<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/NCT04402983</url>
  </required_header>
  <id_info>
    <org_study_id>Telerehab_Covid19</org_study_id>
    <nct_id>NCT04402983</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Telerehabilitation-Based Physiotherapy in COVID 19 Patients</brief_title>
  <official_title>The Effectiveness of Telerehabilitation-Based Physiotherapy in COVID 19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Medipol University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Medipol University Hospital</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>
      Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength&#xD;
      can be observed in individuals who have been diagnosed with COVID19 and have been discharged.&#xD;
      In our study, it was aimed to investigate the effect of telerehabilitation physical therapy&#xD;
      intervention to these cases by using videoconferencing method on the physical condition of&#xD;
      the cases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength&#xD;
      can be observed in individuals who have been diagnosed with COVID19 and have been discharged.&#xD;
      In our study, it was aimed to investigate the effect of telerehabilitation physical therapy&#xD;
      intervention to these cases by using videoconferencing method on the physical condition of&#xD;
      the cases. The exercise program will be a total of 6 weeks, 3 days a week. Online access will&#xD;
      be carried out synchronously by telephone or computer, and training sessions will not be&#xD;
      recorded in order to protect patient personal information. The cases will be evaluated online&#xD;
      at the beginning of the study and at the end of the 6-week exercise program. The selected&#xD;
      evaluation parameters have been selected considering the ease of online application.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2020</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</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>
    <intervention_model_description>Randomized controlled clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Medical Research Council Dyspnea Score</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>The mMRC Dyspnea Scale is best used to establish baseline functional impairment due to dyspnea attributable to respiratory disease; tracking the mMRC over time or with therapeutic interventions is of less certain clinical utility.The severity of dyspnea is rated on a scale of 0 to 4. &quot;O&quot; means no dyspnea perception, &quot;4&quot; means severe dyspnea perception.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed up and go test</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>The Timed &quot;Up and Go&quot; (TUG) Test measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down.&#xD;
Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more.&#xD;
Clinical guide: &lt;10 seconds = normal &lt;20 seconds = good mobility, can go out alone, mobile without a gait aid &lt;30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate high risk of falls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual analog scale to assess the pain severity</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>Visual analog scale to assess the pain on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Short Physical Performance Battery (SPPB)</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>The Short Physical Performance Battery (SPPB) is comprised of 3 tasks: a standing balance test (side by side, semi-tandem and tandem), a 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 points. The total score is 12 points and this represents the highest performance. It can be easily performed at home via video conferencing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual analog scale to assess the fatigue severity</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>Visual analog scale to assess the fatigue severity on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BECK depression inventory</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>This is a 21-item self-assessment scale designed by Aaron Beck in 1961 to measure the risk and level of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saint George Respiratory Questionnaire</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Covid19</condition>
  <condition>Telerehabilitation</condition>
  <condition>Physical Therapy</condition>
  <arm_group>
    <arm_group_label>Telerehabilitation Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physiotherapy will be carried out by conducting online conference method. Program content; Respiratory exercise (chest breathing, diaphragmatic breathing, basal expansion exercises), Breath control training, Active breathing techniques cycle Light aerobic exercise Posture exercises Self walking</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Information and exercise brochure will be provided</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiotherapy</intervention_name>
    <description>Program content Respiratory exercise (chest breathing, diaphragmatic breathing, basal expansion exercises), Breath control training, Active breathing techniques cycle Light aerobic exercise Posture exercises Self walking</description>
    <arm_group_label>Telerehabilitation Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being between the ages of 18-75&#xD;
&#xD;
          -  Being diagnosed with COVID19 and being discharged by being treated&#xD;
&#xD;
          -  Having technological facilities suitable for telerehabilitation access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any presence of comorbidity that may prevent them from exercising&#xD;
&#xD;
          -  Not agreeing to be included in the study&#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>Esra Pehlivan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saglik Bilimleri Universitesi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Health Sciences Turkey</name>
      <address>
        <city>İstanbul</city>
        <zip>34668</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>December 11, 2020</last_update_submitted>
  <last_update_submitted_qc>December 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saglik Bilimleri Universitesi</investigator_affiliation>
    <investigator_full_name>esra pehlivan</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>videoconference</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>Undecided</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/NCT04402983
org study id: Telerehab_Covid19
nct id: NCT04402983
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength
      can be observed in individuals who have been diagnosed with COVID19 and have been discharged.
