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/NCT05977166</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REL/012/003546</org_study_id>
      <nct_id>NCT05977166</nct_id>
    </id_info>
    <brief_title>Hyperbaric on Pulmonary Functions in Post Covid -19 Patients.</brief_title>
    <official_title>Influence of Hyperbaric Oxygen on Pulmonary Functions in Post Covid-19 Patients.</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>
        Purpose of the study is to investigate the effect of hyperbaric oxygen on FVC, FEV1 and on&#xD;
        oxygen saturation in post-COVID-19 patients, The effect of breathing exercises in form of&#xD;
        diaphragmatic breathing exercise and pursed lip breathing with traditional medical treatment&#xD;
        in form of (vitamin D, vitamin C and anticoagulation drugs on FVC, FEV1 and on oxygen&#xD;
        saturation in post-COVID-19 patients.and the difference between the effect of hyperbaric and&#xD;
        breathing exercises in form of diaphragmatic breathing exercise and pursed lip breathing with&#xD;
        traditional medical treatment in form of (vitamin D, vitamin C and anticoagulation drugs on&#xD;
        FVC, FEV1 and on oxygen saturation in post-COVID-19 patients&#xD;
  &#xD;
        Seventy two covid-19 patients from both genders ranged in age chronology from twenty one to&#xD;
        sixty six years will be conducted to participate in this study .Selection of the study sample&#xD;
        and evaluate of pulmonary functions improvement as well as hyperbaric oxygen therapy will be&#xD;
        conducted at Agriculture Hospital in El Mansoura town.&#xD;
  &#xD;
        The study sample will be divided randomly into two equal groups of(A&amp;B).All patients&#xD;
        participated in the current study will receive breathing excesses in form of Diaphragmatic&#xD;
        breathing exercise and Pursed lip breathing with traditional medical treatment in form of&#xD;
        (vitamin D, vitamin C and Anticoagulation drugs ,group A will receive 60 minutes of&#xD;
        HBOT(100%oxygen at 2 ATA with five minutes air breaks every twenty minutes daily in morning&#xD;
        for three weeks then take period time of rest about 30 minutes before starting breathing&#xD;
        exercise.&#xD;
  &#xD;
        The Body mass index (BMI) of each participated patient will be determined by measuring&#xD;
        weight/ Kg and height/ m2 using Electronic weight and height scale to include BMI 25.0-29.9&#xD;
        Kg/ . Also using Digital spirometer SMP 21/01 RD (Russian) for measuring of FVC parameters ,&#xD;
        to be less than 80% ,FEV1 to be less than 80% and Pulse Oximeter for measuring Oxygen&#xD;
        saturation to range from 90%to 95% assessment will be done before and after treatment.&#xD;
  &#xD;
        The obtained results of this study will measure Forced vital capacity (FVC), Forced&#xD;
        expiratory volume (FEV1) and oxygen saturation to determine the significant improvement of&#xD;
        participated patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 7, 2022</start_date>
    <completion_date type="Actual">June 1, 2023</completion_date>
    <primary_completion_date type="Actual">June 21, 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>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>forced vital capacity,</measure>
      <time_frame>3 Months</time_frame>
      <description>by spirometer</description>
    </primary_outcome>
    <primary_outcome>
      <measure>forced expiratory volume</measure>
      <time_frame>3 Months</time_frame>
      <description>by spirometer</description>
    </primary_outcome>
    <primary_outcome>
      <measure>oxygen saturation</measure>
      <time_frame>3 Months</time_frame>
      <description>pulse oximeter</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">72</enrollment>
    <condition>Post COVID-19 Patients</condition>
    <arm_group>
      <arm_group_label>hyperbaric oxygen therapy ,breathing exercise,medical treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Hyperbaric oxygen treatment HBO treatment was given daily in the morning on 21 consecutive days. (HBOT) treatment is a procedure performed inside a pressured chamber (the Hyperbaric Chamber). The patient is place inside the chamber exposure to 100% oxygen at 2 ATA with 5 min air breaks every 20 min. Each session consisted of 60 min. Measurements will be taken in the morning before entering, the first and last session.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>breathing exercise and medical treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>breathing exercise completely each session of three repetitions initially. Every repetition consisted of one round of intervention 10-15 times followed by a brief rest (normal breathing) of &lt;1 min (one repetition). Such 3 repetitions were given initially &amp; advanced till 10 repetitions (one session) by last day of the week. In this manner participants practised 3 sessions twice a day, for a total duration of about 10-20 min every day.Vitamin D: The recommended dietary dose of vitamin D is 600 IU each day .&#xD;
