<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/NCT04473898</url>
  </required_header>
  <id_info>
    <org_study_id>KaratayU2</org_study_id>
    <nct_id>NCT04473898</nct_id>
  </id_info>
  <brief_title>Telerehabilitation After Coronavirus</brief_title>
  <official_title>Telerehabilitation After Covid-19: Effectiveness of Respiratory and Aerobic Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KTO Karatay University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KTO Karatay 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>
      The aim of the study is to investigate the effects of telerehabilitation program on COVID-19&#xD;
      symptoms, quality of life, level of depression, perception of dyspnea, sleep, fatigue,&#xD;
      kinesiophobia and patient satisfaction in individuals diagnosed with COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Because of the risk of infection, telerehabilitation applications are recommended for&#xD;
      patients with COVID-19. There are no studies in the literature evaluating the effectiveness&#xD;
      of telerehabilitation program after COVID-19. In particular, the importance of the first&#xD;
      eight weeks after the disease was emphasized.&#xD;
&#xD;
      It is thought that the telerehabilitation program will improve the functional capacities and&#xD;
      quality of life of patients in order to adapt to the daily life after the infection more&#xD;
      easily, to cope with the symptoms brought about by the disease more easily and to prevent the&#xD;
      respiratory distress, intensive care stay and inactivity due to muscle weakness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Actual">February 17, 2021</completion_date>
  <primary_completion_date type="Actual">October 19, 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>It is planned to include 3 groups in the study. The group 1 will be informed about covid-19 and hygiene. Aerobic exercise will be offered to Group 2, aerobic exercise + breathing exercises will be offered to Group 3. The persons to be included in the groups will be determined randomly.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dyspnoea</measure>
    <time_frame>baseline</time_frame>
    <description>It will be evaluated by the Modified Medical Research Council (mMRC). It consists of 5 items between 0 and 4. The increase in the score indicates the severity of dyspnea.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety and Depression</measure>
    <time_frame>baseline</time_frame>
    <description>It will be evaluated by the Hospital Anxiety and Depression Scale (HADS). The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately. Cut-off scores are available for quantification, for example a score of 8 or more for anxiety. The increase in the score indicates the severity of anxiety and depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>baseline</time_frame>
    <description>It will be evaluated by pittsburgh sleep quality index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>baseline</time_frame>
    <description>It will be evaluated by SF-36</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dyspnoea</measure>
    <time_frame>6 weeks later</time_frame>
    <description>It will be evaluated by the Modified Medical Research Council (mMRC). It will be evaluated by the Modified Medical Research Council (mMRC). It consists of 5 items between 0 and 4. The increase in the score indicates the severity of dyspnea.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety and Depression</measure>
    <time_frame>6 weeks later</time_frame>
    <description>It will be evaluated by the Hospital Anxiety and Depression Scale (HADS). The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately. Cut-off scores are available for quantification, for example a score of 8 or more for anxiety. The increase in the score indicates the severity of anxiety and depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>6 weeks later</time_frame>
    <description>It will be evaluated by pittsburgh sleep quality index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>6 weeks later</time_frame>
    <description>It will be evaluated by SF-36</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Kinesiophobia</measure>
    <time_frame>baseline</time_frame>
    <description>It will be evaluated by Kinesiophobia Causes Scale. The questionnaire consist of 20 closed questions, assessed in a range from 0 to 100 - a higher score indicating a higher fear of movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>6 weeks later</time_frame>
    <description>It will be evaluated by patient satisfaction scale. Likert scale questionnaire proposed seven dimensions of patient satisfaction directed toward their doctors. These are general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Increased score indicates decreased satisfaction. The minimum score is 18, the maximum score is 90.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>baseline</time_frame>
    <description>It will be evaluated by Fatigue Severity Scale. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinesiophobia</measure>
    <time_frame>6 weeks later</time_frame>
    <description>It will be evaluated by Kinesiophobia Causes Scale. The questionnaire consist of 20 closed questions, assessed in a range from 0 to 100 - a higher score indicating a higher fear of movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>6 weeks later</time_frame>
