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临床试验/NCT04787432
NCT04787432Unknown不适用

The Effect of Salutogenic Model Based Frailty Prevention Program on Development of Frailty and Sense of Coherence in Women Aged 55 Years and Over

Istanbul University - Cerrahpasa (IUC)0 个研究点目标入组 84 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
84
主要终点
Change in FRAIL scale

研究概览

简要总结

Frailty is a condition of reduced the capacity in multiple body systems and causing adverse outcomes because of decreasing the ability to cope with stressors. Female sex, the changes of the body imposed by ageing, and coping strategies for stressors are causal mechanisms in the development of frailty. This project is designed with the salutogenic model that is focused on the concepts of health, stress, and coping. The aim of this project is to assess the effect of Salutogenic Frailty Prevention Program on promoting sense of coherence and preventing the development of frailty in women aged 55 years and over

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
Single (Participant)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Willing to participate in the study
  • Woman aged 55 years and over
  • Pre-frail (Total FRAIL scale score 1 or 2)
  • Has Internet access

排除标准

  • To be semi-dependent and dependent according to the Katz Daily Activities Activity Scale
  • To have any cognitive, psychiatric and neurological disorders
  • To have any surgical operation in the past 3 month
  • Communication barrier (due to hearing/vision impairment)

结局指标

主要结局

Change in FRAIL scale

时间窗: Baseline, 3 months, 6 months, 9 months

The FRAIL scale consists of 5 items (fatigue, resistance, ambulation, illnesses, loss of weight). Frail scale scores range from 0-5 and represent frailty status as frail (3-5), pre-frail (1-2), and robust (0).

Change in Sense of Coherence

时间窗: Baseline, 3 months, 6 months, 9 months

Sense of coherence assesses an individual's orientation and internal strengths. It consists of 13 items rated on a 7-point Likert scale, and has three components including comprehensibility (5-item), manageability (4-item) and meaningfulness (4-item)

次要结局

  • Change in fear of fall(Baseline, 3 months, 6 months, 9 months)
  • Change in number of emergency admissions(Baseline, 3 months, 6 months, 9 months)
  • Change in The World Health Organisation- Five Well-Being Index (WHO-5)(Baseline, 3 months, 6 months, 9 months)
  • Change in health-related quality of life(Baseline, 3 months, 6 months, 9 months)
  • Change in EQ-VAS(Baseline, 3 months, 6 months, 9 months)
  • Change in number of falls(Baseline, 3 months, 6 months, 9 months)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve ALTINER YAS

Research Assistant

Istanbul University - Cerrahpasa (IUC)

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