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/NCT06004310</url>
    </required_header>
    <id_info>
      <org_study_id>683</org_study_id>
      <nct_id>NCT06004310</nct_id>
    </id_info>
    <brief_title>Effect of Pulmonary Rehabilitation Among Post-COVID-19 Patients in a Tertiary Care Hospital in Bangladesh</brief_title>
    <official_title>Effect of Pulmonary Rehabilitation Among Post-COVID-19 Patients in a Tertiary Care Hospital in Bangladesh: A Quasi-Experimental Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</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>
        This quasi-experimental study aims to evaluate the efficacy and safety of pulmonary&#xD;
        rehabilitation in post-COVID-19 patients and compare differences in primary outcomes before&#xD;
        and after pulmonary rehabilitation. Its main aim is to provide an answer to the following&#xD;
        question: What are the outcomes of pulmonary rehabilitation in post-COVID-19 patients in a&#xD;
        tertiary care facility in Bangladesh? The participants will participate in 06 weeks of&#xD;
        comprehensive multimodal and multidisciplinary outpatient pulmonary rehabilitation, including&#xD;
        endurance training, strength training, patient education, relaxation techniques,&#xD;
        psychological support, and nutritional counseling.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: The 2019 novel coronavirus, belonging to the β species of coronaviruses,&#xD;
        primarily spreads through respiratory droplets and close contact. Even after recovering from&#xD;
        the infection, COVID-19 can lead to various chronic health issues, with impaired lung&#xD;
        function, reduced exercise performance, and diminished quality of life being prevalent among&#xD;
        a significant proportion of patients. In Bangladesh, post-COVID-19 patients represent a&#xD;
        considerable population who have overcome the acute phase of the infection but continue to&#xD;
        face numerous social, psychological, and physical challenges. Among these challenges,&#xD;
        respiratory complications such as persistent cough, shortness of breath, and decreased lung&#xD;
        function are frequently observed in post-COVID-19 patients in Bangladesh. In addition, these&#xD;
        individuals often experience fatigue, muscle weakness, and joint pain. These physical&#xD;
        symptoms can profoundly impact their daily activities and overall quality of life,&#xD;
        necessitating ongoing medical care and rehabilitation.&#xD;
  &#xD;
        Purpose: To evaluate the efficacy of pulmonary rehabilitation in post-COVID-19 patients and&#xD;
        to compare differences in outcomes between before and after pulmonary rehabilitation&#xD;
        Methodology: It will be a hospital-based quasi-experimental study. The investigator will&#xD;
        conveniently select adult post-COVID-19 patients whose respiratory symptoms (fatigue,&#xD;
        exertional dyspnea, etc.) persist longer than 12 weeks from the onset of their first symptoms&#xD;
        from outpatient and inpatient of the Department of Respiratory Medicine, Bangabandhu Sheikh&#xD;
        Mujib Medical University. Participants will participate in a 06-weeks (Two sessions per week)&#xD;
        comprehensive multimodal and multidisciplinary outpatient pulmonary rehabilitation. In-person&#xD;
        interviews will be done for data collection. The total sample size will be 130. Before the&#xD;
        study, the research protocol will be approved by the Institutional Review Board (IRB) of&#xD;
        Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka.&#xD;
  &#xD;
        Expected outcome: The study's findings will reveal the benefits of pulmonary rehabilitation&#xD;
        among post-COVID-19 patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">May 25, 2023</start_date>
    <completion_date type="Anticipated">May 24, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 25, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>The study will be a quasi-experimental study and carried out at Bangabandhu Sheikh Mujib Medical University. A consecutive sampling method will be used. The participants will engage in a comprehensive 06-weeks outpatient multimodal and multidisciplinary pulmonary rehabilitation program.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Distance: Six-minute walking test (6MWT)</measure>
      <time_frame>After enrollment and after 6 weeks when complete the pulmonary rehabilitation</time_frame>
      <description>The following equipment will be required:&#xD;
  Stopwatch, Measuring/trundle wheel to measure distance covered, A 30-meter stretch of unimpeded walkway, Two cones to mark the space that needs to be covered, Pulse oximeter for measuring heart rate and SpO2, Borg Breathlessness Scale</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Respiratory outcomes: FVC, FEV1, FEV1/FVC ratio, DLCO</measure>
      <time_frame>After enrollment and after 6 weeks when complete the pulmonary rehabilitation</time_frame>
      <description>FVC (Forced vital capacity) - This is the amount of air exhaled forcefully and quickly after inhaling as much as patient can.&#xD;
  FEV1 (Forced expiratory volume in 1 second ) - The maximum amount of air that the subject can forcibly expel during the first second following maximal inhalation.&#xD;
  FEV1/FVC ratio - The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs DLCO (Diffusing lung capacity for carbon monoxide) - The ability of the lungs to transfer gas from inhaled air to the red blood cells in pulmonary capillaries.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of life: Short Form 36 Health Survey Questionnaire (SF-36)</measure>
