<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/NCT03763019</url>
  </required_header>
  <id_info>
    <org_study_id>54022451-050.05.04</org_study_id>
    <nct_id>NCT03763019</nct_id>
  </id_info>
  <brief_title>Effects of Respiratory Exercises in Patients With Hemiplegia</brief_title>
  <official_title>Correlation of Pulmonary Function Test and Ultrasonographic Diaphragm Measurements in Patients With Hemiplegia and Investigation of the Effects of Respiratory Exercises on These Parameters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif University</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>
      This study evaluates the effects of respiratory exercises on respiratory function test&#xD;
      parameters and ultrasonographic diaphragmatic measurements. Half of the hemiplegic patients&#xD;
      will receive respiratory and neurophysiological exercises, while other half will receive only&#xD;
      neurophysiological exercises.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After stroke, diaphragm, the most important muscle of respiration, is wasted as well as the&#xD;
      other muscles of the affected side.&#xD;
&#xD;
      Ultrasonography is a non-invasive, practical, low cost utility that may measure the thickness&#xD;
      of diaphragm in maximum expiration and inspiration thus examining the functionality of the&#xD;
      muscle. Correlation between respiratory functional tests and diaphragm ultrasonography has&#xD;
      been proven in recent literature. In this manner, the aim of this study is twofold. First is&#xD;
      to determine whether ultrasonography can be used practically to evaluate the respiratory&#xD;
      functions of the patients after stroke. Respiratory function tests will be used for the&#xD;
      correlation analysis. Second is to evaluate the effectiveness of respiratory exercises via&#xD;
      diaphragm ultrasonography and respiratory function tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 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>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Forced vital capacity (FVC)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Measured by spirometry. &gt;80% is normal. If the value is lower than the normal limit it indicates either an obstructive or restrictive disease. The lower values show a poorer outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced expiratory volume in one second (FEV1)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The maximal amount of air you can forcefully exhale in one second. Measured by spirometry. &gt;80% is normal. If there is an obstruction, this measurement shows the severity of the obstruciton. The lower values show a poorer outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tiffeneau-Pinelli index</measure>
    <time_frame>6 weeks</time_frame>
    <description>A calculated ratio used in the diagnosis of obstructive and restrictive lung disease. Calculated as FEV1/FVC. &gt;80% is normal. ≤80% indicates an obstructive pulmonary disease.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced expiratory flow at 25% and 75% (FEF 25-75%)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The average forced expiratory flow during the mid (25% - 75%) portion of the FVC. Shows small and medium airway obstruction. &gt;70% is normal. It shows the small airways impariment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diaphragmatic thickening fraction (TF)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Thickness of the diaphragm is measured from the zone of apposition (subcostal area between anterior axillary line and mid-axillary line) via ultrasonography. After diaphragm thickness in end expiration (thickness in functional residual capacity- TFRC) and in end inspiration (thickness in total lung capacity- TTLC) are obtained. Thickening fraction is calculated as [TTLC-TFRC/TFRC]x100. A higher value shows a better outcome.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hemiplegia</condition>
  <condition>Respiratory Abnormality</condition>
  <arm_group>
    <arm_group_label>Respiratory rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional rehabilitation program aiming to normalize movement patterns and minimize spasticity. Including static and dynamic control of position, balance skills, weight shift, and activities of daily living. 45 minutes, once daily.&#xD;
Respiratory exercises 30 minutes, once daily, (incentive spirometric trainer, forced expiration, percussion, postural drainage etc.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional rehabilitation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Conventional rehabilitation program aiming to normalize movement patterns and minimize spasticity. Including static and dynamic control of position, balance skills, weight shift, and activities of daily living. 45 minutes, once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional rehabilitation</intervention_name>
