<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/NCT04445376</url>
  </required_header>
  <id_info>
    <org_study_id>313</org_study_id>
    <nct_id>NCT04445376</nct_id>
  </id_info>
  <brief_title>Effect of Physical Therapy Exercises on Cardiorespiratory Fitness Level in COVID19 Patients After Recovery.</brief_title>
  <official_title>Effect of Aerobic Exercises on Cardio-respiratory Fitness and Quality of Life in Recovered COVID 19 Recovered Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Government College University Faisalabad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Government College University Faisalabad</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>
      In some patients, lung function declined by about 20 to 30% after recovery. Computer&#xD;
      tomography of COVID-19 patients revealed a ground glass opacity in both lungs. We will&#xD;
      measure the Cardiorespiratory fitness according to American College of Sports medicine&#xD;
      guidline and provide physiotherapy exercise to the patients to measure the improvement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In December 2019, the first reports emerged of a novel severe acute respiratory syndrome&#xD;
      (SARS) coronavirus 2 (SARS-CoV-2) in Wuhan, China. The virus, which causes atypical pneumonia&#xD;
      progressing to acute lung injury and acute respiratory distress syndrome (ARDS) in some&#xD;
      individuals, was named COVID-19. The burden of fibrotic lung disease following SARS-CoV-2&#xD;
      infection is likely to be high; therefore, given the scale of the pandemic, the global burden&#xD;
      of fibrotic lung disease will probably increase considerably. The aim of this study is to&#xD;
      check the cardiorespiratory fitness level and the effect of Physical therapy intervention to&#xD;
      improve the Cardiorespiratory fitness level in patients recovered from COVID-19. Quality of&#xD;
      life has also been affected due to COVID19 due to decreased Cardiorespiratory fitness level,&#xD;
      and this study also aims to improve the quality of life of people recovered from COVID19.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 3, 2020</start_date>
  <completion_date type="Actual">October 3, 2020</completion_date>
  <primary_completion_date type="Actual">September 10, 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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6 minute walk test</measure>
    <time_frame>5 weeks</time_frame>
    <description>To measure the cardio-respiratory fitness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Borg Dyspnea Scale</measure>
    <time_frame>5 weeks</time_frame>
    <description>It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SF-36 QUESTIONNAIRE</measure>
    <time_frame>5 weeks</time_frame>
    <description>The SF-36 questionnaire consists of 36 items, which are used to calculate eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The first four scores can be summed to create the physical composite score (PCS), while the last four can be summed to create the mental composite score (MCS). Scores for the SF-36 scales range between 0 and 100, with higher scores indicating a better HRQOL</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Intervention Group (Ventilatory)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Breathing Exercise and Aerobic Training will be provided to all the patients.The training session will be given 3 days a week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention (Non ventilatory)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Breathing Exercise and Aerobic Training will be provided to all the patients.The training session will be given 3 days a week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Exercises</intervention_name>
    <description>Aerobic Training and Breathing Exercises.</description>
    <arm_group_label>Intervention (Non ventilatory)</arm_group_label>
    <arm_group_label>Intervention Group (Ventilatory)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recovered from COVID 19 disease (PCR report).&#xD;
&#xD;
          -  Sub-normal performance as compared to normative data.&#xD;
&#xD;
          -  Do not have any Respiratory Problem.&#xD;
&#xD;
          -  Consent to participate in the study.&#xD;
&#xD;
          -  Able to understand and perform the exercise.&#xD;
&#xD;
          -  Age from 18 to 75.&#xD;
&#xD;
          -  Dyspnea due to COVID19.&#xD;
&#xD;
          -  Modified Borg Dyspnea Scale score at least 2 but less than 7.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not suffered from COVID 19.&#xD;
&#xD;
          -  Respiratory Problem.&#xD;
&#xD;
          -  Resting Blood Pressure greater than 160/100 instead of taking medicine&#xD;
&#xD;
          -  Greater than 1-month post COVID19 Recovery.&#xD;
&#xD;
          -  Cardiorespiratory comorbidities which limit participation in exercise.&#xD;
&#xD;
          -  Any Musculoskeletal problem which limit participation in Training.&#xD;
&#xD;
          -  Other cardiovascular morbidity which would limit exercise tolerance (heart failure,&#xD;
             abnormal blood pressure responses or ST-segment depression &gt; 2mm, symptomatic aortic&#xD;
             stenosis, complex arrhythmias).&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Orthostatic blood pressure decrease of &gt;20 mmHg with symptoms&#xD;
