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临床试验/NCT05935319
NCT05935319已完成不适用

The Effectiveness of a VIVIFRAIL Program in Improving the Frailty and Physical Function in the Elderly

National Taipei University of Nursing and Health Sciences1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年5月26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
200
试验地点
1
主要终点
Mini-Mental State Examination(MMSE)

研究概览

简要总结

The global population is aging, and Taiwan has become an aging society. The aging population continues to rise. When the physical function and mental state of the elderly gradually decline, it is easy for the elderly to enter a state of physical weakness. Weakness is the decline in the reserve capacity of the physiological system. It is also related to geriatric syndrome, causing falls, hospitalization, disability, death, and increased medical costs, burden on primary caregivers, and reduced quality of life for the elderly.

Physical exercise training has been considered to be an effective strategy to prevent and delay disability and frailty, so this study uses the Vivifrail program for the elderly. A family-based 12-week exercise program, including: resistance, strength, balance, flexibility and cardiorespiratory endurance exercise training, performed five days a week, at least 45-60 minutes each time, so that the elderly can exercise at home, It can also improve physical function and improve the quality of life.

This study adopts a randomized controlled trial (RCT) with a one-group pretest-posttest design, with pre-frail and frail elderly as the research objects, and uses comprehensive assessment of the elderly to understand the physical function of the elderly Status, Vivifrail for the elderly was provided for abnormal physical function items, and post-test evaluation was carried out 4 weeks and 12 weeks after the intervention. In Taiwan, there is no research on Vivifrail for the frail elderly. In view of this, it is hoped that through the Vivifrail program and the follow-up of case managers, multi-faceted and continuous integrated care can be provided. Improve and maintain the physical function of the frail elderly for reference in the daily care of the elderly in the future.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

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 above.
  • Pre-frail and frail cases assessed by Frail Fried's frail phenotype.
  • Clear consciousness, willing to accept interviewers, able to communicate in Chinese and Taiwanese.
  • Those who can cooperate with physical activities and have ADL ≥ 60 points.

排除标准

  • Those who cannot cooperate with the interventional care plan.
  • Elderly who are seriously ill or terminally ill.
  • People living in institutions.
  • Incompatibility and exclusion: acute myocardial infarction or recent unstable angina, poorly controlled atrial or ventricular arrhythmia, dissected aortic aneurysm, severe aortic stenosis, endocarditis/acute cardiac Capsulitis, uncontrolled hypertension, acute thromboembolism, acute or severe heart failure, acute or severe respiratory failure, uncontrolled postural hypotension, acute incompensated diabetes mellitus, or uncontrolled hypoglycemia, past month There is a fracture (muscle strength training).

研究组 & 干预措施

experimental group

Experimental

Vivifrail

干预措施: Vivifrail (Other)

control group

No Intervention

Traditional Sports Health Leaflet

结局指标

主要结局

Mini-Mental State Examination(MMSE)

时间窗: 10-20 minutes

junior high school ≧ 24 points, elementary school ≧ 21 points, those without education ≧ 16 points.

Activities of Daily Living(ADL)

时间窗: 2-5 minutes

The full score is 100 points, 0-20 points are completely dependent, 21-60 points are heavily dependent, 61-90 points are moderately dependent, 91-99 points are slightly dependent, and 100 points are completely independent.

Instrumental Activities of Daily Living(IADL)

时间窗: 2-5 minutes

The full score is 8 points, the higher the score, the better the function.

Geriatric Depression Scale(GDS- 15)

时间窗: 10-20 minutes

The full score is 15 points, 0-4 points are normal, 5-9 points are mild depression, 10-14 points are moderate depression, and more than 15 points are depression.

Hand Grip

时间窗: 1-2 minutes

Grip strength defined as \<28 kg for men and \<18 kg for women

Short Physical Performance Battery(SPPB)

时间窗: 5-10 minutes

≦9 points abnormal, 10-12 normal.

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

WangJiaJie

Principal Investigator

Mennonite Christian Hospital

研究点 (1)

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