<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/NCT03800485</url>
  </required_header>
  <id_info>
    <org_study_id>2017-10-4-HCUVA</org_study_id>
    <nct_id>NCT03800485</nct_id>
  </id_info>
  <brief_title>Inspiratory Muscle Training in Patients With Stroke in Subacute Phase.</brief_title>
  <official_title>Effects of Inspiratory Muscle Training on Lung Function, Inspiratory Muscle Strength and Trunk Balance in Patients With Stroke in Subacute Phase.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario Virgen de la Arrixaca</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad Católica San Antonio de Murcia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad Miguel Hernandez de Elche</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitario Virgen de la Arrixaca</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk&#xD;
      balance in survivors of stroke in the subacute phase of the disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk&#xD;
      balance in survivors of stroke in the subacute phase of the disease. The intervention will be&#xD;
      done in a group of patients who will be treated in the rehabilitation service at the Virgen&#xD;
      de la Arrixaca Hospital. They will train using a threshold IMT device or a Powerbreathe&#xD;
      device, to increase their inspiratory muscle strength in addition to a physical therapy&#xD;
      treatment. The intervention will last eigtht weeks and the patients will be evaluated at the&#xD;
      beginning and at the end of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">January 20, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2019</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>
    <intervention_model_description>There are two groups, the intervention group and the placebo group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>The study is blinded so neither the patient, neither the psysical therapist nor the investigator knows in which group the patient is</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum inspiratory pressure</measure>
    <time_frame>From the first day of evaluation and at eight weeks of the beginning of the intervention</time_frame>
    <description>The change of the maximum inspiratory pressure from the beginning, at 4 weeks and At 8 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forzed vital capacity</measure>
    <time_frame>From the first day of evaluation and at eight weeks of the beginning of the intervention</time_frame>
    <description>The change of the forzed vital capacity from the beginning and at the end of the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forzed espiratory volume in the first second</measure>
    <time_frame>From the first day of evaluation and at eight weeks of the beginning of the intervention</time_frame>
    <description>The change of the forzed espiratory volumen in the first second beginning and in the end of the intervention using a spirometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Voluntary maximum ventilation</measure>
    <time_frame>From the first day of evaluation and at eight weeks of the beginning of the intervention</time_frame>
    <description>The change of the voluntary maximum ventilation from the beginning and at the end of the intervention using a spirometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The &quot;Berg balance scale&quot; Test</measure>
    <time_frame>From the first day of evaluation and at Eight weeks of the beginning of the intervention</time_frame>
    <description>The change of the balance at the beginning and in the end of the intervention using the berg balance scale tool. The máximum value of this scale is 56 points, and the mínimum is 0 points. A higher value represents a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The postural assessment scale for stroke patients (PASS )test</measure>
    <time_frame>From the first day of evaluation and at Eight weeks of the beginning of the intervention</time_frame>
    <description>The change of the balance of the trunk at the beginning and in the end of the intervention using the postural assessment scale for stroke patinents tool. The maximum value of tris scale is 36 points. The minimum is 0 points.Higher values represents a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trunk control test (TCT)</measure>
    <time_frame>From the first day of evaluation and at Eight weeks of the beginning of the intervention</time_frame>
    <description>The change of the trunk control at the beginning and in the end of the intervention. The maximum value is 100 points, and the minimum 0 points. Higher values represents a better outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quadriceps dynamometry</measure>
    <time_frame>From the first day of evaluation and at eight weeks of the beginning of the intervention</time_frame>
    <description>The change of the quadriceps´s strength with a hand held dynamometer at the beginning and in the end of the intervention. Higher values represents a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>&quot;Functional ambulatory classificator&quot; Test</measure>
