Neuromuscular Electrical Stimulation After Lung Transplantation: Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Muscle quadriceps muscle quality Evaluation of muscle quality through ultrasound images
研究概览
简要总结
Pulmonary transplantation aims to increase patient survival and quality of life in relation to functional aspects. It is observed that the decrease in muscle mass and pulmonary changes are some complications that can be found in the post-transplant patient due to immobility. Thus, Neuromuscular Electrical Stimulation (NMES) rehabilitation is of paramount importance for the recovery of the individual, both in the functional aspects, and in the minimization in the time of hospitalization.The objective of this study was to evaluate the effects of NMES on the thickness and strength of the quadriceps femoris muscle, pulmonary function, endothelial function, functional capacity, muscle biochemical markers, arterial blood gas analysis and water balance of patients after lung transplantation through a randomized clinical trial. Patients will be randomized into two groups: EENM group: will receive the application of NMES associated with physiotherapy and control group: who will receive only the physiotherapy protocol of the Hospital of Clinics of Porto Alegre (HCPA) and Irmandade da Santa Casa de Misericórdia de Porto Alegre.
详细描述
Pulmonary transplantation aims to increase patient survival and quality of life in relation to functional aspects. It is observed that the decrease in muscle mass and pulmonary changes are some complications that can be found in the post-transplant patient due to immobility. Thus, NMES rehabilitation is of paramount importance for the recovery of the individual, both in the functional aspects, and in the minimization in the time of hospitalization.The objective of this study was to evaluate the effects of NMES on the thickness and strength of the quadriceps femoris muscle, pulmonary function, endothelial function, functional capacity, muscle biochemical markers, arterial blood gas analysis and water balance of patients after lung transplantation through a randomized clinical trial. Patients will be randomized into two groups: EENM group: will receive the application of NMES associated with physiotherapy and control group: who will receive only the physiotherapy protocol of the HCPA. The NMES training will be applied once a day (30 minutes of application per session, increasing one minute every two days and reducing the OFF time), until the discharge of the Intensive Care Unit (ICU). The patient will continue with the application also in the Hospitalization Units of the HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre until the hospital discharge. The following outcomes will be evaluated: thickness and strength of the quadriceps muscle, pulmonary function, endothelial function, functional capacity, mobility, muscle biochemical markers, arterial blood gas analysis, water balance and length of stay in the ICU, time and success of weaning from invasive mechanical ventilation and survival rate through medical records analysis.
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
- Double (Investigator, 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
- •Bilateral and Unilateral lung transplant;
- •After extubation of invasive mechanical ventilation up to 48 hours for stable patients;
- •After extubation of invasive mechanical ventilation up to 72 hours for those who are present in the instability;
- •Chronic obstructive pulmonary disease
- •Cystic fibrosis
- •Fibrotic pulmonary idiopathic
排除标准
- •Skin lesions at the electrode placement points.
结局指标
主要结局
Muscle quadriceps muscle quality Evaluation of muscle quality through ultrasound images
时间窗: three weeks
Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE).
Femoral quadriceps muscle thickness
时间窗: three weeks
Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE).
次要结局
- Dynamometry(three weeks)
- Hydric balance(three weeks)
- Muscle Strength - Scale Medical Research Council (MRC)(three weeks)
- 30 meter walk test(three weeks)
- Spirometry(three weeks)
- Blood Markers(three weeks)
- Time of weaning from invasive mechanical ventilation(three weeks)
- Success of weaning from invasive mechanical ventilation(three weeks)
- Sit and stand up(three weeks)
- Length of stay in invasive mechanical ventilation(three weeks)
- Survival Rate(three weeks)
- length of stay in the ICU(three weeks)