xml: <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/NCT06012474</url>
    </required_header>
    <id_info>
      <org_study_id>012/004209</org_study_id>
      <nct_id>NCT06012474</nct_id>
    </id_info>
    <brief_title>Effect Of Power Breath Device On Arterial Blood Gases And Diaphragmatic Excursion After Valve Surgery</brief_title>
    <official_title>Effect Of Power Breath Device On Arterial Blood Gases And Diaphragmatic Excursion After Valve Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</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>
        The aim of this study is to evaluate the effect of power breath device on arterial blood&#xD;
        gases, diaphragmatic excursion and the 6 min walk test after cardiac valve surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        No more studies have been done on the effect of IMT by power breath on valvular surgery, So,&#xD;
        this study will see the effect of power breath device on arterial blood gases, diaphragmatic&#xD;
        excursion and six minute walk test after valve surgery to know enhanced recovery protocols in&#xD;
        valvular surgery that accelerate the functional recovery, minimize the length of the hospital&#xD;
        stay and decrease cost of treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Actual">October 15, 2022</completion_date>
    <primary_completion_date type="Actual">May 15, 2022</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>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Assessing the change in diaphragmatic excursion</measure>
      <time_frame>within 24 hours after 1 week of intervention</time_frame>
      <description>By using Ultrasonography (Aloka prosound 4000, made in Japan) that will be used to assess diaphragmatic excursion. Diaphragmatic excursion is measured 3 times :at baseline before surgical intervention, second day after surgery (before the training program) and after 7 days of training program for all patient in the two groups. Diaphragmatic excursion was measured during deep breathing while the patient in semi-recumbent position on a comfortable bed using ultrasonography.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessing the change in Arterial Blood gases</measure>
      <time_frame>within 24 hours after 1 week of intervention</time_frame>
      <description>Arterial blood gases are measured at baseline before surgical intervention, second day after surgery (before the training program) and after 7 days of training program for all patient in the two groups and can be obtained by direct arterial puncture most usually at the wrist (radial artery), femoral and brachial artery. An arterial blood sample (2 to 3 ml) will be collected.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessing the change in capacity to perform daily activities</measure>
      <time_frame>within 24 hours after 1 week of intervention</time_frame>
      <description>by using the The 6-min walk test (6MWT) is a submaximal functional test indicative of the capacity to perform daily activities, patients will be asked to walk along a 30-m, flat and straight hospital corridor. Encouragement will be offered every minute, so that subjects will walk as far as possible. Symptom-limited interruptions (dyspnea, skeletal muscle pain, angina, dizziness) will allowed, though patients will be invited to resume walking as soon as possible. Most tests will be supervised by a physical therapist. Distance will be recorded in meters. Subjective dyspnea will quantified according to Borg Scale, ranging from 0 (no dyspnea) to 10 (severe dyspnea).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">50</enrollment>
    <condition>Heart Valve Diseases</condition>
    <arm_group>
      <arm_group_label>inspiratory muscle training group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>30 patients will receive inspiratory muscle training by Power breath device once daily for 7 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>diaphragmatic breathing exercise group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>20 patients will receive program of diaphragmatic breathing exercise by incentive spirometer once daily for 7 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Power breath plus</intervention_name>
      <description>Power breath plus use a variable load calibrated spring. It can be adjusted from the lowest load setting (17cmH2O) when training began and increased as the patient breathing muscles adapt and become stronger (maximum load setting 274cmH2O). Use a comfortable chair, preferably straight-back so that the spine is straight at all times during the exercise. patients will be instructed to exhale calmly, followed by a maximal forced inspiration to total lung capacity using a mouthpiece and a nasal clip as an aid to prevent air leaks and will ask to make 10 breaths for 3 sets once daily for 7 days with 2min rest between sets</description>
      <arm_group_label>inspiratory muscle training group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Incrementing the training load</intervention_name>
      <description>The resistance will be increased incrementally, based on the rate of perceived exertion (RPE) scored by the patient on the modified Borg Scale. If the RPE is less than 5, the resistance of the inspiratory trainer will be increased incrementally by 2cmH2O. The resistance will not change if the level of perceived exertion is rated from 6 to 8, and the resistance will be decreased by 1 to 2 cmH2O if the level of perceived exertion is rated 9 or 10.</description>
      <arm_group_label>inspiratory muscle training group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Diaphragmatic breathing exercises</intervention_name>
      <description>Training by using incentive spirometer:&#xD;
  Loosen any tight clothing, especially around neck.&#xD;
  Each patient will be instructed to sit upright with placing incentive spirometer at the same level of his mouth to promote optimal lung expansion while using the spirometer.&#xD;
  The patient will be instructed to exhale letting all the breath out.&#xD;
  patient will asked to close the lips around the mouthpiece of the spirometer.&#xD;
  patient will be instructed to inhale slowly, breathing in until unable to do any more, this would raise the balls to the top of the column.&#xD;
  patient will be asked to hold the breath as long as possible (at least five seconds) then exhale slowly.&#xD;
  Session will be in the form of 30 times in sets, each set consist of 5-6 repetitions with rest 1 minute between sets.&#xD;
  Intensity of exercise will be increased by increasing time of session, time of holding the breath and numbers of repetitions according to patient's status.</description>
      <arm_group_label>diaphragmatic breathing exercise group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female patients with valve surgery (valve replacement or repair with median sternotomy&#xD;
               procedure).&#xD;
  &#xD;
            -  Age between 25 to 35 years old.&#xD;
  &#xD;
            -  BMI is between 18.5 to 24.5 kg/m2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          The participants will be excluded if they meet one of the following criteria:&#xD;
  &#xD;
            -  Uncontrolled hypertension (systolic blood pressure&gt;230 mm Hg and diastolic blood&#xD;
               pressure&gt;120 mm Hg)&#xD;
  &#xD;
            -  Patients with coronary artery disease or heart failure.&#xD;
  &#xD;
            -  Need for mechanical ventilation for &gt;24 h or reintubation.&#xD;
  &#xD;
            -  Renal and hepatic disorders.&#xD;
  &#xD;
            -  Infected or unstable sternum.&#xD;
  &#xD;
            -  patient with pneumothorax after surgery.&#xD;
  &#xD;
            -  Metabolic disorders.&#xD;
  &#xD;
            -  Pregnant woman.&#xD;
  &#xD;
            -  Lactating mother.&#xD;
  &#xD;
            -  Smokers&#xD;
  &#xD;
            -  Stroke patient&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hend Mahdy</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Outpatient clinic faculty of physical therapy cairo university</name>
        <address>
          <city>Dokki</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Hend Mahdy Hassan Mohamed</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Valve Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012474
  org study id: 012/004209
  nct id: NCT06012474
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the effect of power breath device on arterial blood
        gases, diaphragmatic excursion and the 6 min walk test after cardiac valve surgery.
