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/NCT06008444</url>
    </required_header>
    <id_info>
      <org_study_id>Effects of COVID on Parkinson</org_study_id>
      <nct_id>NCT06008444</nct_id>
    </id_info>
    <brief_title>Chest Mobility, Strength, Physical Activity and Quality of Life in Parkinson's Patients With Post-COVID-19</brief_title>
    <official_title>Chest Mobility, Cough Strength, Muscle Strength, Physical Activity and Quality of Life in Parkinson's Patients Who Have Had COVID-19</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Izmir Democracy University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Izmir Democracy University</source>
    <oversight_info>
      <has_dmc>No</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>
        To comparative pain intensity, chest mobility, cough strength, muscle strength, physical&#xD;
        activity levels and quality of life in Parkinson's patients with post-COVID-19 and without&#xD;
        post-COVID-19 was aimed in current study. Knowledge in the literature regarding this topic is&#xD;
        still obscure.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Acute worsening and long-term sequelae of motor and non-motor symptoms have also been&#xD;
        described in Parkinson's patients during and after SARS-CoV-2 infection, which is also known&#xD;
        as prolonged COVID. The effects of COVID-19 on pain, chest mobility, cough strength, muscle&#xD;
        strength, physical activity levels and quality of life in Parkinson's patients are still&#xD;
        unclear today. For this reason, in this study, it was aimed to comparatively investigate&#xD;
        pain, chest mobility, cough strength, muscle strength, physical activity levels and quality&#xD;
        of life in Parkinson's patients with COVID-19 and without COVID-19 and to show the&#xD;
        relationships between these outcome measures.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Total quality of life score evaluated by Parkinson's Disease Questionnaire (PDQ-39) questionnaire.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The status of quality of life will be evaluated using Parkinson's Disease Questionnaire (PDQ-39) questionnaire. Parkinson's Disease Questionnaire-39 (PDQ39) is a 39-item quality of life questionnaire. Evaluation for each question item ranges from 0 (no problem) to 4 (constant problem). Low scores in total indicate an improvement in people's quality of life.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cough Strength</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Cough Strength will be evaluated using a Peak Flow Meter.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Daily average step count</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Daily average step counts will be recorded via a pedometer everyday within 3 days after confirming enrolment. All individuals will be asked to carry their pedometers with them during the day and record to their diaries.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hand grip strength</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Hand grip strength will be evaluated using a hand dynamometer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Chest mobility</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Chest mobility will be evaluated using a tape measure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive status</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Cognitive state will be evaluated using The mini-mental state examination (MMSE). It is an 11 question test. The highest score from the test is 30 points. Scores of 23 and lower indicate cognitive dysfunction, and scores of 24 and higher indicate normal cognitive level.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">32</enrollment>
    <condition>COVID-19 Respiratory Infection</condition>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Post-COVID-19 group</arm_group_label>
      <description>This group will consist of individuals with Parkinson disease who have had COVID-19.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>The control group will consist of individuals with Parkinson disease without post-COVID-19.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physical Evaluations of post-COVID-19 individuals</intervention_name>
      <description>In this research, the data of Parkinson's patients who have had COVID-19 will be collected face to face. Chest mobility, cough strength, muscle strength, physical activity and quality of life will be evaluated in all Parkinson's patients. The data to be obtained through all these evaluations will be collected from at one time and in a time lasting maximum of about 1 hour. Step count tracking with pedometer will be done for 3 days for each individual.</description>
      <arm_group_label>Post-COVID-19 group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physical Evaluations of non-post-COVID-19 individuals</intervention_name>
      <description>In this research, the data of Parkinson's patients who have not had COVID-19 will be collected face to face. Chest mobility, cough strength, muscle strength, physical activity and quality of life will be evaluated in all Parkinson's patients. The data to be obtained through all these evaluations will be collected from at one time and in a time lasting maximum of about 1 hour. Step count tracking with pedometer will be done for 3 days for each individual.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          At least 21 Parkinson's patients with post-COVID-19 will be included in the main group and&#xD;
