal probability, and independently of the previous assignment, after participating in the study. Computer-assisted randomization method was used in simple randomization. For this method, the https://www.randomizer.org/ page was used and intervention and control groups were created.

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
Double (Participant, Outcomes Assessor)

盲法说明

When creating groups in the study, the participants learned which group they belonged to, and blinding was done when the data was sent to the statistician for analysis.

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

  • Individuals aged 65 and over who volunteered to participate in the research
  • Those with a Mini Mental Test (MMT) score ≥24
  • Those with a KATZ daily living activities scale score of 6
  • Does not have a cognitive/affective problem that may hinder communication
  • Exclusion criteria from the study
  • Those who have a chronic disease and cannot control it with medication (Individuals will be followed in their files.) Exclusion criteria
  • The individual's desire to leave the research
  • The individual has a condition that requires hospitalization
  • The individual does not participate in video exercise trainings three times a week in a row.
  • Death of the individual

排除标准

  • 未提供

结局指标

主要结局

Tinetti Balance and Gait Test

时间窗: Three weeks

Three values are given in the scoring of the Tinetti Balance and Gait Test, 0 -1-2. 0 points represents the maximum impairment (not being able to perform the movement), 1 point represents the adaptation of the specified movement, 2 points independence (the movement is done as desired). Individual scores are then combined to form three measures, the overall gait assessment score, the overall balance assessment score, and the sum of the gait and balance scores. The maximum score that can be obtained for the walking assessment is 12. The maximum score that can be obtained for the balance assessment is 16. The maximum total score that can be obtained from the Tinetti Balance and Gait Test is 28. In general, a total score of ≤18 indicates a high risk of falling, a range of 19-24 indicates a medium fall risk and a score of ≥24 indicates a low risk of falling.

Exercise Stages of Change Scale

时间窗: Three weeks

It consists of 5 stages: not thinking, thinking, preparing, acting and continuing.

次要结局

  • Exercise Self-Efficacy Scale(1st week, 9th week and 12th week)
  • Exercise Decision Making Scale(1st week, 9th week and 12th week)
  • Exercise Change Process Scale(1st week, 9th week and 12th week)

研究者

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

Ayse Ozdemir

lecturer

Kastamonu University

研究点 (2)

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