&#xD;
          -  Hypertropic cardiomyopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ishtiaq Ahmed, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Government College University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bin Inam Rehabilitation Center.</name>
      <address>
        <city>Faisalābad</city>
        <state>Punjab</state>
        <zip>38000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>George PM, Wells AU, Jenkins RG. Pulmonary fibrosis and COVID-19: the potential role for antifibrotic therapy. Lancet Respir Med. 2020 Aug;8(8):807-815. doi: 10.1016/S2213-2600(20)30225-3. Epub 2020 May 15.</citation>
    <PMID>32422178</PMID>
  </reference>
  <reference>
    <citation>Belli S, Balbi B, Prince I, Cattaneo D, Masocco F, Zaccaria S, Bertalli L, Cattini F, Lomazzo A, Dal Negro F, Giardini M, Franssen FME, Janssen DJA, Spruit MA. Low physical functioning and impaired performance of activities of daily life in COVID-19 patients who survived hospitalisation. Eur Respir J. 2020 Oct 15;56(4):2002096. doi: 10.1183/13993003.02096-2020. Print 2020 Oct.</citation>
    <PMID>32764112</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Government College University Faisalabad</investigator_affiliation>
    <investigator_full_name>Ishtiaq Ahmed</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Cardiorespiratory fitness</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>


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/NCT04445376
org study id: 313
nct id: NCT04445376
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In some patients, lung function declined by about 20 to 30% after recovery. Computer
      tomography of COVID-19 patients revealed a ground glass opacity in both lungs. We will
      measure the Cardiorespiratory fitness according to American College of Sports medicine
      guidline and provide physiotherapy exercise to the patients to measure the improvement.
In December 2019, the first reports emerged of a novel severe acute respiratory syndrome
      (SARS) coronavirus 2 (SARS-CoV-2) in Wuhan, China. The virus, which causes atypical pneumonia
      progressing to acute lung injury and acute respiratory distress syndrome (ARDS) in some
      individuals, was named COVID-19. The burden of fibrotic lung disease following SARS-CoV-2
      infection is likely to be high; therefore, given the scale of the pandemic, the global burden
      of fibrotic lung disease will probably increase considerably. The aim of this study is to
      check the cardiorespiratory fitness level and the effect of Physical therapy intervention to
      improve the Cardiorespiratory fitness level in patients recovered from COVID-19. Quality of
      life has also been affected due to COVID19 due to decreased Cardiorespiratory fitness level,
      and this study also aims to improve the quality of life of people recovered from COVID19.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 6 minute walk test
time frame: 5 weeks
description: To measure the cardio-respiratory fitness.
measure: Modified Borg Dyspnea Scale
time frame: 5 weeks
description: It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal.
measure: SF-36 QUESTIONNAIRE
time frame: 5 weeks
description: The SF-36 questionnaire consists of 36 items, which are used to calculate eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The first four scores can be summed to create the physical composite score (PCS), while the last four can be summed to create the mental composite score (MCS). Scores for the SF-36 scales range between 0 and 100, with higher scores indicating a better HRQOL
arm group label: Intervention Group (Ventilatory)
arm group type: Experimental
description: Breathing Exercise and Aerobic Training will be provided to all the patients.The training session will be given 3 days a week.
arm group label: Intervention (Non ventilatory)
arm group type: Experimental
description: Breathing Exercise and Aerobic Training will be provided to all the patients.The training session will be given 3 days a week.
intervention type: Other
intervention name: Physical Exercises
description: Aerobic Training and Breathing Exercises.
arm group label: Intervention (Non ventilatory)
arm group label: Intervention Group (Ventilatory)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ishtiaq Ahmed, DPT
role: Principal Investigator
affiliation: Government College University
facility: 
country: Pakistan
citation: George PM, Wells AU, Jenkins RG. Pulmonary fibrosis and COVID-19: the potential role for antifibrotic therapy. Lancet Respir Med. 2020 Aug;8(8):807-815. doi: 10.1016/S2213-2600(20)30225-3. Epub 2020 May 15.
PMID: 32422178
citation: Belli S, Balbi B, Prince I, Cattaneo D, Masocco F, Zaccaria S, Bertalli L, Cattini F, Lomazzo A, Dal Negro F, Giardini M, Franssen FME, Janssen DJA, Spruit MA. Low physical functioning and impaired performance of activities of daily life in COVID-19 patients who survived hospitalisation. Eur Respir J. 2020 Oct 15;56(4):2002096. doi: 10.1183/13993003.02096-2020. Print 2020 Oct.
PMID: 32764112
responsible party type: Principal Investigator
investigator affiliation: Government College University Faisalabad
investigator full name: Ishtiaq Ahmed
investigator title: Physiotherapist
mesh term: COVID-19
sharing ipd: No