EMPRESS: A Feasibility Study of Early Mobilisation Programmes in Critical Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Physical Function ICU Test-scored
研究概览
简要总结
The objective of this study is to determine the feasibility of delivering a very early mobility rehabilitation program in Intensive Care Units (ICU), within the context of a randomised controlled trial (RCT). This will inform the design of a future RCT investigating very early ICU rehabilitation in the UK National Health Service.
详细描述
Early ICU-based physical rehabilitation may benefit patients with acute severe respiratory failure by attenuating the development of severe and persistent weakness and impaired physical function seen in these patients.
Muscle wasting occurs early (within 12 hours) and progresses rapidly after ICU admission. Patients may suffer from consequent physical impairment for months or years following their discharge.
ICU based rehabilitation has the potential to improve physical function outcomes, through mitigating muscle wasting.
The investigators have successfully introduced a very early ICU mobility program in their institution, which results in increased ventilator free days and reduced length of ICU stay.
The primary aim is to investigate whether this method will work in other ICUs. EMPRESS will test the feasibility of running this intervention as an RCT. The results and a concurrent process evaluation will inform the design of a future, multi-centre randomised controlled trial.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessment at ICU discharge, hospital discharge and 3 month follow-up will be undertaken by an assessor, blinded to study group allocation.
入排标准
- 年龄范围
- 42 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute/unplanned medical admissions to the ICU.
- •> 42 years old.
- •Functionally independent prior to ICU admission (Barthel >80).
- •In hospital for <5 days prior to intubation and ventilation.
- •Intubated and ventilated for <72 hrs.
- •Expected to remain ventilated for a further 48 hours.
排除标准
- •In hospital for 5 days or more prior to ITU admission.
- •Patients with acute brain or spinal cord injury.
- •Known or suspected neurological / muscular impairment.
- •Condition limiting use of cycle ergometer e.g. lower limb fracture / amputation.
- •Not expected to survive >48hrs.
- •Persistent therapy exemptions in first 3 days of mechanical ventilation.
- •Body habitus such as unable to use cycle ergometer.
- •Consultant clinician view that patient not suitable or not expected to survive admission.
结局指标
主要结局
Physical Function ICU Test-scored
时间窗: Up to 28 days
This is a reliable and valid 4 item scale ( arm strength, leg strength, ability to stand and step cadence),with a score range of 0-10 and is responsive to change and predictive of key outcomes.
次要结局
- Medical Research Council Manual Muscle Test Sum Score ( MRC-ss)(Up to 28 days)
- Hand held dynamometry (HHD)(Up to 12 weeks)
- Chelsea Critical Care Physical Assessment tool (CPAX)(Up to 28 days)
- ICU Mobility Scale(Up to 28 days)
- Timed up and go(Up to 6 months)
- Clinical Frailty Score(Up to 6 months)
- Barthel Index for Activities of Daily Living(Up to 6 months)
- Six minute walk test(Up to 6 months)
- The Hospital Anxiety and Depression Scale - HADS(6 months)
- WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)(6 months)
- EQ-5D-5L(6 months)