    <description>It will be evaluated by Fatigue Severity Scale. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Patient Education Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Information training about COViD-19 and its symptoms, hygiene education, family education</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aerobic Training Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Teaching and regular follow-up of aerobic exercises shown online</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aerobic + Respiratory Training Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Teaching and regular follow-up of aerobic and respiratory exercises shown online</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic Exercise Training</intervention_name>
    <description>Aerobic exercises using all body muscles and that one can do on their own after being shown online</description>
    <arm_group_label>Aerobic + Respiratory Training Group</arm_group_label>
    <arm_group_label>Aerobic Training Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient Education</intervention_name>
    <description>Patient education about covid-19 and hygiene education</description>
    <arm_group_label>Aerobic + Respiratory Training Group</arm_group_label>
    <arm_group_label>Aerobic Training Group</arm_group_label>
    <arm_group_label>Patient Education Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Respiratory Exercise Training</intervention_name>
    <description>Respiratory exercises that one can do on their own after being shown online</description>
    <arm_group_label>Aerobic + Respiratory Training Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  volunteering to participate in the study&#xD;
&#xD;
          -  at least once diagnosed with COVID-19,&#xD;
&#xD;
          -  has a cognitive level that can adapt to online exercises,&#xD;
&#xD;
          -  having a physical condition suitable for exercises&#xD;
&#xD;
          -  staying in hospital due to covid-19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refuse to participate in the study&#xD;
&#xD;
          -  having neurological, cardiac, respiratory disease that prevents exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Özlem Akkoyun Sert, Phd, PT</last_name>
    <role>Study Director</role>
    <affiliation>KTO Karatay University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kamil Yılmaz, Phd, PT</last_name>
    <role>Study Chair</role>
    <affiliation>KTO Karatay University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Osman Karaca, MsC,PT</last_name>
    <role>Study Chair</role>
    <affiliation>KTO Karatay University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hasan Gerçek, PT</last_name>
    <role>Study Chair</role>
    <affiliation>KTO Karatay University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bayram Sönmez Ünüvar, MsC, PT</last_name>
    <role>Study Chair</role>
    <affiliation>KTO Karatay University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sinan Bağçacı, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>KTO Karatay University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Büşra Alkan, MsC, PT, RA</last_name>
    <role>Study Chair</role>
    <affiliation>KTO Karatay University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Melike Akdam, PT, RA</last_name>
    <role>Study Chair</role>
    <affiliation>KTO Karatay University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Buse Kılınç, PT</last_name>
    <role>Study Chair</role>
    <affiliation>KTO Karatay University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KTO Karatay University</name>
      <address>
        <city>Konya</city>
        <state>Karatay</state>
        <zip>42030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>February 17, 2021</last_update_submitted>
  <last_update_submitted_qc>February 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Covid-19</keyword>
  <keyword>Telerehabilitation</keyword>
  <keyword>Respiratory Exercises</keyword>
  <keyword>Aerobic Exercises</keyword>
  <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/NCT04473898
org study id: KaratayU2
nct id: NCT04473898
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to investigate the effects of telerehabilitation program on COVID-19
      symptoms, quality of life, level of depression, perception of dyspnea, sleep, fatigue,
      kinesiophobia and patient satisfaction in individuals diagnosed with COVID-19.
Because of the risk of infection, telerehabilitation applications are recommended for
      patients with COVID-19. There are no studies in the literature evaluating the effectiveness
      of telerehabilitation program after COVID-19. In particular, the importance of the first
      eight weeks after the disease was emphasized.

      It is thought that the telerehabilitation program will improve the functional capacities and
      quality of life of patients in order to adapt to the daily life after the infection more
      easily, to cope with the symptoms brought about by the disease more easily and to prevent the
      respiratory distress, intensive care stay and inactivity due to muscle weakness.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: It is planned to include 3 groups in the study. The group 1 will be informed about covid-19 and hygiene. Aerobic exercise will be offered to Group 2, aerobic exercise + breathing exercises will be offered to Group 3. The persons to be included in the groups will be determined randomly.
primary purpose: Supportive Care
masking: Single (Participant)
measure: Dyspnoea
time frame: baseline
description: It will be evaluated by the Modified Medical Research Council (mMRC). It consists of 5 items between 0 and 4. The increase in the score indicates the severity of dyspnea.