      In our study, it was aimed to investigate the effect of telerehabilitation physical therapy
      intervention to these cases by using videoconferencing method on the physical condition of
      the cases.
Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength
      can be observed in individuals who have been diagnosed with COVID19 and have been discharged.
      In our study, it was aimed to investigate the effect of telerehabilitation physical therapy
      intervention to these cases by using videoconferencing method on the physical condition of
      the cases. The exercise program will be a total of 6 weeks, 3 days a week. Online access will
      be carried out synchronously by telephone or computer, and training sessions will not be
      recorded in order to protect patient personal information. The cases will be evaluated online
      at the beginning of the study and at the end of the 6-week exercise program. The selected
      evaluation parameters have been selected considering the ease of online application.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled clinical trial
primary purpose: Treatment
masking: None (Open Label)
measure: Modified Medical Research Council Dyspnea Score
time frame: Baseline to 6 weeks
description: The mMRC Dyspnea Scale is best used to establish baseline functional impairment due to dyspnea attributable to respiratory disease; tracking the mMRC over time or with therapeutic interventions is of less certain clinical utility.The severity of dyspnea is rated on a scale of 0 to 4. "O" means no dyspnea perception, "4" means severe dyspnea perception.
measure: Timed up and go test
time frame: Baseline to 6 weeks
description: The Timed "Up and Go" (TUG) Test measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down.
Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more.
Clinical guide: <10 seconds = normal <20 seconds = good mobility, can go out alone, mobile without a gait aid <30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate high risk of falls.
measure: Visual analog scale to assess the pain severity
time frame: Baseline to 6 weeks
description: Visual analog scale to assess the pain on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) score.
measure: The Short Physical Performance Battery (SPPB)
time frame: Baseline to 6 weeks
description: The Short Physical Performance Battery (SPPB) is comprised of 3 tasks: a standing balance test (side by side, semi-tandem and tandem), a 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 points. The total score is 12 points and this represents the highest performance. It can be easily performed at home via video conferencing
measure: Visual analog scale to assess the fatigue severity
time frame: Baseline to 6 weeks
description: Visual analog scale to assess the fatigue severity on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) score.
measure: BECK depression inventory
time frame: Baseline to 6 weeks
description: This is a 21-item self-assessment scale designed by Aaron Beck in 1961 to measure the risk and level of depression.
measure: Saint George Respiratory Questionnaire
time frame: Baseline to 6 weeks
description: The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)
arm group label: Telerehabilitation Group
arm group type: Experimental
description: Physiotherapy will be carried out by conducting online conference method. Program content; Respiratory exercise (chest breathing, diaphragmatic breathing, basal expansion exercises), Breath control training, Active breathing techniques cycle Light aerobic exercise Posture exercises Self walking
arm group label: Control group
arm group type: No Intervention
description: Information and exercise brochure will be provided
intervention type: Other
intervention name: Physiotherapy
description: Program content Respiratory exercise (chest breathing, diaphragmatic breathing, basal expansion exercises), Breath control training, Active breathing techniques cycle Light aerobic exercise Posture exercises Self walking
arm group label: Telerehabilitation Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Esra Pehlivan, PhD
role: Principal Investigator
affiliation: Saglik Bilimleri Universitesi
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Saglik Bilimleri Universitesi
investigator full name: esra pehlivan
investigator title: Principal investigator
mesh term: COVID-19
sharing ipd: Undecided