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/NCT05988294</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/004571</org_study_id>
      <nct_id>NCT05988294</nct_id>
    </id_info>
    <brief_title>Pilates Exercises in Patients With Inhalation Injury</brief_title>
    <official_title>Pulmonary Function, Respiratory Muscle Strength and Functional Capacity Response to Pilates Exercises in Patients With Inhalation Injury After Thermal Burn.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Inhalation injury is a composite of multiple insults including: supraglottic thermal injury,&#xD;
        subglottic airway and alveolar poisoning, and systemic poisoning from absorbed small molecule&#xD;
        toxins. These contaminant insults independently affect each of the pulmonary functions as&#xD;
        well as having a direct effect on systemic physiology. Further, anatomic characteristics can&#xD;
        predispose patients to inhalation injury. For example, an infant will develop airway&#xD;
        obstructions much faster than an adult due to reduced airway diameter. Understanding the&#xD;
        contributions of each of these pathologies to the patient's disease is critical to managing&#xD;
        inhalation injury.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Extra lung mucus secretions, injured mucosa, contaminants, and aspirated substances should be&#xD;
        handled in their early stages. In the case of fibrinous material transudates, compromised&#xD;
        mucociliary secretions and mucosal slough must be cleared. There are different methods to&#xD;
        assist the clearance of secretions as bronchoscopy, ventilator, mucolytics, suction, and&#xD;
        chest physiotherapy.&#xD;
  &#xD;
        In Pilates method (PM), several muscles are activated, including the muscles involved in&#xD;
        breathing, especially to improve the expiratory function, which remains contracted during the&#xD;
        inspiratory and expiratory phase. Breathing control is fundamental during the execution of PM&#xD;
        exercises, where the practitioner learns how to breathe properly as an essential part of each&#xD;
        exercise through forceful exhaling followed by complete inhaling. Thus, adequate breathing&#xD;
        aids in controlling movements, and therefore, the method can be regarded as an indirect&#xD;
        strategy for respiratory muscle training. It is known that poor control of breathing can&#xD;
        result in compensation and lung volumes and respiratory muscle performance, with several&#xD;
        factors involved.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 30, 2023</start_date>
    <completion_date type="Anticipated">May 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</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>Single (Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Forced vital capacity (FVC)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Forced vital capacity (FVC) will be measured by using spirometer</description>
    </primary_outcome>
    <primary_outcome>
      <measure>forced expiratory volume in 1 second (FEV1)</measure>
      <time_frame>12 weeks</time_frame>
      <description>forced expiratory volume in 1 second (FEV1) will be measured by using spirometer</description>
    </primary_outcome>
    <primary_outcome>
      <measure>peak expiratory flow (PEF)</measure>
      <time_frame>12 weeks</time_frame>
      <description>peak expiratory flow (PEF) will be measured by using spirometer</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Respiratory muscle strength</measure>
      <time_frame>12 weeks</time_frame>
      <description>The inspiratory muscle strength will be verified by means of the maximum inspiratory pressure (MIP) and the expiratory muscular strength by means of maximum expiratory pressure (MEP) by using the digital Manovacuometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional capacity</measure>
      <time_frame>12 weeks</time_frame>
      <description>By using 6-Minute Walk Test (6-MWT) that measures the maximum distance walked in a period of 6 min to assess the submaximal level of the functional capacity of the participants</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Inhalation Injury</condition>
    <arm_group>
      <arm_group_label>Group A (Pilates Group)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive Pilates exercises for 60 minutes followed by conventional physical therapy program for 45 minutes, 3 days/ week for 12 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B (Control Group)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants will receive conventional physical therapy program (diaphragmatic deep breathing exercises, bronchial hygiene techniques, assisted cough, stretching exercises and ROM exercises for both upper and lower limbs) for 45 minutes, 3 days/ week for 12 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pilates exercises</intervention_name>
