Clinical trial NCT03788876: Neuromuscular Electrical Stimulation After Lung Transplantation
Official title: Neuromuscular Electrical Stimulation After Lung Transplantation: Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Transplantation
Electric Stimulation
Clinical Trial
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Femoral quadriceps muscle thickness
timeFrame: three weeks
measure: Muscle quadriceps muscle quality Evaluation of muscle quality through ultrasound images
timeFrame: three weeks
Secondary outcomes:
measure: Muscle Strength - Scale Medical Research Council (MRC)
timeFrame: three weeks
measure: Dynamometry
timeFrame: three weeks
measure: Sit and stand up
timeFrame: three weeks
measure: 30 meter walk test
timeFrame: three weeks
measure: Spirometry
timeFrame: three weeks
measure: Blood Markers
timeFrame: three weeks
measure: Hydric balance
timeFrame: three weeks
measure: length of stay in the ICU
timeFrame: three weeks
measure: Length of stay in invasive mechanical ventilation
timeFrame: three weeks
measure: Time of weaning from invasive mechanical ventilation
timeFrame: three weeks
measure: Survival Rate
timeFrame: three weeks
measure: Success of weaning from invasive mechanical ventilation
timeFrame: three weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: HCPA
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital of Clinics of Porto Alegre
name: Graciele Sbruzzi
role: PRINCIPAL_INVESTIGATOR
References: