Neuromuscular Electrical Stimulation After Lung Transplantation

Neuromuscular Electrical Stimulation After Lung Transplantation: Randomized Clinical Trial.

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.

Study Overview

• Status: Unknown
• Conditions: Lung Transplantation; Clinical Trial; Electric Stimulation
• Intervention / Treatment: Other: Neuromuscular electrical stimulation; Other: Conventional care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90.035-903
      • Recruiting
      • HCPA
      • Contact: Graciele Sbruzzi, doctor; Phone Number: (51) 3359-7334 +55 51 3359-7334; Email: gsbruzzi@hcpa.edu.br
      • Contact: Luma Zanatta de Oliveira, graduate; Phone Number: +55 51 998473359; Email: lumazanatta@hotmail.com
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-072
      • Recruiting
      • Irmandade da Santa Casa de Misericordia de Porto Alegre
      • Contact: Rodrigo Della Méa Plentz, Doctor; Email: roplentz@yahoo.com.br
      • Contact: Isadora Rebolho Sisto, Graduate; Email: isadora_sisto@hotmail.com
      • Sub-Investigator: José de Jesus Peixoto Camargo, Doctor
      • Sub-Investigator: Sadi Marcelo Schio, Doctor
      • Sub-Investigator: Juliessa Florian, Doctor
      • Sub-Investigator: Isadora Rebolho Sisto, Graduate
      • Principal Investigator: Rodrigo Della Méa Plentz, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Neuromuscular 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 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; 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.; Other: Conventional 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.
Sham Comparator: Conventional care; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Graciele Sbruzzi, Hospital of Clinics of Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: December 27, 2018
• First Posted (Actual): December 28, 2018

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 20180497

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No