Neuromuscular Electrical Stimulation After Lung Transplantation

NCT03788876 | Unknown

• 1 other identifier: 20180497
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Transplantation; Electric Stimulation; Clinical Trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Muscle Strength - Scale Medical Research Council (MRC)

  three weeks

• Dynamometry

  three weeks

• Sit and stand up

  three weeks

• 30 meter walk test

  three weeks

• Spirometry

  three weeks

Study Arms (2)

Neuromuscular electrical stimulation

ACTIVE COMPARATOR

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; Other: Conventional care

Conventional care

SHAM COMPARATOR

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

Interventions

Neuromuscular electrical stimulation OTHER

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.

Neuromuscular electrical stimulation

Conventional care OTHER

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.

Conventional care; Neuromuscular electrical stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Skin lesions at the electrode placement points.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (2)

HCPA

Porto Alegre, Rio Grande do Sul, 90.035-903, Brazil

RECRUITING

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-072, Brazil

RECRUITING

Study Officials

• Graciele Sbruzzi

  Hospital of Clinics of Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Graciele Sbruzzi

CONTACT

+555133085857; graciele.sbruzzi@ufrgs.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 28, 2018
• Study Start: May 3, 2019
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)