    <time_frame>From the first day of evaluation and at Eight weeks of the beginning of the intervention</time_frame>
    <description>The change of the walking capacity using the functional ambulatory classificator tool at the beginning and in the end of the intervention. The máximum value is 5 and the mínimum 0. Higher values represents a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>&quot;Functional ambulatory classificator Hospital de Sagunto&quot; Test</measure>
    <time_frame>From the first day of evaluation and at Eight weeks of the beginning of the intervention</time_frame>
    <description>The change of the walking capacity using the functional ambulatory classificator hospital de sagunto tool at the beginning and ni the end. The máximum value is 5 and the mínimum 0. Higher valúes represents better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 health survey</measure>
    <time_frame>From the first day of evaluation and at eight weeks of the beginning of the intervention</time_frame>
    <description>The change of the quality of life related to health with the SF-36 health survey at the beginning and in the end of the intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Stroke Rehabilitation</condition>
  <arm_group>
    <arm_group_label>IMT-GE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the participants will perform a training protocol of the inspiratory muscles during 8 weeks with a load that will increase from the 15% of the maximal inspiratory preassure until the 60% of the maximal inspiratory preassure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMT-GP</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The participants will perform a training protocol of the inspiratory muscles during 8 weeks with a load that will be the 10% of the maximal inspiratory preassure during all the 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IMT</intervention_name>
    <description>A training protocol of the inspiratory muscles that goes from the 15% of the maximal inspiratory muscle preassure until the 60% of the maximal inspiratory muscle preassure during 8 weeks</description>
    <arm_group_label>IMT-GE</arm_group_label>
    <arm_group_label>IMT-GP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sroke 6 months before of the beginning of the study&#xD;
&#xD;
          -  Be able to understand simple commands&#xD;
&#xD;
          -  Hemiparesis or hemiplegia&#xD;
&#xD;
          -  Not have serious cardiopulmonary diseases(COPD,asthma,bronchiectasis)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Associated neurological pathology leading to muscle weakness&#xD;
&#xD;
          -  Severe respiratory pathology, pulmonary embolism, presence of tracheostomy cannula,&#xD;
&#xD;
          -  intracranial hypertension&#xD;
&#xD;
          -  Acute retinal datachment, recent eye surgery&#xD;
&#xD;
          -  Impossibility of labial occlusion&#xD;
&#xD;
          -  Unstable heart disease, unstable angina, aortic aneurysm&#xD;
&#xD;
          -  Recent thoracic or abdominal surgery(6 months)&#xD;
&#xD;
          -  Uncontrolled arterial hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MARTHA C LEON GARZON, PhD</last_name>
    <role>Study Director</role>
    <affiliation>UNIVERSIDAD SAN ANTONIO DE MURCIA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>SILVANA L DE OLIVEIRA SOUSA, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidad Miguel Hernandez, Elche</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ALICIA TOVAR ALCARAZ, Pt</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Virgen de la Arrixaca</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ALICIA TOVAR ALCARAZ, MS</last_name>
    <phone>+34606160702</phone>
    <email>aliciatovar78@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>SILVANA L DE OLIVEIRA SOUSA, PhD</last_name>
    <phone>+34687184400</phone>
    <email>soliveira@umh.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Alicia Tovar Alcaraz</name>
      <address>
        <city>Murcia</city>
        <zip>30009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ALICIA TOVAR ALCARAZ, Pt</last_name>
      <phone>+34606160702</phone>
      <email>aliciatovar78@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>SILVANA L DE OLIVEIRA SOUSA, PhD</last_name>
      <phone>+34687184400</phone>
      <email>soliveira@umh.es</email>
    </contact_backup>
    <investigator>
      <last_name>ALICIA TOVAR ALCARAZ, Pt</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>SILVANA L DE OLIVEIRA SOUSA, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>MARTHA C LEON GARZON, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>MARIA J GONZALEZ CARRILLO, Pt</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Messaggi-Sartor M, Guillen-Sola A, Depolo M, Duarte E, Rodriguez DA, Barrera MC, Barreiro E, Escalada F, Orozco-Levi M, Marco E. Inspiratory and expiratory muscle training in subacute stroke: A randomized clinical trial. Neurology. 2015 Aug 18;85(7):564-72. doi: 10.1212/WNL.0000000000001827. Epub 2015 Jul 15.</citation>
