CYCLE Pilot: A Pilot Randomized Study of Early Cycle Ergometry Versus Routine Physiotherapy in Mechanically Ventilated Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 9
- 主要终点
- Patient accrual
研究概览
简要总结
Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need advanced life-support. Survivors of critical illness are very weak and disabled. Up to 1 in 4 have severe leg weakness impairing their quality of life for as long as 5 years after ICU discharge. In-bed cycling involves use of special equipment that attaches to a patient's hospital bed, allowing them gentle exercise while in the ICU.
Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to survive their ICU stay are eligible. Patients will randomly receive 30 minutes of in-bed cycling each day they are in the ICU or routine physiotherapy, both delivered by specially trained physiotherapists.
Outcomes: Feasibility: The investigators will study whether patients can cycle on most days of their ICU stay, whether patients and their families agree to be a part of the study, and whether investigators can systematically assess patients' strength.
Relevance: Effective methods of physiotherapy are needed for critically ill patients to minimize muscle weakness, speed recovery, and improve quality of life. This pilot randomized study is the second of several future larger studies about in-bed cycling in the ICU.
Our pilot work includes CYCLE Pilot and CYCLE Vanguard. CYCLE Pilot is an external pilot and enrolled 66 patients from 3/2015 to 6/2016. CYCLE Vanguard is an internal pilot and enrolled 47 patients from 11/2016 to 3/2018. CYCLE Vanguard patients will be analyzed in the main CYCLE RCT (NCT03471247).
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 admitted to a medical-surgical ICU within the 1st 4 days of mechanical ventilation (MV) and 1st 7 days of ICU, and
- •could ambulate independently before hospital admission.
排除标准
- •Acute condition impairing patients' ability to cycle (e.g., leg fracture),
- •proven or suspected neuromuscular weakness affecting the legs (e.g., stroke or Guillain-Barré syndrome),
- •unable to follow commands in English pre-ICU,
- •temporary pacemaker,
- •expected hospital mortality >90%,
- •unable to fit the bike, palliative goals of care, or persistent therapy exemptions in the 1st 4 days of MV (e.g., cardiorespiratory instability, active major bleeding)
研究组 & 干预措施
Early Cycling and routine physiotherapy
Patients will receive 30 minutes of in-bed cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay
干预措施: In-bed cycle ergometer (Restorative Therapies RT300 Supine) (Device)
Routine physiotherapy
Patients will receive routine physiotherapy per current institutional practice
干预措施: Routine physiotherapy (Other)
结局指标
主要结局
Patient accrual
时间窗: 2 years
次要结局
- Outcome measure ascertainment (% outcomes measured in hospital)(2 years)
- Muscle strength at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only), and hospital discharge(From study admission to approximately 5, 12, 15 and 30 days, on average, respectively)
- Cycling protocol violations (% cycling protocol violations)(2 years)
- Quadriceps strength at ICU and hospital discharge (Force measured in Kg and in Newtons on a continuous scale)(From study admission to approximately 12 and 30 days, on average, respectively)
- Blinded outcome measures at hospital discharge (% outcomes at hospital discharge measured by blinded outcome assessors)(2 years)
- Physical Function Test for ICU (PFIT) at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only) and hospital discharge(From study admission to approximately 5, 12, 15 and 30 days, on average, respectively)
- 2 minute walk test at ICU discharge, 3-days post-ICU (CYCLE Vanguard only), and hospital discharge(From study admission to approximately 12 and 30 days, on average, respectively)