CYCLE RCT: An International, Multi-centre, Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 360
- 试验地点
- 32
- 主要终点
- Physical Function Test for ICU-scored (PFIT-s)
研究概览
简要总结
Patients who survive critical illness usually experience long-lasting physical and psychological impairments, which are often debilitating. Rehabilitation interventions started in the ICU may reduce this morbidity. In-bed cycling, which uses a special bicycle that attaches to the hospital bed, allows critically ill patients who are mechanically ventilated (MV) to gently exercise their legs while in the ICU. The main goal of this study is to determine whether critically ill MV adults recover faster if they receive early in-bed cycling than if they do not. Another objective is to determine whether in-bed cycling is a cost-effective intervention. 360 patients admitted to the ICU and receiving MV will be enrolled in the study. Following informed consent, patients will be randomized to either (1) early in-bed cycling and routine physiotherapy or (2) routine physiotherapy alone. Patients' strength and physical function will be measured throughout the study. If early in-bed cycling during critical illness improves short-term physical and functional outcomes, it could accelerate recovery and reduce long-term disability in ICU survivors.
详细描述
Background: Survivors of critical illness have a long road of physical, cognitive, and psychological recovery. Although medical advances have reduced the mortality of critical illness, survival often comes with substantial long-term morbidity and societal cost. At 1-year follow-up, ~35% of intensive care unit (ICU) survivors had sub-normal 6-minute walk distance, and ~50% had not returned to work. Rehabilitation interventions started in the ICU may reduce this morbidity. In-bed cycling is a novel technology that may help critically ill, mechanically ventilated (MV) patients receive exercise very early to prevent or attenuate muscle weakness. Patients on MV typically receive prolonged bedrest and are often perceived as 'too sick' for physiotherapy (PT) interventions. However expert consensus and our previous multicentre pilot work suggest these interventions are safe. The CYCLE RCT will evaluate whether early in-bed cycling compared to usual PT interventions improves patient-reported outcomes.
Objectives:
- CYCLE RCT: To determine if early in-bed cycling and routine PT compared to routine PT alone in critically ill, mechanically ventilated adults improves the primary outcome of physical function at 3 days after ICU discharge and secondary outcomes of strength, physical function, frailty, psychological distress, quality of life, mortality, and healthcare utilization.
- Economic Evaluation: To determine the cost-effectiveness of cycling and routine PT compared to routine PT alone among critically ill, mechanically ventilated adults.
Design: 360-patient concealed open-label RCT with blinded outcome assessment
Population: Critically ill adults receiving MV in a medical-surgical ICU
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
- •Patient is ≥ 18 years of age
- •Patient is invasively mechanically ventilated ≤ 4 days
- •Expected additional 2 day ICU stay
- •Ability to ambulate independently (with or without gait aid) before their critical illness
- •ICU length of stay ≤ 7 days
排除标准
- •Pre-hospital inability to follow simple commands in local language at baseline
- •Acute conditions impairing ability to receive cycling
- •Severe cognitive impairment pre-ICU
- •Traumatic brain injury
- •Acute proven or suspected central or peripheral neuromuscular weakness affecting the legs (e.g., stroke, Guillian-Barre syndrome, spinal injury)
- •Temporary pacemaker (internal or external)
- •Expected hospital mortality ≥ 90%
- •Equipment unable to fit patient's body dimensions (elg., leg amputation, morbid obesity)
- •Palliative goals of care
- •Pregnancy (suspected or proven)
- •Specific surgical exclusion as stipulated by surgery or ICU team
- •Physician declines
- •Cycling exemption not resolved during first 4 days of mechanical ventilation
- •Patient already able to march on spot at time of screening
结局指标
主要结局
Physical Function Test for ICU-scored (PFIT-s)
时间窗: 3 days after ICU discharge
Patients complete 4 activities: arm and leg strength, ability to stand, and step cadence. Scores range from 0 to 10, with higher scores = better function.
次要结局
- 30 Second Sit to Stand(ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission)
- Muscle Strength(ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission)
- Length of stay(From hospital admission to ICU discharge (approximately 14 days) and hospital discharge (approximately 21 days))
- Patient-Reported Functional Scale-ICU (PRFS-ICU)(ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment)
- Clinical Frailty Scale(Baseline; hospital discharge, approximately 28 days after ICU admission)
- Two Minute Walk Test(ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission)
- Katz Activities of Daily Living (ADL) Scale(Baseline; ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission)
- Intensive Care Psychological Assessment Tool (IPAT)(After ICU awakening assessment, approximately 7 days after ICU admission)
- Mortality(From study admission to 3 months after enrollment)
- Hospital Discharge Location(Hospital discharge, approximately 28 days after ICU admission)
- Intervention and Healthcare Costs(From study admission to 3 months after enrollment)
- Physical Function Test for ICU-scored (PFIT-s)(ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; Hospital Discharge, approximately 28 days after ICU admission)
- Health-Related Quality of Life - EuroQol-5D-5L and Visual Analogue Scale(ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment)
- Hospital Anxiety and Depression Scale (HADS)(3 months after enrollment)
- Quality-Adjusted Life Years (QALYs)(3 months after enrollment)
- Duration of Mechanical Ventilation(From study admission to ICU discharge, approximately 10 days)
- Healthcare Utilization(From study admission to 3 months after enrollment)