  Vitamine C: The recommended dietary dose 200 mg/day vitamin C. Anticoagulation drugs (blood thinners), doctors usually prescribe low-molecular-weight heparin (enoxaparin) (30 mg), each given subcutaneously every 12 hours</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>hyperbaric oxygen therapy</intervention_name>
      <description>All patients participated in the current study will receive breathing excesses in form of Diaphragmatic breathing exercise and Pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and Anticoagulation drugs ,group A will receive 60 minutes of HBOT(100%oxygen at 2 ATA with five minutes air breaks every twenty minutes daily in morning for three weeks then take period time of rest about 30 minutes before starting breathing exercise.</description>
      <arm_group_label>breathing exercise and medical treatment</arm_group_label>
      <arm_group_label>hyperbaric oxygen therapy ,breathing exercise,medical treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>breathing exercise</intervention_name>
      <description>All patients participated in the current study will receive breathing excesses in form of Diaphragmatic breathing exercise and Pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and Anticoagulation drugs ,group A will receive 60 minutes of HBOT(100%oxygen at 2 ATA with five minutes air breaks every twenty minutes daily in morning for three weeks then take period time of rest about 30 minutes before starting breathing exercise.</description>
      <arm_group_label>breathing exercise and medical treatment</arm_group_label>
      <arm_group_label>hyperbaric oxygen therapy ,breathing exercise,medical treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>medical treatment</intervention_name>
      <description>All patients participated in the current study will receive breathing excesses in form of Diaphragmatic breathing exercise and Pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and Anticoagulation drugs ,group A will receive 60 minutes of HBOT(100%oxygen at 2 ATA with five minutes air breaks every twenty minutes daily in morning for three weeks then take period time of rest about 30 minutes before starting breathing exercise.</description>
      <arm_group_label>breathing exercise and medical treatment</arm_group_label>
      <arm_group_label>hyperbaric oxygen therapy ,breathing exercise,medical treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
            -  1. post Covid -19 patients (2weeks after recovery).&#xD;
  &#xD;
               2.post Covid -19 patients with deficiency in forced vital capacity (less than 80%)&#xD;
               forced expiratory volume (less than 80%) lower oxygen saturation (90%-95%).&#xD;
  &#xD;
               3.age (21-66)years old.&#xD;
  &#xD;
               4.both gender.&#xD;
  &#xD;
               5.BMI 25.0-29.9.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. COPD or other respiratory diseases.&#xD;
  &#xD;
            2. Neurological disease.&#xD;
  &#xD;
            3. mental illness.&#xD;
  &#xD;
            4. Critically ill patients with intubation.&#xD;
  &#xD;
            5. smokers.&#xD;
  &#xD;
            6. Inner ear diseases.&#xD;
  &#xD;
            7. pregnancy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>66 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Enas Faraman</last_name>
      <role>Principal Investigator</role>
      <affiliation>physiothyrapist at kafer Elshikh general Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Faculty of Physical Therapy</name>
        <address>
          <city>Giza</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Enas Faraman Mohamed</investigator_full_name>
      <investigator_title>Physiothery</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</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/NCT05977166
  org study id: P.T.REL/012/003546
  nct id: NCT05977166
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Purpose of the study is to investigate the effect of hyperbaric oxygen on FVC, FEV1 and on
        oxygen saturation in post-COVID-19 patients, The effect of breathing exercises in form of
        diaphragmatic breathing exercise and pursed lip breathing with traditional medical treatment
        in form of (vitamin D, vitamin C and anticoagulation drugs on FVC, FEV1 and on oxygen
        saturation in post-COVID-19 patients.and the difference between the effect of hyperbaric and
        breathing exercises in form of diaphragmatic breathing exercise and pursed lip breathing with
        traditional medical treatment in form of (vitamin D, vitamin C and anticoagulation drugs on
        FVC, FEV1 and on oxygen saturation in post-COVID-19 patients
  
        Seventy two covid-19 patients from both genders ranged in age chronology from twenty one to
        sixty six years will be conducted to participate in this study .Selection of the study sample
        and evaluate of pulmonary functions improvement as well as hyperbaric oxygen therapy will be
        conducted at Agriculture Hospital in El Mansoura town.
