<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03788876</url>
  </required_header>
  <id_info>
    <org_study_id>20180497</org_study_id>
    <nct_id>NCT03788876</nct_id>
  </id_info>
  <brief_title>Neuromuscular Electrical Stimulation After Lung Transplantation</brief_title>
  <official_title>Neuromuscular Electrical Stimulation After Lung Transplantation: Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pulmonary transplantation aims to increase patient survival and quality of life in relation&#xD;
      to functional aspects. It is observed that the decrease in muscle mass and pulmonary changes&#xD;
      are some complications that can be found in the post-transplant patient due to immobility.&#xD;
      Thus, Neuromuscular Electrical Stimulation (NMES) rehabilitation is of paramount importance&#xD;
      for the recovery of the individual, both in the functional aspects, and in the minimization&#xD;
      in the time of hospitalization.The objective of this study was to evaluate the effects of&#xD;
      NMES on the thickness and strength of the quadriceps femoris muscle, pulmonary function,&#xD;
      endothelial function, functional capacity, muscle biochemical markers, arterial blood gas&#xD;
      analysis and water balance of patients after lung transplantation through a randomized&#xD;
      clinical trial. Patients will be randomized into two groups: EENM group: will receive the&#xD;
      application of NMES associated with physiotherapy and control group: who will receive only&#xD;
      the physiotherapy protocol of the Hospital of Clinics of Porto Alegre (HCPA) and Irmandade da&#xD;
      Santa Casa de Misericórdia de Porto Alegre.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pulmonary transplantation aims to increase patient survival and quality of life in relation&#xD;
      to functional aspects. It is observed that the decrease in muscle mass and pulmonary changes&#xD;
      are some complications that can be found in the post-transplant patient due to immobility.&#xD;
      Thus, NMES rehabilitation is of paramount importance for the recovery of the individual, both&#xD;
      in the functional aspects, and in the minimization in the time of hospitalization.The&#xD;
      objective of this study was to evaluate the effects of NMES on the thickness and strength of&#xD;
      the quadriceps femoris muscle, pulmonary function, endothelial function, functional capacity,&#xD;
      muscle biochemical markers, arterial blood gas analysis and water balance of patients after&#xD;
      lung transplantation through a randomized clinical trial. Patients will be randomized into&#xD;
      two groups: EENM group: will receive the application of NMES associated with physiotherapy&#xD;
      and control group: who will receive only the physiotherapy protocol of the HCPA. The NMES&#xD;
      training will be applied once a day (30 minutes of application per session, increasing one&#xD;
      minute every two days and reducing the OFF time), until the discharge of the Intensive Care&#xD;
      Unit (ICU). The patient will continue with the application also in the Hospitalization Units&#xD;
      of the HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre until the hospital&#xD;
      discharge. The following outcomes will be evaluated: thickness and strength of the quadriceps&#xD;
      muscle, pulmonary function, endothelial function, functional capacity, mobility, muscle&#xD;
      biochemical markers, arterial blood gas analysis, water balance and length of stay in the&#xD;
      ICU, time and success of weaning from invasive mechanical ventilation and survival rate&#xD;
      through medical records analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 3, 2019</start_date>
  <completion_date type="Anticipated">November 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Femoral quadriceps muscle thickness</measure>
    <time_frame>three weeks</time_frame>
    <description>Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle quadriceps muscle quality Evaluation of muscle quality through ultrasound images</measure>
    <time_frame>three weeks</time_frame>
    <description>Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle Strength - Scale Medical Research Council (MRC)</measure>
    <time_frame>three weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamometry</measure>
    <time_frame>three weeks</time_frame>
    <description>Dynamometry = handgrip test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sit and stand up</measure>
    <time_frame>three weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 meter walk test</measure>
    <time_frame>three weeks</time_frame>
    <description>Evaluates walking speed for six minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry</measure>
    <time_frame>three weeks</time_frame>
    <description>Evaluates lung function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Markers</measure>
    <time_frame>three weeks</time_frame>
    <description>Evaluates markers of muscle injury.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hydric balance</measure>
    <time_frame>three weeks</time_frame>
    <description>Through patient records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of stay in the ICU</measure>
    <time_frame>three weeks</time_frame>
    <description>Through patient records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in invasive mechanical ventilation</measure>
    <time_frame>three weeks</time_frame>
    <description>Through patient records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of weaning from invasive mechanical ventilation</measure>
    <time_frame>three weeks</time_frame>
    <description>Through patient records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival Rate</measure>
    <time_frame>three weeks</time_frame>
    <description>Through patient records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success of weaning from invasive mechanical ventilation</measure>
