Clinical Trial, Electric Stimulation, Lung Transplantation
Conditions
Brief summary
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
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.
Interventions
OTHERNeuromuscular electrical stimulation
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.
OTHERConventional care
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.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Femoral quadriceps muscle thickness | three weeks | Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE). |
| Muscle quadriceps muscle quality Evaluation of muscle quality through ultrasound images | three weeks | Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sit and stand up | three weeks | 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. |
| 30 meter walk test | three weeks | Evaluates walking speed for six minutes |
| Spirometry | three weeks | Evaluates lung function |
| Blood Markers | three weeks | Evaluates markers of muscle injury. |
| Hydric balance | three weeks | Through patient records |
| Muscle Strength - Scale Medical Research Council (MRC) | three weeks | 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. |
| Length of stay in invasive mechanical ventilation | three weeks | Through patient records |
| Time of weaning from invasive mechanical ventilation | three weeks | Through patient records |
| Survival Rate | three weeks | Through patient records |
| Success of weaning from invasive mechanical ventilation | three weeks | Through patient records |
| length of stay in the ICU | three weeks | Through patient records |
| Dynamometry | three weeks | Dynamometry = handgrip test |
Countries
Brazil
Contacts
Primary ContactGraciele Sbruzzi
Outcome results
None listed