Electrostimulation Program for Lung Transplant Recipients in the ICU

Study Overview
=================
Brief Summary
-----------------
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)

Detailed Description
-----------------
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. The aim of this study is assessment of muscle status in transplant recipients in lung transplant recipients after application of EMS therapy in the ICU.The sample is divided into two groups, a control group that will not receive EMS therapy and a control group that receive it.

Official Title
-----------------
Effect of an Electrostimulation Program in Lung Transplant Recipients During Their Stay in the Intensive Critical Care Unit. Experimental Study

Conditions
-----------------
Lung Transplantation

Intervention / Treatment
-----------------
* Device: EMS Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental lung transplant<br>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. | Device: EMS Program<br>* Lower limb electrostimulation therapy is scheduled for lung transplant patients. The therapy consists in the application of 2 daily 30-minute sessions that begin in the first 48 hours post-transplantation and are maintained daily until discharge from the hospital.<br>|
| No Intervention: Control lung transplant<br>Electro stimulation therapy will not be performed. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of muscle mass in the quadriceps | 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. | 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). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobility assessment according to ICU-Mobility scale (IMS) | Ability to move during ICU admission. IMS is a scale containing 10 items ranging from 0 (no mobility at all) to 10 (walks unaided), which some authors have categorized binary (< 4 passive/active mobilization in bed and ≥ 4 active mobilization out of bed). | Each day in the morning and afternoon, until discharge from ICU (up to 14 days). | 
| Leg strength according to Chair and Stand test | Leg strength assessment before transplantation and at discharge from ICU (up to 14 days), using Chair and Stand test | Up to 6 months prior to transplantation and at ICU discharge (up to 14 days) |