    <time_frame>three weeks</time_frame>
    <description>Through patient records</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Lung Transplantation</condition>
  <condition>Electric Stimulation</condition>
  <condition>Clinical Trial</condition>
  <arm_group>
    <arm_group_label>Neuromuscular electrical stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional care</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neuromuscular electrical stimulation</intervention_name>
    <description>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.</description>
    <arm_group_label>Neuromuscular electrical stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional care</intervention_name>
    <description>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.</description>
    <arm_group_label>Conventional care</arm_group_label>
    <arm_group_label>Neuromuscular electrical stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bilateral and Unilateral lung transplant;&#xD;
&#xD;
          -  After extubation of invasive mechanical ventilation up to 48 hours for stable&#xD;
             patients;&#xD;
&#xD;
          -  After extubation of invasive mechanical ventilation up to 72 hours for those who are&#xD;
             present in the instability;&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Cystic fibrosis&#xD;
&#xD;
          -  Fibrotic pulmonary idiopathic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Skin lesions at the electrode placement points.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Graciele Sbruzzi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital of Clinics of Porto Alegre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Graciele Sbruzzi</last_name>
    <phone>+555133085857</phone>
    <email>graciele.sbruzzi@ufrgs.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>HCPA</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90.035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Graciele Sbruzzi, doctor</last_name>
      <phone>+55 51 3359-7334</phone>
      <phone_ext>(51) 3359-7334</phone_ext>
      <email>gsbruzzi@hcpa.edu.br</email>
    </contact>
    <contact_backup>
      <last_name>Luma Zanatta de Oliveira, graduate</last_name>
      <phone>+55 51 998473359</phone>
      <email>lumazanatta@hotmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Irmandade da Santa Casa de Misericórdia de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035-072</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rodrigo Della Méa Plentz, Doctor</last_name>
      <email>roplentz@yahoo.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Isadora Rebolho Sisto, Graduate</last_name>
      <email>isadora_sisto@hotmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>José de Jesus Peixoto Camargo, Doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sadi Marcelo Schio, Doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Juliessa Florian, Doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Isadora Rebolho Sisto, Graduate</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rodrigo Della Méa Plentz, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03788876
org study id: 20180497
nct id: NCT03788876
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Femoral quadriceps muscle thickness
time frame: three weeks
description: Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE).
measure: Muscle quadriceps muscle quality Evaluation of muscle quality through ultrasound images
time frame: three weeks
description: Performed through a Portable Ultrasound System (VIVID i®, GE) with a linear arrangement probe (60 mm, 7.5 MHz - VIVID i®, GE).
measure: Muscle Strength - Scale Medical Research Council (MRC)
time frame: three weeks
description: 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.
measure: Dynamometry
time frame: three weeks
description: Dynamometry = handgrip test
measure: Sit and stand up
time frame: three weeks
description: 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.
measure: 30 meter walk test
time frame: three weeks
description: Evaluates walking speed for six minutes
measure: Spirometry
time frame: three weeks
description: Evaluates lung function
measure: Blood Markers
time frame: three weeks
description: Evaluates markers of muscle injury.
measure: Hydric balance
time frame: three weeks
description: Through patient records
measure: length of stay in the ICU
time frame: three weeks
description: Through patient records
measure: Length of stay in invasive mechanical ventilation
time frame: three weeks
description: Through patient records
measure: Time of weaning from invasive mechanical ventilation
time frame: three weeks
description: Through patient records
measure: Survival Rate
time frame: three weeks
description: Through patient records
measure: Success of weaning from invasive mechanical ventilation
time frame: three weeks
description: Through patient records
arm group label: Neuromuscular electrical stimulation
arm group type: Active Comparator
description: 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.
arm group label: Conventional care
arm group type: Sham Comparator
description: 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.
intervention type: Other
intervention name: Neuromuscular electrical stimulation
description: 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.
arm group label: Neuromuscular electrical stimulation
intervention type: Other
intervention name: Conventional care
description: 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.
arm group label: Conventional care
arm group label: Neuromuscular electrical stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Graciele Sbruzzi
role: Principal Investigator
affiliation: Hospital of Clinics of Porto Alegre
last name: Graciele Sbruzzi
phone: +555133085857
email: graciele.sbruzzi@ufrgs.br
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Brazil
responsible party type: Sponsor
sharing ipd: No