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临床试验/NCT01404299
NCT01404299已完成不适用

Effects of a Protein-Energy Nutritional Supplementation on the Functional Status of Frail Older Adults With Low Socioeconomic Status: A Community-based Randomized Trial

Gangbuk-gu Community Health Center2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2011年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
87
试验地点
2
主要终点
Functional Status

研究概览

简要总结

The purpose of this study is to determine whether protein-energy nutritional supplementation improves geriatric function in community-dwelling frail older adults of low socioeconomic status.

详细描述

Chronic undernutrition is a common condition in older people, and is clearly an important component of frailty. However, the effect of protein-energy nutritional supplementation on the functional status of frail older people is controversial. Some investigators suggested that, if nutritional or functional status has deteriorated too far, it could be very difficult for single nutritional supplementation to reverse malnutrition progression or functional decline.

The investigators believe one of the reasons for these ineffective results, especially for the community-dwelling frail elderly, may be due to a lack of regard to the socioeconomic status of the study population. For this reason, the investigators recruited a study sample with low socioeconomic status and evaluated the effect of protein-energy nutritional supplementation on their disability scores and physical performance.

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 (Outcomes Assessor)

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

  • Older adults over 65 years of age, registered in the National Home Healthcare Service database
  • Require more than 5 seconds to perform 3m walking test (Usual Gait Speed <0.6 m/sec)
  • Get less than 24 points on Mini Nutritional Assessment (Mini Nutritional Assessment <24)

排除标准

  • Unable to walk or are too functionally deteriorated to receive home health care services
  • Who were participating in any kind of exercise program or clinical nutrition program
  • who were restricted to a high-protein diet by an internist (i.e., for liver failure or severe renal failure)

结局指标

主要结局

Functional Status

时间窗: 12 weeks

Physical Functioning (Self-reported disability score which was specially developed to measure geriatric function in the community-dwelling frail elderly of Korea), Short Physical Performance Battery (Objective measurement of functional performance developed at the Established Population for Epidemiologic Studies of the Elderly)

次要结局

  • Nutritional Status, Other Functionality Test(12 weeks)

研究者

发起方
Gangbuk-gu Community Health Center
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Chang-O Kim

Home Visit Doctor

Gangbuk-gu Community Health Center

研究点 (2)

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