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临床试验/NCT04777279
NCT04777279已完成不适用

Physical Exercise and Nutrition Supplement on Improving Frailty, Depressive Symptoms, and Quality of Life in Community-dwelling Older Population

Taipei Medical University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年12月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
frailty score

研究概览

简要总结

This study is aimed to explore the effect of physical exercise and nutrition supplement on improving frailty, depressive symptoms, and quality of life in community-dwelling older population.

详细描述

Objective

This study is aimed to explore the effect of physical exercise and nutrition supplement on improving frailty, depressive symptoms, and quality of life in community-dwelling older population.

Methods: We conduct a quasi-experimental study to measure frailty, depressive symptoms, and quality of life before and after intervention. A total of 120 community-living older adults with frailty identified by Fried's phenotype method are assigned to four groups: physical exercise group, nutrition supplements group, physical exercise and nutrition supplements group, and control group. Each participants in the assigned group will receive 12 weeks intervention. Measurements include frailty (Fried's phenotype method), depressive symptoms (Geriatric Depression Scale-15, GDS-15), and quality of life (WHOQOL-BREF). Data analyses include describe statistics, Chi-square test, and Analysis of Variance. A Generalized estimating equations (GEE) will be used to examine the effect of physical exercise and nutrition supplement on improving frailty, depressive symptoms, and quality of life.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • older adults aged more than 60 years;
  • pre-frail stage: must have one item as frailty identified using the Fried's phenotype method;
  • normal cognition: AD8 score less than 2 points;
  • can communicate with Mandarin or Taiwanese.

排除标准

  • incapable of walk independent or using assistive devices (e.g., crutches);
  • a condition of having an acute disease, hemodialysis, or unable to engage in physical activity;
  • have history of unstable heart disease such as coronary heart disease, heart failure and hypertension without regular medication;
  • have regular physical activity (≥150 minutes weekly) such as aerobic dance, swimming, Tai Chi.

结局指标

主要结局

frailty score

时间窗: through study completion, an average of 12 weeks

Frailty will examined using Fried's phenotype method and higher score indicates more frailty

次要结局

  • Quality of Life score(through study completion, an average of 12 weeks)
  • Depressive symptoms score(through study completion, an average of 12 weeks)

研究者

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

Huang, Hui-Chuan

associate professor

Taipei Medical University

研究点 (2)

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