      <time_frame>After enrollment and after 6 weeks when complete the pulmonary rehabilitation</time_frame>
      <description>SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Laboratory investigations: CRP and D-dimer</measure>
      <time_frame>After enrollment and after 6 weeks when complete the pulmonary rehabilitation</time_frame>
      <description>CRP (C reactive protein) - A c-reactive protein test measures the level of c-reactive protein (CRP) in a sample of patient's blood D-dimer - A D-dimer test looks for D-dimer in blood. D-dimer is a protein fragment (small piece) that's made when a blood clot dissolves in body.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">130</enrollment>
    <condition>Pulmonary Pathology</condition>
    <arm_group>
      <arm_group_label>Post-COVID-19 Patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Post-COVID-19 patients are individuals who have recovered from the acute phase of COVID-19 but continue to experience lingering symptoms and health challenges for weeks or even months after their initial infection. These individuals are often referred to as &quot;long haulers&quot; or &quot;post-acute sequelae of SARS-CoV-2 infection&quot; (PASC) patients. The symptoms experienced by post-COVID-19 patients can vary widely and may include fatigue, shortness of breath, chest pain, joint pain, cognitive difficulties, and more. Medical professionals and researchers are working to better understand and address these conditions, providing supportive care and rehabilitation to help these patients regain their health and well-being.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Pulmonary Rehabilitation</intervention_name>
      <description>Participants will be participated a 06 weeks comprehensive outpatient pulmonary rehabilitation which includes endurance training, strength training, patient education, relaxation techniques, psychological support and nutritional counselling.</description>
      <arm_group_label>Post-COVID-19 Patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Previously RT-PCR positive for SARS-COV-2 and whose respiratory symptoms (fatigue,&#xD;
               exertional shortness of breath and cough) persists more than 3 weeks after the onset&#xD;
               of their first symptoms attending outpatient and admitted inpatient under the&#xD;
               department of Respiratory Medicine, Bangabandhu Sheikh Mujib Medical University,&#xD;
               Bangladesh&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  RT-PCR negative but respiratory symptoms (fatigue, exertional shortness of breath and&#xD;
               cough) persists more than 3 weeks after the onset of their first symptoms&#xD;
  &#xD;
            -  RT-PCR positive but respiratory symptoms (fatigue, exertional shortness of breath and&#xD;
               cough) not persists more than 3 weeks after the onset of their first symptoms&#xD;
  &#xD;
            -  Comorbidities like chronic lung disease, obstructive sleep apnea, coronary heart&#xD;
               disease, chronic kidney disease, stroke&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mohammed A Rahman, MBBS,MD,FCCP</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Bangabandhu Sheikh Mujib Medical University</name>
        <address>
          <city>Dhaka</city>
          <state>Shahbag</state>
          <zip>1000</zip>
          <country>Bangladesh</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Bangladesh</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</investigator_affiliation>
      <investigator_full_name>Prof Mohammed Atiqur Rahman</investigator_full_name>
      <investigator_title>Chairman, Department of Respiratory Medicine</investigator_title>
    </responsible_party>
    <keyword>Pulmonary rehabilitation,Post-COVID-19 patients,Bangladesh</keyword>
    <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/NCT06004310
  org study id: 683
  nct id: NCT06004310
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This quasi-experimental study aims to evaluate the efficacy and safety of pulmonary
        rehabilitation in post-COVID-19 patients and compare differences in primary outcomes before
        and after pulmonary rehabilitation. Its main aim is to provide an answer to the following
        question: What are the outcomes of pulmonary rehabilitation in post-COVID-19 patients in a
        tertiary care facility in Bangladesh? The participants will participate in 06 weeks of
        comprehensive multimodal and multidisciplinary outpatient pulmonary rehabilitation, including
        endurance training, strength training, patient education, relaxation techniques,
        psychological support, and nutritional counseling.
  Background: The 2019 novel coronavirus, belonging to the β species of coronaviruses,
        primarily spreads through respiratory droplets and close contact. Even after recovering from
        the infection, COVID-19 can lead to various chronic health issues, with impaired lung
        function, reduced exercise performance, and diminished quality of life being prevalent among
        a significant proportion of patients. In Bangladesh, post-COVID-19 patients represent a
        considerable population who have overcome the acute phase of the infection but continue to
        face numerous social, psychological, and physical challenges. Among these challenges,
        respiratory complications such as persistent cough, shortness of breath, and decreased lung
        function are frequently observed in post-COVID-19 patients in Bangladesh. In addition, these
        individuals often experience fatigue, muscle weakness, and joint pain. These physical
        symptoms can profoundly impact their daily activities and overall quality of life,
        necessitating ongoing medical care and rehabilitation.
