Early Rehabilitation Using Functional Electrical Stimulation Assisted Supine Cycling Effect on Muscle Mass, Strength, Biomarkers, and Functional Outcomes as Compared With Conventional Exercise and Early Mobilization Alone in Critically Ill Patients in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Percent change of rectus femoris cross-sectional area
研究概览
简要总结
Critically ill patients in the intensive care unit are known to lose muscle mass and function at a rapid rate. Currently, there is a global recognition and shift in the ICU culture to reduce sedation and encourage exercise and mobilization early during the ICU stay. Functional stimulation assisted supine cycling can be applied to patients in the bed and does not require patient participation. This study seeks to evaluate the effect of conventional exercise and early mobilization in combination with functional stimulation assisted supine cycling applied early during the ICU on muscle mass, strength, and physical function, as well as patient-reported disability as compared to conventional exercise and early mobilization alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •≥ 18 years of age
- •Admitted to the ICU with a predicted ICU length of stay ≥ 4 days
- •Expected to survive the ICU stay
- •Expected to receive mechanical ventilation > 48 hours
- •Able to perform physical outcome measures pre-morbidly (with or without an assisted device)
排除标准
- •Proven or suspected neuromuscular weakness affecting the legs (eg- stroke or Guillain-Barré syndrome)
- •Lower limb amputation(s)
- •Assessed by medical staff as approaching imminent death or withdrawal of medical treatment within 36 hours
- •Pregnancy
- •Body mass index > 40
- •Presence of external fixator or superficial metal in lower limb
- •Open wounds or skin abrasions at electrode application points
- •Presence of pacemaker or implanted defibrillator
- •Transferred from another ICU after >48 hours of consecutive mechanical ventilation
- •Lower limb malignancy
- •Pre-existing intellectual disability or cognitive impairment limiting the ability to accurately follow instructions
- •Body habitus unable to fit the bike
- •Palliative goals of care
- •Unable to participate in FESC within 48 hours of ICU admission due to logistic reasons or due to failure in daily screening for participation
结局指标
主要结局
Percent change of rectus femoris cross-sectional area
时间窗: Baseline (within 24 hours of enrollment), weekly during ICU admission (up to a maximum of 28 days), at ICU discharge (an average of 11 days after admission), and at hospital discharge (an average of 15 days after admission)
Ultrasound measurements will be done with patients in supine position with their leg in passive extension and neutral rotation.
次要结局
- Quality of life(At hospital discharge (an average of 15 days after admission), and 90 days, 6 months, and 1 year post ICU discharge)
- Duration of mechanical ventilation(Through discontinuation of mechanical ventilation, an average of 10 days)
- Cognition(At hospital discharge (an average of 15 days after admission))
- Hospital length of stay(Through hospital discharge, an average of 15 days)
- ICU length of stay(Through ICU discharge, an average of 11 days)
- Diaphragm muscle thickness(Baseline (within 24 hours of enrollment), weekly in the ICU (up to a maximum of 28 days), at ICU discharge (an average of 11 days after admission), and at hospital discharge (an average of 15 days after admission))
- Muscle strength(Baseline (within 24 hours of enrollment), weekly in the ICU (up to a maximum of 28 days), at ICU and hospital discharge (an average of 11 and 15 days after admission, respectively), and at 90 days, 6 months, and 1 year post ICU discharge)
- Physical function(Baseline (within 24 hours of enrollment), weekly during ICU admission (up to a maximum of 28 days), at ICU discharge (an average of 11 days after admission), and at hospital discharge (an average of 15 days after admission))