  
        The study sample will be divided randomly into two equal groups of(A&B).All patients
        participated in the current study will receive breathing excesses in form of Diaphragmatic
        breathing exercise and Pursed lip breathing with traditional medical treatment in form of
        (vitamin D, vitamin C and Anticoagulation drugs ,group A will receive 60 minutes of
        HBOT(100%oxygen at 2 ATA with five minutes air breaks every twenty minutes daily in morning
        for three weeks then take period time of rest about 30 minutes before starting breathing
        exercise.
  
        The Body mass index (BMI) of each participated patient will be determined by measuring
        weight/ Kg and height/ m2 using Electronic weight and height scale to include BMI 25.0-29.9
        Kg/ . Also using Digital spirometer SMP 21/01 RD (Russian) for measuring of FVC parameters ,
        to be less than 80% ,FEV1 to be less than 80% and Pulse Oximeter for measuring Oxygen
        saturation to range from 90%to 95% assessment will be done before and after treatment.
  
        The obtained results of this study will measure Forced vital capacity (FVC), Forced
        expiratory volume (FEV1) and oxygen saturation to determine the significant improvement of
        participated patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: forced vital capacity,
  time frame: 3 Months
  description: by spirometer
  measure: forced expiratory volume
  time frame: 3 Months
  description: by spirometer
  measure: oxygen saturation
  time frame: 3 Months
  description: pulse oximeter
  arm group label: hyperbaric oxygen therapy ,breathing exercise,medical treatment
  arm group type: Active Comparator
  description: Hyperbaric oxygen treatment HBO treatment was given daily in the morning on 21 consecutive days. (HBOT) treatment is a procedure performed inside a pressured chamber (the Hyperbaric Chamber). The patient is place inside the chamber exposure to 100% oxygen at 2 ATA with 5 min air breaks every 20 min. Each session consisted of 60 min. Measurements will be taken in the morning before entering, the first and last session.
  arm group label: breathing exercise and medical treatment
  arm group type: Active Comparator
  description: breathing exercise completely each session of three repetitions initially. Every repetition consisted of one round of intervention 10-15 times followed by a brief rest (normal breathing) of <1 min (one repetition). Such 3 repetitions were given initially & advanced till 10 repetitions (one session) by last day of the week. In this manner participants practised 3 sessions twice a day, for a total duration of about 10-20 min every day.Vitamin D: The recommended dietary dose of vitamin D is 600 IU each day .
  Vitamine C: The recommended dietary dose 200 mg/day vitamin C. Anticoagulation drugs (blood thinners), doctors usually prescribe low-molecular-weight heparin (enoxaparin) (30 mg), each given subcutaneously every 12 hours
  intervention type: Device
  intervention name: hyperbaric oxygen therapy
  description: All patients participated in the current study will receive breathing excesses in form of Diaphragmatic breathing exercise and Pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and Anticoagulation drugs ,group A will receive 60 minutes of HBOT(100%oxygen at 2 ATA with five minutes air breaks every twenty minutes daily in morning for three weeks then take period time of rest about 30 minutes before starting breathing exercise.
  arm group label: breathing exercise and medical treatment
  arm group label: hyperbaric oxygen therapy ,breathing exercise,medical treatment
  intervention type: Device
  intervention name: breathing exercise
  description: All patients participated in the current study will receive breathing excesses in form of Diaphragmatic breathing exercise and Pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and Anticoagulation drugs ,group A will receive 60 minutes of HBOT(100%oxygen at 2 ATA with five minutes air breaks every twenty minutes daily in morning for three weeks then take period time of rest about 30 minutes before starting breathing exercise.
  arm group label: breathing exercise and medical treatment
  arm group label: hyperbaric oxygen therapy ,breathing exercise,medical treatment
  intervention type: Drug
  intervention name: medical treatment
  description: All patients participated in the current study will receive breathing excesses in form of Diaphragmatic breathing exercise and Pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and Anticoagulation drugs ,group A will receive 60 minutes of HBOT(100%oxygen at 2 ATA with five minutes air breaks every twenty minutes daily in morning for three weeks then take period time of rest about 30 minutes before starting breathing exercise.
  arm group label: breathing exercise and medical treatment
  arm group label: hyperbaric oxygen therapy ,breathing exercise,medical treatment
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 66 Years
  healthy volunteers: No
  last name: Enas Faraman
  role: Principal Investigator
  affiliation: physiothyrapist at kafer Elshikh general Hospital
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Enas Faraman Mohamed
  investigator title: Physiothery
  mesh term: COVID-19
  sharing ipd: No