Neuromuscular Electrical Stimulation After Lung Transplantation

Lung Transplantation Clinical Trial

Official title:

Neuromuscular Electrical Stimulation After Lung Transplantation: Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03788876
• Other study ID #: 20180497
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: June 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Graciele Sbruzzi
• Phone: +555133085857
• Email: graciele.sbruzzi[@]ufrgs.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Trial
• Electric Stimulation
• Lung Transplantation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	HCPA	Porto Alegre	Rio Grande Do Sul
Brazil	Irmandade da Santa Casa de Misericórdia de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Dynamometry	Dynamometry = handgrip test	three weeks
Secondary	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
Secondary	30 meter walk test	Evaluates walking speed for six minutes	three weeks
Secondary	Spirometry	Evaluates lung function	three weeks
Secondary	Blood Markers	Evaluates markers of muscle injury.	three weeks
Secondary	Hydric balance	Through patient records	three weeks
Secondary	length of stay in the ICU	Through patient records	three weeks
Secondary	Length of stay in invasive mechanical ventilation	Through patient records	three weeks
Secondary	Time of weaning from invasive mechanical ventilation	Through patient records	three weeks
Secondary	Survival Rate	Through patient records	three weeks
Secondary	Success of weaning from invasive mechanical ventilation	Through patient records	three weeks