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Neuromuscular Electrical Stimulation After Lung Transplantation

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ClinicalTrials.gov Identifier: NCT03788876
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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).

Condition or disease Intervention/treatment Phase
Lung Transplantation Electric Stimulation Clinical Trial Other: Neuromuscular electrical stimulation Other: Conventional care Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuromuscular Electrical Stimulation After Lung Transplantation: Randomized Clinical Trial.
Actual Study Start Date : May 3, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


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 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 until discharge.

Other: Conventional care
Physiotherapy protocol will be performed by HCPA 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 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 physiotherapists twice a day, which will consist of exercises for bronchial hygiene, exercises for pulmonary reexpansion, and passive mobilization exercises.




Primary Outcome Measures :
  1. Femoral quadriceps muscle thickness [ Time Frame: Two weeks ]
    Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE).

  2. Muscle quadriceps muscle quality Evaluation of muscle quality through ultrasound images [ Time Frame: Two weeks ]
    Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE).


Secondary Outcome Measures :
  1. Muscle Strength - Scale Medical Research Council (MRC) [ Time Frame: 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.

  2. Dynamometry [ Time Frame: three weeks ]
    Dynamometry = knee extension

  3. Sit and stand up to 30 seconds [ Time Frame: three weeks ]
    Evaluate the maximum number of times you can stand and sit in 30 seconds.

  4. 30 meter walk test [ Time Frame: three weeks ]
    Evaluates walking speed for six minutes

  5. Spirometry [ Time Frame: three weeks ]
    Evaluates lung function

  6. Blood Markers [ Time Frame: three weeks ]
    Evaluates markers of muscle injury.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bilateral and Unilateral lung transplant;
  • Up to 48 hours for stable patients;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788876


Contacts
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Contact: Graciele Sbruzzi +555133085857 graciele.sbruzzi@ufrgs.br

Locations
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Brazil
HCPA Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90.035-903
Contact: Graciele Sbruzzi, doctor    +55 51 3359-7334 ext (51) 3359-7334    gsbruzzi@hcpa.edu.br   
Contact: Luma Zanatta de Oliveira, graduate    +55 51 998473359    lumazanatta@hotmail.com   
Irmandade da Santa Casa de Misericórdia de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-072
Contact: Rodrigo Della Méa Plentz, Doctor       roplentz@yahoo.com.br   
Contact: Isadora Rebolho Sisto, Graduate       isadora_sisto@hotmail.com   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Graciele Sbruzzi Hospital of Clinics of Porto Alegre

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03788876     History of Changes
Other Study ID Numbers: 20180497
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No