    <description>Static and dynamic control of position, balance skills, weight shift, and activities of daily living.</description>
    <arm_group_label>Conventional rehabilitation</arm_group_label>
    <arm_group_label>Respiratory rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Respiratory rehabilitation</intervention_name>
    <description>Forced expiration, forced inspiration (thoracal expansion exercise), coughing exercise, incentive spirometric trainer, diaphragmatic respiration exercise, autogenic drainage, percussion.</description>
    <arm_group_label>Respiratory rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stroke confirmed radiologically&#xD;
&#xD;
          -  Unilateral hemiplegia&#xD;
&#xD;
          -  First stroke episode&#xD;
&#xD;
          -  Mini Mental score ≥ 24&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to consent and understand&#xD;
&#xD;
          -  Chronic cardiac disease&#xD;
&#xD;
          -  Pulmonary disease (asthma, restrictive or obstructive pulmonary disease)&#xD;
&#xD;
          -  Facial paralysis&#xD;
&#xD;
          -  History of thoracic or abdominal surgery&#xD;
&#xD;
          -  Being alcoholic&#xD;
&#xD;
          -  Using psychotropic drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ozan Volkan Yurdakul, MD</last_name>
    <role>Study Director</role>
    <affiliation>Bezmialem University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bezmialem Vakıf Univesity</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Jung KJ, Park JY, Hwang DW, Kim JH, Kim JH. Ultrasonographic diaphragmatic motion analysis and its correlation with pulmonary function in hemiplegic stroke patients. Ann Rehabil Med. 2014 Feb;38(1):29-37. doi: 10.5535/arm.2014.38.1.29. Epub 2014 Feb 25.</citation>
    <PMID>24639923</PMID>
  </reference>
  <reference>
    <citation>Kim M, Lee K, Cho J, Lee W. Diaphragm Thickness and Inspiratory Muscle Functions in Chronic Stroke Patients. Med Sci Monit. 2017 Mar 11;23:1247-1253. doi: 10.12659/msm.900529.</citation>
    <PMID>28284044</PMID>
  </reference>
  <reference>
    <citation>Cardenas LZ, Santana PV, Caruso P, Ribeiro de Carvalho CR, Pereira de Albuquerque AL. Diaphragmatic Ultrasound Correlates with Inspiratory Muscle Strength and Pulmonary Function in Healthy Subjects. Ultrasound Med Biol. 2018 Apr;44(4):786-793. doi: 10.1016/j.ultrasmedbio.2017.11.020. Epub 2018 Jan 17.</citation>
    <PMID>29373153</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>February 3, 2020</last_update_submitted>
  <last_update_submitted_qc>February 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hemiplegia</keyword>
  <keyword>respiratory function tests</keyword>
  <keyword>respiratory exercises</keyword>
  <keyword>diaphragm ultrasonography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemiplegia</mesh_term>
  </condition_browse>
  <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/NCT03763019
org study id: 54022451-050.05.04
nct id: NCT03763019
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effects of respiratory exercises on respiratory function test
      parameters and ultrasonographic diaphragmatic measurements. Half of the hemiplegic patients
      will receive respiratory and neurophysiological exercises, while other half will receive only
      neurophysiological exercises.
After stroke, diaphragm, the most important muscle of respiration, is wasted as well as the
      other muscles of the affected side.

      Ultrasonography is a non-invasive, practical, low cost utility that may measure the thickness
      of diaphragm in maximum expiration and inspiration thus examining the functionality of the
      muscle. Correlation between respiratory functional tests and diaphragm ultrasonography has
      been proven in recent literature. In this manner, the aim of this study is twofold. First is
      to determine whether ultrasonography can be used practically to evaluate the respiratory
      functions of the patients after stroke. Respiratory function tests will be used for the
      correlation analysis. Second is to evaluate the effectiveness of respiratory exercises via
      diaphragm ultrasonography and respiratory function tests.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Forced vital capacity (FVC)
time frame: 6 weeks
description: The amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Measured by spirometry. >80% is normal. If the value is lower than the normal limit it indicates either an obstructive or restrictive disease. The lower values show a poorer outcome
measure: Forced expiratory volume in one second (FEV1)
time frame: 6 weeks
description: The maximal amount of air you can forcefully exhale in one second. Measured by spirometry. >80% is normal. If there is an obstruction, this measurement shows the severity of the obstruciton. The lower values show a poorer outcome.