    <PMID>26180145</PMID>
  </results_reference>
  <results_reference>
    <citation>Sutbeyaz ST, Koseoglu F, Inan L, Coskun O. Respiratory muscle training improves cardiopulmonary function and exercise tolerance in subjects with subacute stroke: a randomized controlled trial. Clin Rehabil. 2010 Mar;24(3):240-50. doi: 10.1177/0269215509358932. Epub 2010 Feb 15.</citation>
    <PMID>20156979</PMID>
  </results_reference>
  <results_reference>
    <citation>Kulnik ST, Birring SS, Moxham J, Rafferty GF, Kalra L. Does respiratory muscle training improve cough flow in acute stroke? Pilot randomized controlled trial. Stroke. 2015 Feb;46(2):447-53. doi: 10.1161/STROKEAHA.114.007110. Epub 2014 Dec 11.</citation>
    <PMID>25503549</PMID>
  </results_reference>
  <results_reference>
    <citation>Kim CY, Lee JS, Kim HD, Kim IS. Effects of the combination of respiratory muscle training and abdominal drawing-in maneuver on respiratory muscle activity in patients with post-stroke hemiplegia: a pilot randomized controlled trial. Top Stroke Rehabil. 2015 Aug;22(4):262-70. doi: 10.1179/1074935714Z.0000000020. Epub 2015 Feb 18.</citation>
    <PMID>26258451</PMID>
  </results_reference>
  <results_reference>
    <citation>Jung KM, Bang DH. Effect of inspiratory muscle training on respiratory capacity and walking ability with subacute stroke patients: a randomized controlled pilot trial. J Phys Ther Sci. 2017 Feb;29(2):336-339. doi: 10.1589/jpts.29.336. Epub 2017 Feb 24.</citation>
    <PMID>28265169</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario Virgen de la Arrixaca</investigator_affiliation>
    <investigator_full_name>Alicia Tovar Alcaraz</investigator_full_name>
    <investigator_title>Physical therapist</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>respiratory muscles</keyword>
  <keyword>lung</keyword>
  <keyword>stroke rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The individual participant data includes the spirometry data</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>February 17, 2022</submitted>
    <returned>April 28, 2022</returned>
  </pending_results>
  <!-- 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/NCT03800485
org study id: 2017-10-4-HCUVA
nct id: NCT03800485
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk
      balance in survivors of stroke in the subacute phase of the disease
Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk
      balance in survivors of stroke in the subacute phase of the disease. The intervention will be
      done in a group of patients who will be treated in the rehabilitation service at the Virgen
      de la Arrixaca Hospital. They will train using a threshold IMT device or a Powerbreathe
      device, to increase their inspiratory muscle strength in addition to a physical therapy
      treatment. The intervention will last eigtht weeks and the patients will be evaluated at the
      beginning and at the end of the intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: There are two groups, the intervention group and the placebo group.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: The study is blinded so neither the patient, neither the psysical therapist nor the investigator knows in which group the patient is
measure: Maximum inspiratory pressure
time frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
description: The change of the maximum inspiratory pressure from the beginning, at 4 weeks and At 8 weeks
measure: Forzed vital capacity
time frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
description: The change of the forzed vital capacity from the beginning and at the end of the intervention
measure: Forzed espiratory volume in the first second
time frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
description: The change of the forzed espiratory volumen in the first second beginning and in the end of the intervention using a spirometer
measure: Voluntary maximum ventilation
time frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
description: The change of the voluntary maximum ventilation from the beginning and at the end of the intervention using a spirometer
measure: The "Berg balance scale" Test
time frame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
description: The change of the balance at the beginning and in the end of the intervention using the berg balance scale tool. The máximum value of this scale is 56 points, and the mínimum is 0 points. A higher value represents a better outcome.
measure: The postural assessment scale for stroke patients (PASS )test
time frame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
description: The change of the balance of the trunk at the beginning and in the end of the intervention using the postural assessment scale for stroke patinents tool. The maximum value of tris scale is 36 points. The minimum is 0 points.Higher values represents a better outcome.