  
        Purpose: To evaluate the efficacy of pulmonary rehabilitation in post-COVID-19 patients and
        to compare differences in outcomes between before and after pulmonary rehabilitation
        Methodology: It will be a hospital-based quasi-experimental study. The investigator will
        conveniently select adult post-COVID-19 patients whose respiratory symptoms (fatigue,
        exertional dyspnea, etc.) persist longer than 12 weeks from the onset of their first symptoms
        from outpatient and inpatient of the Department of Respiratory Medicine, Bangabandhu Sheikh
        Mujib Medical University. Participants will participate in a 06-weeks (Two sessions per week)
        comprehensive multimodal and multidisciplinary outpatient pulmonary rehabilitation. In-person
        interviews will be done for data collection. The total sample size will be 130. Before the
        study, the research protocol will be approved by the Institutional Review Board (IRB) of
        Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka.
  
        Expected outcome: The study's findings will reveal the benefits of pulmonary rehabilitation
        among post-COVID-19 patients.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The study will be a quasi-experimental study and carried out at Bangabandhu Sheikh Mujib Medical University. A consecutive sampling method will be used. The participants will engage in a comprehensive 06-weeks outpatient multimodal and multidisciplinary pulmonary rehabilitation program.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Distance: Six-minute walking test (6MWT)
  time frame: After enrollment and after 6 weeks when complete the pulmonary rehabilitation
  description: The following equipment will be required:
  Stopwatch, Measuring/trundle wheel to measure distance covered, A 30-meter stretch of unimpeded walkway, Two cones to mark the space that needs to be covered, Pulse oximeter for measuring heart rate and SpO2, Borg Breathlessness Scale
  measure: Respiratory outcomes: FVC, FEV1, FEV1/FVC ratio, DLCO
  time frame: After enrollment and after 6 weeks when complete the pulmonary rehabilitation
  description: FVC (Forced vital capacity) - This is the amount of air exhaled forcefully and quickly after inhaling as much as patient can.
  FEV1 (Forced expiratory volume in 1 second ) - The maximum amount of air that the subject can forcibly expel during the first second following maximal inhalation.
  FEV1/FVC ratio - The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs DLCO (Diffusing lung capacity for carbon monoxide) - The ability of the lungs to transfer gas from inhaled air to the red blood cells in pulmonary capillaries.
  measure: Quality of life: Short Form 36 Health Survey Questionnaire (SF-36)
  time frame: After enrollment and after 6 weeks when complete the pulmonary rehabilitation
  description: SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
  measure: Laboratory investigations: CRP and D-dimer
  time frame: After enrollment and after 6 weeks when complete the pulmonary rehabilitation
  description: CRP (C reactive protein) - A c-reactive protein test measures the level of c-reactive protein (CRP) in a sample of patient's blood D-dimer - A D-dimer test looks for D-dimer in blood. D-dimer is a protein fragment (small piece) that's made when a blood clot dissolves in body.
  arm group label: Post-COVID-19 Patients
  arm group type: Experimental
  description: Post-COVID-19 patients are individuals who have recovered from the acute phase of COVID-19 but continue to experience lingering symptoms and health challenges for weeks or even months after their initial infection. These individuals are often referred to as "long haulers" or "post-acute sequelae of SARS-CoV-2 infection" (PASC) patients. The symptoms experienced by post-COVID-19 patients can vary widely and may include fatigue, shortness of breath, chest pain, joint pain, cognitive difficulties, and more. Medical professionals and researchers are working to better understand and address these conditions, providing supportive care and rehabilitation to help these patients regain their health and well-being.
  intervention type: Behavioral
  intervention name: Pulmonary Rehabilitation
  description: Participants will be participated a 06 weeks comprehensive outpatient pulmonary rehabilitation which includes endurance training, strength training, patient education, relaxation techniques, psychological support and nutritional counselling.
  arm group label: Post-COVID-19 Patients
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mohammed A Rahman, MBBS,MD,FCCP
  role: Principal Investigator
  affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  facility: 
  country: Bangladesh
  responsible party type: Principal Investigator
  investigator affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  investigator full name: Prof Mohammed Atiqur Rahman
  investigator title: Chairman, Department of Respiratory Medicine
  mesh term: COVID-19
  sharing ipd: No