          at least 11 Parkinson's patients without post-COVID-19 will be included in control group.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria for Parkinson's patients with post-COVID-19;&#xD;
  &#xD;
            -  Being diagnosed with COVID-19 at least 12 weeks ago and recovered,&#xD;
  &#xD;
            -  Being over 18 years old,&#xD;
  &#xD;
            -  Volunteering to participate in the research,&#xD;
  &#xD;
            -  Being diagnosed with Parkinson's disease&#xD;
  &#xD;
            -  Comorbid conditions (such as hypertension, diabetes) are under control&#xD;
  &#xD;
            -  Being able to perceive assessments (Standardized Mini Mental Test score of 24 and&#xD;
               above)&#xD;
  &#xD;
            -  Having the ability to ambulate and walk independently&#xD;
  &#xD;
            -  Being in stage 1 - 4 according to the Modified Hoehn-Yahr Scale&#xD;
  &#xD;
          Inclusion criteria for Parkinson's patients without post-COVID-19;&#xD;
  &#xD;
            -  Not being diagnosed or suspected of COVID-19&#xD;
  &#xD;
            -  Being over 18 years old,&#xD;
  &#xD;
            -  Volunteering to participate in the research,&#xD;
  &#xD;
            -  Being diagnosed with Parkinson's disease&#xD;
  &#xD;
            -  Having comorbid conditions (such as hypertension, diabetes) which are under control&#xD;
  &#xD;
            -  Being able to perceive assessments (Standardized Mini Mental Test score of 24 and&#xD;
               above)&#xD;
  &#xD;
            -  Having the ability to ambulate and walk independently&#xD;
  &#xD;
            -  Being in stage 1 - 4 according to the Modified Hoehn-Yahr Scale&#xD;
  &#xD;
          Exclusion criteria for Parkinson's patients with and without post-COVID-19;&#xD;
  &#xD;
            -  Sudden drug or dose change during the study period&#xD;
  &#xD;
            -  A history of any acute/chronic orthopedic, cardiovascular, pulmonary, psychiatric or&#xD;
               neuromuscular disease that may prevent measurements from being made.&#xD;
  &#xD;
            -  Having had myocardial infarction and pulmonary embolism in the last 30 days,&#xD;
  &#xD;
            -  Having a history of additional neurological (stroke, head trauma, peripheral nerve&#xD;
               diseases, brain and spinal cord tumors, etc.) diseases other than Parkinson's disease&#xD;
  &#xD;
            -  Having severe vision loss or vestibular dysfunction&#xD;
  &#xD;
            -  Patients with blood pressure values above 140/90 and below 90/50 in blood pressure&#xD;
               measurements made before the study, with arrhythmia on ECG, with a history of&#xD;
               shortness of breath and/or palpitation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>GÜLŞAH BARĞI</last_name>
      <role>Study Director</role>
      <affiliation>Izmir Democracy University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>MERVE ŞAHİN</last_name>
      <role>Principal Investigator</role>
      <affiliation>Izmir Democracy University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>ÖZLEM ÇİNAR ÖZDEMİR</last_name>
      <role>Principal Investigator</role>
      <affiliation>Izmir Democracy University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>YASEMİN ÜNAL</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bandirma Health Practice and Research Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>GÜLŞAH BARĞI</last_name>
      <phone>+90 232 299 0739</phone>
      <email>gulsahbargi35@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>MERVE ŞAHİN</last_name>
    </overall_contact_backup>
    <reference>
      <citation>Shalash A, Helmy A, Salama M, Gaber A, El-Belkimy M, Hamid E. A 6-month longitudinal study on worsening of Parkinson's disease during the COVID-19 pandemic. NPJ Parkinsons Dis. 2022 Aug 31;8(1):111. doi: 10.1038/s41531-022-00376-x.</citation>
      <PMID>36045133</PMID>
    </reference>
    <reference>
      <citation>Shalash A, Roushdy T, Essam M, Fathy M, Dawood NL, Abushady EM, Elrassas H, Helmi A, Hamid E. Mental Health, Physical Activity, and Quality of Life in Parkinson's Disease During COVID-19 Pandemic. Mov Disord. 2020 Jul;35(7):1097-1099. doi: 10.1002/mds.28134. Epub 2020 Jun 7. No abstract available.</citation>
      <PMID>32428342</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Izmir Democracy University</investigator_affiliation>
      <investigator_full_name>Gulsah Bargi</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>pain</keyword>
    <keyword>chest mobility</keyword>
    <keyword>cough</keyword>
    <keyword>muscle strength</keyword>
    <keyword>physical activity</keyword>
    <keyword>quality of life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Respiratory Tract Infections</mesh_term>
      <mesh_term>Parkinson Disease</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/NCT06008444
  org study id: Effects of COVID on Parkinson
  nct id: NCT06008444
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To comparative pain intensity, chest mobility, cough strength, muscle strength, physical
        activity levels and quality of life in Parkinson's patients with post-COVID-19 and without
        post-COVID-19 was aimed in current study. Knowledge in the literature regarding this topic is
        still obscure.
