Effect of an Electrostimulation Program in Lung Transplant Recipients During Their Stay in the Intensive Critical Care Unit. Experimental Study
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Variation of muscle mass in the quadriceps
研究概览
简要总结
This study aims to evaluate rectus femoris muscle mass in lung transplant recipients and the effect of a training program during ICU admission based on the use of electrical muscle stimulation (EMS)
详细描述
Lung transplantation is so far the only viable therapy for those individuals with a life-threatening chronic respiratory individuals with a chronic respiratory problem that compromises their life in a period of less than two years and the therapeutic options have been exhausted.
The investigators are dealing with individuals with a prolonged disease process, characterized mainly by the reduction of their respiratory capacities, which has a great impact on the basic activities of daily living.
Pulmonary involvement conditions the mobility of the individual, limiting physical activity and leading to episodes of dyspnea.
The aerobic capacity of the patient is very impaired before the transplant, although after the transplant, it continues in levels below normal for their age . This, resulting in episodes of dyspnea impacts on the extraction and utilization of muscular oxygen , which reduces mobility periods.
Limitations in physical activity and even mobility prior to physical activity and even mobility limitations prior to transplantation lead these individuals to marked muscular deterioration, which has an impact on both the general physical and psychological levels.
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
- None
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
- •Admitted to the lung transplant list according to the criteria of the Health System.
- •Those who attend the rehabilitation consultation of the hospital under study to undergo treatment prior to transplantation.
- •They must receive the graft at the hospital under study and be admitted to the resuscitation unit at the same center for post-surgical follow-up.
排除标准
- •Those who are rejected from the transplant list or deceased before the implant is performed.
- •Lack of follow-up by the rehabilitation consultation.
- •Are receiving treatment with muscle relaxants after admission to the ICU.
- •Present skin alterations incompatible with EMS.
- •Contraindications to perform the transplant proposed according to the criteria of the Health System.
研究组 & 干预措施
Experimental lung transplant
The training time will be 30 minutes in the morning and 30 minutes in the afternoon with a total daily work time of 60 minutes. The frequency of work will be different in each session, seeking in the morning routine a vascularization and improvement of muscle trophism and in the afternoon an aerobic endurance, activation of the working capacity of the tonic muscles to improve the stabilizing muscles and postural fitness.
干预措施: EMS Program (Device)
Control lung transplant
Electro stimulation therapy will not be performed.
结局指标
主要结局
Variation of muscle mass in the quadriceps
时间窗: Up to 6 months prior to transplantation, within 24 hours of admission and every seven days and/or until discharge from the ICU (up to 14 days).
The quadriceps muscle mass of the lung transplant recipient will be measured prior to transplantation and will be monitored in the first 24 hours post-transplant and every 7 days from admission until hospital discharge.
次要结局
- Mobility assessment according to ICU-Mobility scale (IMS)(Each day in the morning and afternoon, until discharge from ICU (up to 14 days).)
- Leg strength according to Chair and Stand test(Up to 6 months prior to transplantation and at ICU discharge (up to 14 days))