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临床试验/NCT04574271
NCT04574271已完成不适用

Multidimensional Intervention Directed to Pre-frail Patients Older Than 70 Years from Primary Care in a Basic Semi-urban Health Area

Endocrinology and Clinical Nutrition Research Center, Spain2 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2019年6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
340
试验地点
2
主要终点
Fall Risk by test up and go

研究概览

简要总结

Aging represents a huge advance in society and a health and social challenge. Spain has one of the highest life expectancies in the world, but other countries with the same demographic characteristics are ahead of us in quality adjusted life years. Primary care setting has the main drivers of healthy aging, acting on the early stages of pre-frailty and frailty.

Therefore, it is proposed a multicomponent intervention (nutritional and prescription of physical exercise) in patients older than 70 years of the Medina del Campo Health Center, with pre-frailty criteria, in order to measure the changes that this intervention produces in their mild dysfunction and whether it is capable of reversing it or delaying the progression to a state of frailty.

详细描述

Hypothesis: A balanced diet, with a sufficient protein intake for each patient based on the Mediterranean diet, as well as the performance of multicomponent exercise 3 times a week, delays the evolution to stages of dysfunction or disability in the pre-frail population.

Objective:

  • The main objective is to evaluate the effect of an intensive nutritional dietary treatment on the function markers in a sample of elderly people in a situation of pre-frailty.
  • To Demonstrate the equivalence of the values obtained in terms of functional improvement through adequate exercise and diet in urban populations in a semi-urban population.
  • To evaluate the change in analytical markers that indicate pre-frailty in patients under intensive dietary-nutritional treatment.
  • To Study the improvement of quality of life in individuals with adequate nutrition and level of physical exercise in those over 70 years of age in pre-frailty stages, increasing the prevalence of healthy aging in our study population.

Methods:

  • Design: This is a quasi-experimental study with a control group. Recruitment will be carried out, through random sampling, of patients over 70 years of age from the basic health area of Medina del Campo Urbano, detecting those who meet Fried's pre-frailty criteria, through the FRAIL questionnaire, being positive for pre-frailty fulfilling 1 or 2 criteria. These subjects detected as pre-frail will be randomly included in different multicomponent programs. In a group, two types of interventions will be carried out by the research team from primary care: Dietary advice adjusted to the needs of the patient and their pre-frailty stage, with an adequate nutritional and protein intake, based on the scientific evidence existing to date and in collaboration with the Clinical Hospital of Valladolid, Spain; and a multicomponent physical exercise prescription (elasticity, strength, resistance and balance), of at least 150 minutes per week, according to the WHO recommendations for this age group, adapting it individually, to be performed 3-5 times per week. Both branches of the intervention will be carried out through periodic interviews throughout a year of follow-up.

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
None

入排标准

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

入选标准

  • Non-institutionalized patients over 70 years of age from the basic health area of Medina del Campo Urbano, who meet pre-frailty criteria (1 or 2 Fried criteria).

排除标准

  • Cognitive impairment
  • Frailty syndrome
  • Moderate-Severe Dependence
  • Life Expectancy less than 6 months or patients in palliative care

结局指标

主要结局

Fall Risk by test up and go

时间窗: 12 months

Functional tests of frail syndrome diagnosis in elder patients (\<10 seconds: low fall risk; 10-20 seconds: fragility (risk of fall); \>20 seconds: high risk of fall).

The Lawton Instrumental Activities of Daily Living (IADL) Scale

时间窗: 12 months

Functional tests of frail syndrome diagnosis in elder patients (Grade of depedence: \<20: Total; 20-35: Severe; 40-55: Moderate; \>60: Mild; 100: Independent).

Barthel Test for dependency

时间窗: 12 months

Functional tests of frail syndrome diagnosis in elder patients

Functional assessment by Fried Criteria

时间窗: 12 months

Test of frail syndrome diagnosis in elder patients (Three out five criteria)

次要结局

  • Mini-Mental Test(12 months)
  • Short Form 36 (SF-36) Health survey Questionnaire(12 months)

研究者

发起方
Endocrinology and Clinical Nutrition Research Center, Spain
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel de Luis Roman

Professor, MD, PhD

Endocrinology and Clinical Nutrition Research Center, Spain

研究点 (2)

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