Rehabilitating Muscle After Intensive Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 4
- 主要终点
- The change in the distance walked by patients in 6 minutes (6 minute walk test) between recruitment to the study and 3 months post intensive care discharge
研究概览
简要总结
The study will examine the effect of amino acid supplements and enhanced physiotherapy on physical recovery following critical illness in intensive care.
详细描述
Critically ill patients aged 45 years and over will be recruited during recovery after intensive care. Using a randomised controlled, blind at follow-up design the study will examine whether the combination of an amino acid supplement and an enhanced physiotherapy programme improve the rehabilitation of muscle following intensive care better than a self-guided rehabilitation programme alone or with either an amino acid supplement or the enhanced physiotherapy programme. The Primary efficacy outcome will be the improvement in six minute walking test measured at 3 months post intensive care discharge. Secondary efficacy parameters will be insulin resistance, health related quality of life and muscle mass using DEXA scanning at 3 months and 1 year post intensive care discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •45 years of age and over with an intensive care stay of five days or more
排除标准
- •Physically not capable of engaging with the practical requirements of the study
研究组 & 干预措施
ICU Recovery Manual & placebo supplement
Patients will receive the standard self-directed rehabilitation package and a placebo nutritional supplement
干预措施: Intensive Care Unit (ICU) Recovery Manual (Other)
ICU Recovery Manual & placebo supplement
Patients will receive the standard self-directed rehabilitation package and a placebo nutritional supplement
干预措施: Placebo nutritional supplement (Dietary Supplement)
ICU recovery manual & amino acid (AA) supplement
Patients will receive the standard self-directed rehabilitation package with the essential amino acid supplement
干预措施: Amino acid supplement (Dietary Supplement)
PEPSE & placebo supplement
Patients will receive the standard self-directed rehabilitation package plus PEPSE and the placebo nutritional supplement
干预措施: Intensive Care Unit (ICU) Recovery Manual (Other)
ICU recovery manual & amino acid (AA) supplement
Patients will receive the standard self-directed rehabilitation package with the essential amino acid supplement
干预措施: Intensive Care Unit (ICU) Recovery Manual (Other)
PEPSE & placebo supplement
Patients will receive the standard self-directed rehabilitation package plus PEPSE and the placebo nutritional supplement
干预措施: PEPSE (Other)
PEPSE & placebo supplement
Patients will receive the standard self-directed rehabilitation package plus PEPSE and the placebo nutritional supplement
干预措施: Placebo nutritional supplement (Dietary Supplement)
PEPSE & AA supplement
Patients will receive the standard self-directed rehabilitation package plus PEPSE and the essential amino acid nutritional supplement
干预措施: Amino acid supplement (Dietary Supplement)
PEPSE & AA supplement
Patients will receive the standard self-directed rehabilitation package plus PEPSE and the essential amino acid nutritional supplement
干预措施: PEPSE (Other)
PEPSE & AA supplement
Patients will receive the standard self-directed rehabilitation package plus PEPSE and the essential amino acid nutritional supplement
干预措施: Intensive Care Unit (ICU) Recovery Manual (Other)
结局指标
主要结局
The change in the distance walked by patients in 6 minutes (6 minute walk test) between recruitment to the study and 3 months post intensive care discharge
时间窗: 3 months
次要结局
- Increase in muscle mass and bone density assessed using dual energy x-ray absorptiometry (DEXA) scanning between recruitment to the study and the 1 year follow-up point(1 year)
- Improvement in insulin resistance between recruitment to the study and the 1 year follow-up point(1 year)
- Improvement in patients perception of their health related quality of life between recruitment to the study and the 1 year follow-up point(1 year)