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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 2
- 主要终点
- Frailty status
研究概览
简要总结
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Frailty status
时间窗: 3 months
Frailty status as measured by SHARE-frailty instrument measurement
次要结局
- Sarcopenia/ muscle mass(3 months)
- Clinical frailty status(3 months)
- Ease of the intervention(3 months)
- Bone mass(3 months)
- Subjective difference to general health(3 months)
- Body fat(3 months)
- Biological age(3 months)
研究者
John Travers
Doctor
University College Dublin