      <description>One-hour Pilates exercise program was given by a certified trainer to patients three times per week for 12 weeks. The exercise program followed the basic principles of the Pilates method. Our protocol comprised the following components of Pilates-based exercises: strength and stabilization, flexibility and range of motion, proper body alignment, balance, coordination, and body awareness. Resistance bands and 26 cm Pilates balls were used as supportive equipment. The exercise sections consisted of 5 minutes breathing, 10 minutes warm-up, 35 minutes conditioning phase and 10 minutes cool-down.</description>
      <arm_group_label>Group A (Pilates Group)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conventional physical therapy exercise program</intervention_name>
      <description>Diaphragmatic deep breathing exercises, bronchial hygiene techniques, assisted cough, stretching exercises and ROM exercises for both upper and lower limbs for 45 minutes, 3 days/ week for 12 weeks.</description>
      <arm_group_label>Group A (Pilates Group)</arm_group_label>
      <arm_group_label>Group B (Control Group)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients in both sexes and their age will range from 20-50 years.&#xD;
  &#xD;
            2. Six weeks after deep second-degree thermal burn with inhalation injury (until complete&#xD;
               healing) with 35%-40% total body surface area (TBSA).&#xD;
  &#xD;
            3. Patients suffering from retained secretions which did not respond to medical&#xD;
               treatment. (4) All patients should be clinically and medically stable.&#xD;
  &#xD;
          (5) All patients should have the same medical treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participants with a history of regular physical activity (regular exercise habit &gt; 3&#xD;
               times/ week or &gt;150 min/ week) in the last 6 months.&#xD;
  &#xD;
            2. Participants with less than an 85% attendance rate at the sessions.&#xD;
  &#xD;
            3. Participants with any dysfunction that limit physical activity such as neurological&#xD;
               disorders, chronic obstructive pulmonary disease, uncontrolled hypertension,&#xD;
               malignancy, cardiovascular diseases, deep vein thrombosis, rheumatoid arthritis,&#xD;
               orthopedic problems, such as fracture on the pelvic or limbs, a visual impairment, or&#xD;
               hearing impairments and contractures.&#xD;
  &#xD;
            4. Smokers.&#xD;
  &#xD;
            5. Pregnant females.&#xD;
  &#xD;
            6. Obese participants (BMI &gt; 30 kg/m2).&#xD;
  &#xD;
            7. Participants use non-invasive mechanical ventilation and intubation or need for&#xD;
               intensive clinical support and/or transfer to the Intensive Care Unit.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Doaa A Elimy, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Lecturer of basic science, Faculty of Physical Therapy Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nesma M Allam, PhD</last_name>
      <phone>+201281968332</phone>
      <email>dr.nesma2011@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of Physical Therapy</name>
        <address>
          <city>Giza</city>
          <zip>12111</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nesma M Allam, PhD</last_name>
        <phone>+201281968332</phone>
        <email>dr.nesma2011@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Nesma Morgan Allam</investigator_full_name>
      <investigator_title>Assistant Professor of physical therapy for surgery, Faculty of physical therapy</investigator_title>
    </responsible_party>
    <keyword>Pilates exercises</keyword>
    <keyword>Pulmonary Function</keyword>
    <keyword>Respiratory Muscle Strength</keyword>
    <keyword>Functional Capacity Response</keyword>
    <keyword>Inhalation Injury</keyword>
    <keyword>Thermal Burn</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Aspiration</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Study results</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>6 months after publication</ipd_time_frame>
      <ipd_access_criteria>Study protocol</ipd_access_criteria>
    </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/NCT05988294
  org study id: P.T.REC/012/004571
  nct id: NCT05988294
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Inhalation injury is a composite of multiple insults including: supraglottic thermal injury,
        subglottic airway and alveolar poisoning, and systemic poisoning from absorbed small molecule
        toxins. These contaminant insults independently affect each of the pulmonary functions as
        well as having a direct effect on systemic physiology. Further, anatomic characteristics can
        predispose patients to inhalation injury. For example, an infant will develop airway
        obstructions much faster than an adult due to reduced airway diameter. Understanding the
        contributions of each of these pathologies to the patient's disease is critical to managing
        inhalation injury.