  Acute worsening and long-term sequelae of motor and non-motor symptoms have also been
        described in Parkinson's patients during and after SARS-CoV-2 infection, which is also known
        as prolonged COVID. The effects of COVID-19 on pain, chest mobility, cough strength, muscle
        strength, physical activity levels and quality of life in Parkinson's patients are still
        unclear today. For this reason, in this study, it was aimed to comparatively investigate
        pain, chest mobility, cough strength, muscle strength, physical activity levels and quality
        of life in Parkinson's patients with COVID-19 and without COVID-19 and to show the
        relationships between these outcome measures.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Total quality of life score evaluated by Parkinson's Disease Questionnaire (PDQ-39) questionnaire.
  time frame: through study completion, an average of 1 year
  description: The status of quality of life will be evaluated using Parkinson's Disease Questionnaire (PDQ-39) questionnaire. Parkinson's Disease Questionnaire-39 (PDQ39) is a 39-item quality of life questionnaire. Evaluation for each question item ranges from 0 (no problem) to 4 (constant problem). Low scores in total indicate an improvement in people's quality of life.
  measure: Cough Strength
  time frame: through study completion, an average of 1 year
  description: Cough Strength will be evaluated using a Peak Flow Meter.
  measure: Daily average step count
  time frame: through study completion, an average of 1 year
  description: Daily average step counts will be recorded via a pedometer everyday within 3 days after confirming enrolment. All individuals will be asked to carry their pedometers with them during the day and record to their diaries.
  measure: Hand grip strength
  time frame: through study completion, an average of 1 year
  description: Hand grip strength will be evaluated using a hand dynamometer.
  measure: Chest mobility
  time frame: through study completion, an average of 1 year
  description: Chest mobility will be evaluated using a tape measure.
  measure: Cognitive status
  time frame: through study completion, an average of 1 year
  description: Cognitive state will be evaluated using The mini-mental state examination (MMSE). It is an 11 question test. The highest score from the test is 30 points. Scores of 23 and lower indicate cognitive dysfunction, and scores of 24 and higher indicate normal cognitive level.
  arm group label: Post-COVID-19 group
  description: This group will consist of individuals with Parkinson disease who have had COVID-19.
  arm group label: Control group
  description: The control group will consist of individuals with Parkinson disease without post-COVID-19.
  intervention type: Other
  intervention name: Physical Evaluations of post-COVID-19 individuals
  description: In this research, the data of Parkinson's patients who have had COVID-19 will be collected face to face. Chest mobility, cough strength, muscle strength, physical activity and quality of life will be evaluated in all Parkinson's patients. The data to be obtained through all these evaluations will be collected from at one time and in a time lasting maximum of about 1 hour. Step count tracking with pedometer will be done for 3 days for each individual.
  arm group label: Post-COVID-19 group
  intervention type: Other
  intervention name: Physical Evaluations of non-post-COVID-19 individuals
  description: In this research, the data of Parkinson's patients who have not had COVID-19 will be collected face to face. Chest mobility, cough strength, muscle strength, physical activity and quality of life will be evaluated in all Parkinson's patients. The data to be obtained through all these evaluations will be collected from at one time and in a time lasting maximum of about 1 hour. Step count tracking with pedometer will be done for 3 days for each individual.
  arm group label: Control group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: GÜLŞAH BARĞI
  role: Study Director
  affiliation: Izmir Democracy University
  last name: MERVE ŞAHİN
  role: Principal Investigator
  affiliation: Izmir Democracy University
  last name: ÖZLEM ÇİNAR ÖZDEMİR
  role: Principal Investigator
  affiliation: Izmir Democracy University
  last name: YASEMİN ÜNAL
  role: Principal Investigator
  affiliation: Bandirma Health Practice and Research Hospital
  last name: GÜLŞAH BARĞI
  phone: +90 232 299 0739
  email: gulsahbargi35@gmail.com
  last name: MERVE ŞAHİN
  citation: Shalash A, Helmy A, Salama M, Gaber A, El-Belkimy M, Hamid E. A 6-month longitudinal study on worsening of Parkinson's disease during the COVID-19 pandemic. NPJ Parkinsons Dis. 2022 Aug 31;8(1):111. doi: 10.1038/s41531-022-00376-x.
  PMID: 36045133
  citation: Shalash A, Roushdy T, Essam M, Fathy M, Dawood NL, Abushady EM, Elrassas H, Helmi A, Hamid E. Mental Health, Physical Activity, and Quality of Life in Parkinson's Disease During COVID-19 Pandemic. Mov Disord. 2020 Jul;35(7):1097-1099. doi: 10.1002/mds.28134. Epub 2020 Jun 7. No abstract available.
  PMID: 32428342
  responsible party type: Principal Investigator
  investigator affiliation: Izmir Democracy University
  investigator full name: Gulsah Bargi
  investigator title: Principal Investigator
  mesh term: COVID-19
  mesh term: Respiratory Tract Infections
  mesh term: Parkinson Disease
  sharing ipd: No