A Randomized Control Trial of an Intervention to Reverse Frailty and Enhance Resilience Through Exercise and Education (REFEREE)
A Randomized Control Trial of a Primary Care Intervention to Reverse Frailty and Enhance Resilience Through Resistance Exercise and Dietary Protein Education (REFEREE) Among Community Dwelling Adults Aged 65 and Over
Resistance training done at home and protein supplementation may be the most effective and easiest to implement interventions to reverse frailty and build resilience. However, it is not common practice to offer and support such interventions in primary care.
This study provides an opportunity to assess the effectiveness of an optimised intervention with community-dwelling adults aged 65 and over, whose baseline clinical frailty score is not worse than mild (i.e. 5 or less), evaluate improvements in health outcomes and demonstrate how the intervention may be incorporated efficiently in clinical practice. The results are intended to encourage mainstream adoption of practical interventions to reverse clinical frailty and build resilience in primary care.
An intervention with ten recommended resistance exercises and dietary guidance on protein consumption has been derived from findings of our systematic review and meta-analysis and optimised through a patient and public involvement (PPI) process and feasibility study.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Dublin、爱尔兰
- Beechlawn Medical Centre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged 65 or older at baseline
- Rockwood clinical frailty scale score 4 or 5 (vulnerable or mildly frail)
- Able and willing to provide informed consent and to comply with the requirements of this study protocol
Exclusion Criteria:
- Rockwood clinical frailty scale score > 5
- End of life care
- Persons in residential care home
- Concurrent malignancy CKD stage 3 or 4
- Coded diagnosis of severe dementia as per GP or consultant geriatrician diagnosis or baseline Montreal Cognitive assessment (MoCA) score <= 10
- Persons unable to engage in discussion on frailty due to acute care needs or determined to be inappropriate by GP (e.g., needing transfer to ED or acutely unwell or disorders resulting in intolerance of the intervention)
- Subjects unable to provide written informed consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：控制
日常护理
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实验性的：Intervention
Resistance exercise and dietary protein guidance
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Home based exercise regime and dietary protein guidance
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Frailty status
大体时间：3 months
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Frailty status as measured by SHARE-frailty instrument measurement
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical frailty status
大体时间：3 months
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Clinical frailty status measured by Clinical Frailty Scale 1 to 9, 9 is worse
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3 months
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Sarcopenia/ muscle mass
大体时间：3 months
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Sarcopenia/ muscle mass measured by bioelectrical impedance
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3 months
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Ease of the intervention
大体时间：3 months
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Ease of the intervention measured on a five-point scale: 'very easy', 'somewhat easy', 'neither easy nor hard', 'somewhat hard', or 'very hard'
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3 months
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Subjective difference to general health
大体时间：3 months
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Difference to general health as a result of the exercises measured on a five-point scale: 'much better', 'slightly better', 'about the same', 'slightly worse' or 'much worse'
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3 months
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Bone mass
大体时间：3 months
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Bone mass measured by bioelectrical impedance
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3 months
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Body fat
大体时间：3 months
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measured by bioelectrical impedance
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3 months
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Biological age
大体时间：3 months
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measured by bioelectrical impedance
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3 months
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合作者和调查者
调查人员
- 研究主任：Marie Therese Cooney, PhD、University College Dublin
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Exercise and protein的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的