Neuromuscular Electrical Stimulation After Lung Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Neuromuscular Electrical Stimulation After Lung Transplantation: Randomized Clinical Trial.

Conditions
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Lung Transplantation, Electric Stimulation, Clinical Trial

Intervention / Treatment
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* Other: Neuromuscular electrical stimulation
* Other: Conventional care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Skin lesions at the electrode placement points.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neuromuscular electrical stimulation<br>The NMES training will be applied once a day (30 minutes of application per session with an increase of one minute every two days and reduction in the OFF time), until the discharge from the ICU. The patient will continue with the application also in the Hospitalization Units of HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre until discharge and the protocol of physiotherapy by the physiotherapists of HCPA twice a day that will consist in exercises for bronchial hygiene, exercises for pulmonary reexpansion and exercises of passive mobilization. | Other: Neuromuscular electrical stimulation<br>* The NMES training will be applied once a day (30 minutes of application per session with an increase of one minute every two days and reduction in the OFF time), until the discharge from the ICU. The patient will continue with the application also in the Hospitalization Units of HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre until discharge.<br>Other: Conventional care<br>* Physiotherapy protocol will be performed by HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre physiotherapists twice a day, which will consist of exercises for bronchial hygiene, exercises for pulmonary reexpansion, and passive mobilization exercises.<br>|
| Sham Comparator: Conventional care<br>The protocol of physiotherapy by the physiotherapists of HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre twice a day that will consist in exercises for bronchial hygiene, exercises for pulmonary reexpansion and exercises of passive mobilization. | Other: Conventional care<br>* Physiotherapy protocol will be performed by HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre physiotherapists twice a day, which will consist of exercises for bronchial hygiene, exercises for pulmonary reexpansion, and passive mobilization exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femoral quadriceps muscle thickness | Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE). | three weeks | 
| Muscle quadriceps muscle quality Evaluation of muscle quality through ultrasound images | Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE). | three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Strength - Scale Medical Research Council (MRC) | The MRC score is obtained by evaluating 12 muscle groups in the upper extremities (wrist extensors, elbow flexors, and shoulder abductors) and lower limbs (dorsal ankle flexors, knee extensors, and hip flexors). Each muscle group will be given a score between 0 (complete paralysis) and 5 (normal strength), and the total score can range from 0 to 60 points. | three weeks | 
| Dynamometry | Dynamometry = handgrip test | three weeks | 
| Sit and stand up | At the starting signal the subject will have to get up until standing and returning to a sitting position. The subject will be encouraged to perform 10 consecutive repetitions in the shortest possible time interval. | three weeks | 
| 30 meter walk test | Evaluates walking speed for six minutes | three weeks | 
| Spirometry | Evaluates lung function | three weeks | 
| Blood Markers | Evaluates markers of muscle injury. | three weeks | 
| Hydric balance | Through patient records | three weeks | 
| length of stay in the ICU | Through patient records | three weeks | 
| Length of stay in invasive mechanical ventilation | Through patient records | three weeks | 
| Time of weaning from invasive mechanical ventilation | Through patient records | three weeks | 
| Survival Rate | Through patient records | three weeks | 
| Success of weaning from invasive mechanical ventilation | Through patient records | three weeks |