measure: Trunk control test (TCT)
time frame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
description: The change of the trunk control at the beginning and in the end of the intervention. The maximum value is 100 points, and the minimum 0 points. Higher values represents a better outcome
measure: Quadriceps dynamometry
time frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
description: The change of the quadriceps´s strength with a hand held dynamometer at the beginning and in the end of the intervention. Higher values represents a better outcome
measure: "Functional ambulatory classificator" Test
time frame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
description: The change of the walking capacity using the functional ambulatory classificator tool at the beginning and in the end of the intervention. The máximum value is 5 and the mínimum 0. Higher values represents a better outcome
measure: "Functional ambulatory classificator Hospital de Sagunto" Test
time frame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
description: The change of the walking capacity using the functional ambulatory classificator hospital de sagunto tool at the beginning and ni the end. The máximum value is 5 and the mínimum 0. Higher valúes represents better outcome
measure: SF-36 health survey
time frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
description: The change of the quality of life related to health with the SF-36 health survey at the beginning and in the end of the intervention
arm group label: IMT-GE
arm group type: Experimental
description: the participants will perform a training protocol of the inspiratory muscles during 8 weeks with a load that will increase from the 15% of the maximal inspiratory preassure until the 60% of the maximal inspiratory preassure.
arm group label: IMT-GP
arm group type: Placebo Comparator
description: The participants will perform a training protocol of the inspiratory muscles during 8 weeks with a load that will be the 10% of the maximal inspiratory preassure during all the 8 weeks
intervention type: Device
intervention name: IMT
description: A training protocol of the inspiratory muscles that goes from the 15% of the maximal inspiratory muscle preassure until the 60% of the maximal inspiratory muscle preassure during 8 weeks
arm group label: IMT-GE
arm group label: IMT-GP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: MARTHA C LEON GARZON, PhD
role: Study Director
affiliation: UNIVERSIDAD SAN ANTONIO DE MURCIA
last name: SILVANA L DE OLIVEIRA SOUSA, PhD
role: Study Director
affiliation: Universidad Miguel Hernandez, Elche
last name: ALICIA TOVAR ALCARAZ, Pt
role: Principal Investigator
affiliation: Hospital Universitario Virgen de la Arrixaca
last name: ALICIA TOVAR ALCARAZ, MS
phone: +34606160702
email: aliciatovar78@hotmail.com
last name: SILVANA L DE OLIVEIRA SOUSA, PhD
phone: +34687184400
email: soliveira@umh.es
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Spain
citation: Messaggi-Sartor M, Guillen-Sola A, Depolo M, Duarte E, Rodriguez DA, Barrera MC, Barreiro E, Escalada F, Orozco-Levi M, Marco E. Inspiratory and expiratory muscle training in subacute stroke: A randomized clinical trial. Neurology. 2015 Aug 18;85(7):564-72. doi: 10.1212/WNL.0000000000001827. Epub 2015 Jul 15.
PMID: 26180145
citation: Sutbeyaz ST, Koseoglu F, Inan L, Coskun O. Respiratory muscle training improves cardiopulmonary function and exercise tolerance in subjects with subacute stroke: a randomized controlled trial. Clin Rehabil. 2010 Mar;24(3):240-50. doi: 10.1177/0269215509358932. Epub 2010 Feb 15.
PMID: 20156979
citation: Kulnik ST, Birring SS, Moxham J, Rafferty GF, Kalra L. Does respiratory muscle training improve cough flow in acute stroke? Pilot randomized controlled trial. Stroke. 2015 Feb;46(2):447-53. doi: 10.1161/STROKEAHA.114.007110. Epub 2014 Dec 11.
PMID: 25503549
citation: Kim CY, Lee JS, Kim HD, Kim IS. Effects of the combination of respiratory muscle training and abdominal drawing-in maneuver on respiratory muscle activity in patients with post-stroke hemiplegia: a pilot randomized controlled trial. Top Stroke Rehabil. 2015 Aug;22(4):262-70. doi: 10.1179/1074935714Z.0000000020. Epub 2015 Feb 18.
PMID: 26258451
citation: Jung KM, Bang DH. Effect of inspiratory muscle training on respiratory capacity and walking ability with subacute stroke patients: a randomized controlled pilot trial. J Phys Ther Sci. 2017 Feb;29(2):336-339. doi: 10.1589/jpts.29.336. Epub 2017 Feb 24.
PMID: 28265169
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario Virgen de la Arrixaca
investigator full name: Alicia Tovar Alcaraz
investigator title: Physical therapist
mesh term: Respiratory Aspiration
mesh term: Stroke
sharing ipd: Undecided
ipd description: The individual participant data includes the spirometry data
submitted: February 17, 2022
returned: April 28, 2022