  Extra lung mucus secretions, injured mucosa, contaminants, and aspirated substances should be
        handled in their early stages. In the case of fibrinous material transudates, compromised
        mucociliary secretions and mucosal slough must be cleared. There are different methods to
        assist the clearance of secretions as bronchoscopy, ventilator, mucolytics, suction, and
        chest physiotherapy.
  
        In Pilates method (PM), several muscles are activated, including the muscles involved in
        breathing, especially to improve the expiratory function, which remains contracted during the
        inspiratory and expiratory phase. Breathing control is fundamental during the execution of PM
        exercises, where the practitioner learns how to breathe properly as an essential part of each
        exercise through forceful exhaling followed by complete inhaling. Thus, adequate breathing
        aids in controlling movements, and therefore, the method can be regarded as an indirect
        strategy for respiratory muscle training. It is known that poor control of breathing can
        result in compensation and lung volumes and respiratory muscle performance, with several
        factors involved.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Care Provider)
  measure: Forced vital capacity (FVC)
  time frame: 12 weeks
  description: Forced vital capacity (FVC) will be measured by using spirometer
  measure: forced expiratory volume in 1 second (FEV1)
  time frame: 12 weeks
  description: forced expiratory volume in 1 second (FEV1) will be measured by using spirometer
  measure: peak expiratory flow (PEF)
  time frame: 12 weeks
  description: peak expiratory flow (PEF) will be measured by using spirometer
  measure: Respiratory muscle strength
  time frame: 12 weeks
  description: The inspiratory muscle strength will be verified by means of the maximum inspiratory pressure (MIP) and the expiratory muscular strength by means of maximum expiratory pressure (MEP) by using the digital Manovacuometer
  measure: Functional capacity
  time frame: 12 weeks
  description: By using 6-Minute Walk Test (6-MWT) that measures the maximum distance walked in a period of 6 min to assess the submaximal level of the functional capacity of the participants
  arm group label: Group A (Pilates Group)
  arm group type: Experimental
  description: Participants will receive Pilates exercises for 60 minutes followed by conventional physical therapy program for 45 minutes, 3 days/ week for 12 weeks.
  arm group label: Group B (Control Group)
  arm group type: Other
  description: Participants will receive conventional physical therapy program (diaphragmatic deep breathing exercises, bronchial hygiene techniques, assisted cough, stretching exercises and ROM exercises for both upper and lower limbs) for 45 minutes, 3 days/ week for 12 weeks.
  intervention type: Other
  intervention name: Pilates exercises
  description: One-hour Pilates exercise program was given by a certified trainer to patients three times per week for 12 weeks. The exercise program followed the basic principles of the Pilates method. Our protocol comprised the following components of Pilates-based exercises: strength and stabilization, flexibility and range of motion, proper body alignment, balance, coordination, and body awareness. Resistance bands and 26 cm Pilates balls were used as supportive equipment. The exercise sections consisted of 5 minutes breathing, 10 minutes warm-up, 35 minutes conditioning phase and 10 minutes cool-down.
  arm group label: Group A (Pilates Group)
  intervention type: Other
  intervention name: Conventional physical therapy exercise program
  description: Diaphragmatic deep breathing exercises, bronchial hygiene techniques, assisted cough, stretching exercises and ROM exercises for both upper and lower limbs for 45 minutes, 3 days/ week for 12 weeks.
  arm group label: Group A (Pilates Group)
  arm group label: Group B (Control Group)
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Doaa A Elimy, PhD
  role: Study Director
  affiliation: Lecturer of basic science, Faculty of Physical Therapy Cairo University
  last name: Nesma M Allam, PhD
  phone: +201281968332
  email: dr.nesma2011@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Nesma Morgan Allam
  investigator title: Assistant Professor of physical therapy for surgery, Faculty of physical therapy
  mesh term: Respiratory Aspiration
  mesh term: Wounds and Injuries
  sharing ipd: Yes
  ipd description: Study results
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: 6 months after publication
  ipd access criteria: Study protocol