Early Cycle Ergometry for Critically-Ill Liver Failure Patients in a Transplant Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Functional Status Score for the Intensive Care Unit (FSS-ICU)
研究概览
简要总结
Critically-ill patients with liver disease are at high risk of developing sarcopenia and intensive care unit (ICU)-acquired weakness, which are associated with mortality and other poor outcomes. Early physical rehabilitation has shown benefit in ICU settings, but has not been studied in ICU patients with acute and chronic liver failure. Cycle ergometry, or stationary cycling in passive and active modes, may be especially beneficial to such patients due to their high prevalence of severe physical deconditioning and variable mentation. The aim of this study is to examine the feasibility, safety, and benefit of cycle ergometry over standard physical and occupational therapy (PT/OT) in critically-ill patients who have acute or chronic liver disease.
详细描述
A single-blinded randomized controlled trial will be conducted in a transplant intensive care unit (TICU). Eligible adult patients will be enrolled within 72 hrs after TICU admission and randomly allocated to either (1) standard PT/OT care, or (2) PT/OT care and cycle ergometry sessions with trained PT/OT therapists or technicians. The outcome measures, tests of strength and function, will be assessed at baseline, every 14 days, and upon TICU discharge by a blinded PT/OT therapist.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 ≥ years with acute or chronic liver disease admitted to Transplant Intensive Care Unit (TICU), or admitted to TICU following a liver or liver-kidney transplant
- •Expected to remain in ICU for ≥ 5 days
- •Spoken English fluency
排除标准
- •Known primary systemic neuromuscular disease or intracranial process causing increased intracranial pressure
- •Lower extremity amputation
- •Anticipated death or palliative withdrawal of life support within 5 days
- •Cycle ergometer weight limit (135 kg or 297.6 lbs per manufacturer)
研究组 & 干预措施
Cycle Ergometry + Standard PT/OT
The study intervention will include the same standard PT/OT procedures as the control arm (Standard PT/OT alone) with the addition of the Motomed Letto 2 lower extremity cycle ergometry sessions.
干预措施: Cycle ergometry (Device)
Standard PT/OT alone
The control arm will involve standard PT/OT procedures that patients in the transplant intensive care unit receive routinely, with frequency to be determined by a physical and/or occupational therapist, and may include but are not limited to the following:
Passive and active upper and lower extremity strength exercises, while in bed, sitting upright, and standing; stretching various muscle groups while supine in bed, sitting upright, and standing; in-bed mobility training including rolling and boosting; transfer training with and without an assistive device; gait training with and without an assistive device; balance exercises while sitting and standing; activities of daily living while sitting and standing; cognitive retraining
结局指标
主要结局
Functional Status Score for the Intensive Care Unit (FSS-ICU)
时间窗: Through study completion, average of 1 year
Standardized assessment tool for functional status in ICU patients. Score ranges from 0 (unable to perform) to 35 (highest function).
次要结局
- Number of participants who experience ICU readmission(Through study completion, average of 1 year)
- Number of participants who experience an adverse event during therapy(Through study completion, average of 1 year)
- ICU length of stay(Through study completion, average of 1 year)
- Duration of mechanical ventilation(Through study completion, average of 1 year)