Targeted Physical Function Exercises on Frailty and Falls Management in Pre-Frail Community-Dwelling Older Adults: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Level of Frailty status
研究概览
简要总结
The investigators will conduct a randomized controlled trial to assess the impact of targeted physical function exercises on frailty and falls in community-dwelling adults over 65 years of age. Participants will be randomized to an intervention and a control group to undergo an 18-month assessment.
The hypothesis of this study is to investigate the impact of targeted physical function exercises on managing frailty status and concerns about falling among pre-frail older adults. By implementing individualized intervention programs tailored to improve strength, balance, and mobility, the investigators aim to enhance physical function and reduce the risk of frailty-related adverse health outcomes. The investigators seek to empower pre-frail older adults to proactively manage their health, maintain independence, and improve their quality of life as they age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •participants aged 65 and over
- •classified as pre-frail according to SHARE-Frailty Instrument
- •independent of movement and activity
- •able to perform Mini-Mental Status Examination (MMSE) score ≥24
排除标准
- •severe contraindications for physical exercise
- •central nervous system impairments
- •inability to speak and understand Greek properly
- •a cognitive state that prevents understanding the researcher's instructions
结局指标
主要结局
Level of Frailty status
时间窗: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
SHARE Frailty Instrument will be used. Diagnostic criteria include involuntary loss of weight and muscle mass, exhaustion, low physical activity, slowness, and reduced grip strength. The presence of three or more criteria indicates frailty, while the presence of less than three pre-frailty
Concerns about Falling
时间窗: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
The Falls Efficacy Scale - International (FES-I), a 16-item questionnaire that assesses the participant's fall efficacy, will be used to measure the level of concern about falling during various social and physical activities. Every item has a four-point (1-4) score, summarizing a total score of 64 points. A 16-22 score indicates low concern about falling, and a 23-64 high concern.
次要结局
- Physical Performance(From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).)
- Functional Mobility(From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).)
- Functional Balance(From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).)
- Quality of Daily Living(From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).)
- Depression(From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).)
研究者
Konstantinos Giakoumidakis
Associate Professor
Hellenic Mediterranean University