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临床试验/NCT05249504
NCT05249504尚未招募不适用

Efectividad de la intervención AMICOPE Para Mejorar y/o Mantener la Salud Autopercibida y la Capacidad intrínseca en Personas Mayores: un Ensayo clínico Aleatorizado (EFICIS)

Fundacio Salut i Envelliment UAB0 个研究点目标入组 212 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
212
主要终点
Self-perceived health

研究概览

简要总结

In their day to day, persons do from simple to more or less complicated tasks and activities (ie: stand from a chair, open a door, shopping, read, drive, play chess, remind an appointment...). Such ability to do things is called capacity. Intrinsic capacity is the combination of all the physical and mental capacities that a person has, and reach its maximum in the early adulthood and then declines as the person ages. Each kind of capacity declines at her own speed (which may be faster or slower according to each person lifestyle), and once drops below a threshold may lead to a reduction in quality of life and loss of autonomy.

Nevertheless there are some actions that may be effective to prevent or slow such decline. To do so the investigators have design an intervention that combines several things of different nature (what is know as a complex intervention) called AMICOPE. The AMICOPE intervention is performed in the community or in primary care centers through 12 weekly group sessions of 2 h 30 min which combine structured and adapted physical activity, group dynamics to promote social support and address loneliness, social isolation and depressive symptoms, and dietary advice.

Our study is addressed to persons over 70 with light problems in mobility, nutrition or mood state.

The purpose of this study is to assess if the AMICOPE intervention is better than the standard advice to follow healthy lifestyles to improve or maintain self-perceived health, mobility, nutritional status an psychological wellbeing.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Self-perceived health

时间窗: Baseline, after the intervention (average 16 weeks)

Change in self-perceived health status according to the Euroqol Visual Analogue Scale, where participants scores from 0 (worse state) to 100 (better state) their current perceived health

次要结局

  • Autonomy in daily life.(Baseline, after the intervention (average 16 weeks))
  • Health related quality of life.(Baseline, after the intervention (average 16 weeks))
  • Depressive symptoms(Baseline, after the intervention (average 16 weeks))
  • Physical activity.(Baseline, after the intervention (average 16 weeks))
  • Functional status(Baseline, after the intervention (average 16 weeks))
  • Nutritional status(Baseline, after the intervention (average 16 weeks))
  • Social support and risk of isolation(Baseline, after the intervention (average 16 weeks))
  • Loneliness(Baseline, after the intervention (average 16 weeks))

研究者

申办方类型
Other
责任方
Sponsor

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