measure: Anxiety and Depression
time frame: baseline
description: It will be evaluated by the Hospital Anxiety and Depression Scale (HADS). The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately. Cut-off scores are available for quantification, for example a score of 8 or more for anxiety. The increase in the score indicates the severity of anxiety and depression.
measure: Sleep Quality
time frame: baseline
description: It will be evaluated by pittsburgh sleep quality index
measure: Health Related Quality of Life
time frame: baseline
description: It will be evaluated by SF-36
measure: Dyspnoea
time frame: 6 weeks later
description: It will be evaluated by the Modified Medical Research Council (mMRC). It will be evaluated by the Modified Medical Research Council (mMRC). It consists of 5 items between 0 and 4. The increase in the score indicates the severity of dyspnea.
measure: Anxiety and Depression
time frame: 6 weeks later
description: It will be evaluated by the Hospital Anxiety and Depression Scale (HADS). The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately. Cut-off scores are available for quantification, for example a score of 8 or more for anxiety. The increase in the score indicates the severity of anxiety and depression.
measure: Sleep Quality
time frame: 6 weeks later
description: It will be evaluated by pittsburgh sleep quality index
measure: Health Related Quality of Life
time frame: 6 weeks later
description: It will be evaluated by SF-36
measure: Kinesiophobia
time frame: baseline
description: It will be evaluated by Kinesiophobia Causes Scale. The questionnaire consist of 20 closed questions, assessed in a range from 0 to 100 - a higher score indicating a higher fear of movement
measure: Patient Satisfaction
time frame: 6 weeks later
description: It will be evaluated by patient satisfaction scale. Likert scale questionnaire proposed seven dimensions of patient satisfaction directed toward their doctors. These are general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Increased score indicates decreased satisfaction. The minimum score is 18, the maximum score is 90.
measure: Fatigue
time frame: baseline
description: It will be evaluated by Fatigue Severity Scale. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63.
measure: Kinesiophobia
time frame: 6 weeks later
description: It will be evaluated by Kinesiophobia Causes Scale. The questionnaire consist of 20 closed questions, assessed in a range from 0 to 100 - a higher score indicating a higher fear of movement
measure: Fatigue
time frame: 6 weeks later
description: It will be evaluated by Fatigue Severity Scale. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63.
arm group label: Patient Education Group
arm group type: Sham Comparator
description: Information training about COViD-19 and its symptoms, hygiene education, family education
arm group label: Aerobic Training Group
arm group type: Experimental
description: Teaching and regular follow-up of aerobic exercises shown online
arm group label: Aerobic + Respiratory Training Group
arm group type: Experimental
description: Teaching and regular follow-up of aerobic and respiratory exercises shown online
intervention type: Other
intervention name: Aerobic Exercise Training
description: Aerobic exercises using all body muscles and that one can do on their own after being shown online
arm group label: Aerobic + Respiratory Training Group
arm group label: Aerobic Training Group
intervention type: Behavioral
intervention name: Patient Education
description: Patient education about covid-19 and hygiene education
arm group label: Aerobic + Respiratory Training Group
arm group label: Aerobic Training Group
arm group label: Patient Education Group
intervention type: Other
intervention name: Respiratory Exercise Training
description: Respiratory exercises that one can do on their own after being shown online
arm group label: Aerobic + Respiratory Training Group
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: No
last name: Özlem Akkoyun Sert, Phd, PT
role: Study Director
affiliation: KTO Karatay University
last name: Kamil Yılmaz, Phd, PT
role: Study Chair
affiliation: KTO Karatay University
last name: Osman Karaca, MsC,PT
role: Study Chair
affiliation: KTO Karatay University
last name: Hasan Gerçek, PT
role: Study Chair
affiliation: KTO Karatay University
last name: Bayram Sönmez Ünüvar, MsC, PT
role: Study Chair
affiliation: KTO Karatay University
last name: Sinan Bağçacı, Dr
role: Study Chair
affiliation: KTO Karatay University
last name: Büşra Alkan, MsC, PT, RA
role: Study Chair
affiliation: KTO Karatay University
last name: Melike Akdam, PT, RA
role: Study Chair
affiliation: KTO Karatay University
last name: Buse Kılınç, PT
role: Study Chair
affiliation: KTO Karatay University
facility: 
country: Turkey
responsible party type: Sponsor
sharing ipd: No