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临床试验/NCT07637890
NCT07637890已完成不适用

Designing a Multicomponent Intervention for Improving Frailty. A Pilot Study in the Basque Country

Biogipuzkoa Health Research Institute1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年12月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1

研究概览

简要总结

This pilot study tested whether a new program for older adults with frailty could realistically be carried out in primary health care. That is why the main objective of this study was to evaluate the viability and feasibility of the newly designed frailty intervention.

People over 65 were recruited in two health centers and invited to join a 3 month program combining group exercise, a medication review by a pharmacist, and nutrition workshops. The study also collected information on mobility, strength, nutrition, mood, cognition, and quality of life. Most measures were taken at the start and again four and eight months later.

The results will help refine the program and guide the design of a larger clinical trial.

详细描述

The study assessed the viability and feasibility of a frailty intervention in routine clinical practice through a prospective one-arm pilot conducted in two primary care centers in Donostia (Gipuzkoa, Basque Country, Spain). Participants were adults aged 65 or older, functionally independent (Barthel >90) and classified as frail (Short Physical Performance Battery <10), who received a 12-week physical exercise program, nutritional counseling, and a pharmacological review.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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
  • Barthel >90 points (independent)
  • Short Physical Performance Battery <10 points (frail)

排除标准

  • Having a terminal condition
  • Suffering from pathologies with a poor prognosis
  • Having difficulty in performing physical activities
  • Not being able to communicate fluently in Spanish
  • Presenting intellectual disabilities

研究组 & 干预措施

Intervention: physical exercise, polypharmacy review and nutritional care

Experimental

The arm is composed of people aged >65, independent (≥95 points) and frail (Short Physical Performance Battery <10 points). The entire arm group receives the multi-component intervention based on physical exercise, polypharmacy review and nutritional care.

干预措施: Multi-component intervention: physical exercise, polypharmacy review and nutritional care (Other)

结局指标

主要结局

未指定

次要结局

  • Change from Baseline in Cognitive Status at 4 and 8 months(From baseline to 8 months)

研究者

发起方
Biogipuzkoa Health Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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