measure: Tiffeneau-Pinelli index
time frame: 6 weeks
description: A calculated ratio used in the diagnosis of obstructive and restrictive lung disease. Calculated as FEV1/FVC. >80% is normal. ≤80% indicates an obstructive pulmonary disease.
measure: Forced expiratory flow at 25% and 75% (FEF 25-75%)
time frame: 6 weeks
description: The average forced expiratory flow during the mid (25% - 75%) portion of the FVC. Shows small and medium airway obstruction. >70% is normal. It shows the small airways impariment
measure: Diaphragmatic thickening fraction (TF)
time frame: 6 weeks
description: Thickness of the diaphragm is measured from the zone of apposition (subcostal area between anterior axillary line and mid-axillary line) via ultrasonography. After diaphragm thickness in end expiration (thickness in functional residual capacity- TFRC) and in end inspiration (thickness in total lung capacity- TTLC) are obtained. Thickening fraction is calculated as [TTLC-TFRC/TFRC]x100. A higher value shows a better outcome.
arm group label: Respiratory rehabilitation
arm group type: Active Comparator
description: Conventional rehabilitation program aiming to normalize movement patterns and minimize spasticity. Including static and dynamic control of position, balance skills, weight shift, and activities of daily living. 45 minutes, once daily.
Respiratory exercises 30 minutes, once daily, (incentive spirometric trainer, forced expiration, percussion, postural drainage etc.)
arm group label: Conventional rehabilitation
arm group type: Placebo Comparator
description: Conventional rehabilitation program aiming to normalize movement patterns and minimize spasticity. Including static and dynamic control of position, balance skills, weight shift, and activities of daily living. 45 minutes, once daily.
intervention type: Procedure
intervention name: Conventional rehabilitation
description: Static and dynamic control of position, balance skills, weight shift, and activities of daily living.
arm group label: Conventional rehabilitation
arm group label: Respiratory rehabilitation
intervention type: Procedure
intervention name: Respiratory rehabilitation
description: Forced expiration, forced inspiration (thoracal expansion exercise), coughing exercise, incentive spirometric trainer, diaphragmatic respiration exercise, autogenic drainage, percussion.
arm group label: Respiratory rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Ozan Volkan Yurdakul, MD
role: Study Director
affiliation: Bezmialem University
facility: 
country: Turkey
citation: Jung KJ, Park JY, Hwang DW, Kim JH, Kim JH. Ultrasonographic diaphragmatic motion analysis and its correlation with pulmonary function in hemiplegic stroke patients. Ann Rehabil Med. 2014 Feb;38(1):29-37. doi: 10.5535/arm.2014.38.1.29. Epub 2014 Feb 25.
PMID: 24639923
citation: Kim M, Lee K, Cho J, Lee W. Diaphragm Thickness and Inspiratory Muscle Functions in Chronic Stroke Patients. Med Sci Monit. 2017 Mar 11;23:1247-1253. doi: 10.12659/msm.900529.
PMID: 28284044
citation: Cardenas LZ, Santana PV, Caruso P, Ribeiro de Carvalho CR, Pereira de Albuquerque AL. Diaphragmatic Ultrasound Correlates with Inspiratory Muscle Strength and Pulmonary Function in Healthy Subjects. Ultrasound Med Biol. 2018 Apr;44(4):786-793. doi: 10.1016/j.ultrasmedbio.2017.11.020. Epub 2018 Jan 17.
PMID: 29373153
responsible party type: Sponsor
mesh term: Hemiplegia
sharing ipd: No