  No more studies have been done on the effect of IMT by power breath on valvular surgery, So,
        this study will see the effect of power breath device on arterial blood gases, diaphragmatic
        excursion and six minute walk test after valve surgery to know enhanced recovery protocols in
        valvular surgery that accelerate the functional recovery, minimize the length of the hospital
        stay and decrease cost of treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Participant, Investigator)
  measure: Assessing the change in diaphragmatic excursion
  time frame: within 24 hours after 1 week of intervention
  description: By using Ultrasonography (Aloka prosound 4000, made in Japan) that will be used to assess diaphragmatic excursion. Diaphragmatic excursion is measured 3 times :at baseline before surgical intervention, second day after surgery (before the training program) and after 7 days of training program for all patient in the two groups. Diaphragmatic excursion was measured during deep breathing while the patient in semi-recumbent position on a comfortable bed using ultrasonography.
  measure: Assessing the change in Arterial Blood gases
  time frame: within 24 hours after 1 week of intervention
  description: Arterial blood gases are measured at baseline before surgical intervention, second day after surgery (before the training program) and after 7 days of training program for all patient in the two groups and can be obtained by direct arterial puncture most usually at the wrist (radial artery), femoral and brachial artery. An arterial blood sample (2 to 3 ml) will be collected.
  measure: Assessing the change in capacity to perform daily activities
  time frame: within 24 hours after 1 week of intervention
  description: by using the The 6-min walk test (6MWT) is a submaximal functional test indicative of the capacity to perform daily activities, patients will be asked to walk along a 30-m, flat and straight hospital corridor. Encouragement will be offered every minute, so that subjects will walk as far as possible. Symptom-limited interruptions (dyspnea, skeletal muscle pain, angina, dizziness) will allowed, though patients will be invited to resume walking as soon as possible. Most tests will be supervised by a physical therapist. Distance will be recorded in meters. Subjective dyspnea will quantified according to Borg Scale, ranging from 0 (no dyspnea) to 10 (severe dyspnea).
  arm group label: inspiratory muscle training group
  arm group type: Experimental
  description: 30 patients will receive inspiratory muscle training by Power breath device once daily for 7 days.
  arm group label: diaphragmatic breathing exercise group
  arm group type: Active Comparator
  description: 20 patients will receive program of diaphragmatic breathing exercise by incentive spirometer once daily for 7 days.
  intervention type: Other
  intervention name: Power breath plus
  description: Power breath plus use a variable load calibrated spring. It can be adjusted from the lowest load setting (17cmH2O) when training began and increased as the patient breathing muscles adapt and become stronger (maximum load setting 274cmH2O). Use a comfortable chair, preferably straight-back so that the spine is straight at all times during the exercise. patients will be instructed to exhale calmly, followed by a maximal forced inspiration to total lung capacity using a mouthpiece and a nasal clip as an aid to prevent air leaks and will ask to make 10 breaths for 3 sets once daily for 7 days with 2min rest between sets
  arm group label: inspiratory muscle training group
  intervention type: Other
  intervention name: Incrementing the training load
  description: The resistance will be increased incrementally, based on the rate of perceived exertion (RPE) scored by the patient on the modified Borg Scale. If the RPE is less than 5, the resistance of the inspiratory trainer will be increased incrementally by 2cmH2O. The resistance will not change if the level of perceived exertion is rated from 6 to 8, and the resistance will be decreased by 1 to 2 cmH2O if the level of perceived exertion is rated 9 or 10.
  arm group label: inspiratory muscle training group
  intervention type: Other
  intervention name: Diaphragmatic breathing exercises
  description: Training by using incentive spirometer:
  Loosen any tight clothing, especially around neck.
  Each patient will be instructed to sit upright with placing incentive spirometer at the same level of his mouth to promote optimal lung expansion while using the spirometer.
  The patient will be instructed to exhale letting all the breath out.
  patient will asked to close the lips around the mouthpiece of the spirometer.
  patient will be instructed to inhale slowly, breathing in until unable to do any more, this would raise the balls to the top of the column.
  patient will be asked to hold the breath as long as possible (at least five seconds) then exhale slowly.
  Session will be in the form of 30 times in sets, each set consist of 5-6 repetitions with rest 1 minute between sets.
  Intensity of exercise will be increased by increasing time of session, time of holding the breath and numbers of repetitions according to patient's status.
  arm group label: diaphragmatic breathing exercise group
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hend Mahdy
  role: Principal Investigator
  affiliation: Cairo University
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Hend Mahdy Hassan Mohamed
  investigator title: Principal Investigator
  mesh term: Heart Valve Diseases
  sharing ipd: No