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/NCT05973136</url>
    </required_header>
    <id_info>
      <org_study_id>2022-4665</org_study_id>
      <nct_id>NCT05973136</nct_id>
    </id_info>
    <brief_title>Telerehabilitation for Post COVID-19 Condition</brief_title>
    <acronym>Telecovie</acronym>
    <official_title>A Pilot Study to Evaluate the Implantation and the Impact of a Hybrid Telerehabilitation Program Based on Cardiopulmonary Rehabilitation Principles for People With Post-COVID Affection</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Université de Sherbrooke</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hotel Dieu Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Université de Sherbrooke</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>
        Telerehabilitation is a great alternative to offering care during a global pandemic. 85% of&#xD;
        patients with COVID-19 report persistent symptoms up to 8 months after the infection. There&#xD;
        are no clear recommendations for post-covid rehabilitation. The aims of the study are (1) to&#xD;
        test the logistic aspect of implanting a hybrid rehabilitation program and (2) to evaluate&#xD;
        the acceptability and the potential impact of the program on treating patients with&#xD;
        functional limitations and persistent fatigue symptoms. It's a pre and post-study without a&#xD;
        control group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Telerehabilitation is a great alternative to offering care during a global pandemic. 85% of&#xD;
        patients with COVID-19 report persistent symptoms up to 8 months after the infection. There&#xD;
        are no clear recommendations for post-covid rehabilitation. The aims of the study are (1) to&#xD;
        test the logistic aspect of implanting a hybrid rehabilitation program and (2) to evaluate&#xD;
        the acceptability and the potential impact of the program on treating patients with&#xD;
        functional limitations and persistent fatigue symptoms. It's a pre and post-study without a&#xD;
        control group. The intervention will be based on cardiopulmonary rehabilitation principles&#xD;
        and will be administered for 12 weeks. Fatigue, post-exertional malaise, and&#xD;
        functional/exercise capacities will be evaluated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2022</start_date>
    <completion_date type="Actual">August 8, 2022</completion_date>
    <primary_completion_date type="Actual">August 8, 2022</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 design is a pre-post without a control group</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The feasibility of the program</measure>
      <time_frame>12 weeks</time_frame>
      <description>This will be evaluated by % of participants that accept to participate in the study (recruitment rate), % who completed the intervention (retention rate) and % completed session/anticipated session (adherence).&#xD;
  The security of the program will be evaluated by the number of falls or near fall.&#xD;
  Technical difficulty</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability</measure>
      <time_frame>12 weeks</time_frame>
      <description>The satisfaction of the participants will be evaluated with a questionnaire (14 questions). The questionnaire will assess patients' satisfaction with the professional, the services and the organization - Telemedicine Satisfaction. Qualitative open-ended questions will be used to determine appreciation and challenges encountered.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fatigue and post-exercise malaise</measure>
      <time_frame>12 weeks</time_frame>
      <description>This will be evaluated with the Fatigue severity scare and De Paul Symptom Questionnaire.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Heart rate variability (resting)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Measured with the POLAR H10</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional capacity</measure>
      <time_frame>12 weeks</time_frame>
      <description>Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire (SARC-F)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exercise capacity</measure>
      <time_frame>12 weeks</time_frame>
      <description>6-minute walk test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lower-limb endurance (estimated)</measure>
      <time_frame>12 weeks</time_frame>
      <description>1-minute sit-to-stand test</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">7</enrollment>
    <condition>Long COVID</condition>
    <condition>Chronic Fatigue Syndrome</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group of participant receiving the hybrid telerehabilitation intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Telerehabilitation program based on cardiorespiratory principles</intervention_name>
      <description>The intervention consists of a hybrid program. The participant will receive rehabilitation sessions in presence (aerobic component of the intervention based on maximal oxygen uptake measured before intervention by means on a ergospirometric test) and at home via a telerehabilitation platform. The length of the intervention is 12 weeks. For the in-presence sessions, they are going to be 75 minutes, 2x/week. For the at-distance sessions, they are going to be 45 minutes, 1x/week in groups of 3 to 4 participants. The intervention will consist of a warm-up, endurance, postural, and strengthening exercises, cool down and respiratory exercises. An exercise book with final recommendations is provided to the participants at the end of the intervention.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Living in the community&#xD;
  &#xD;
            -  Living near Sherbrooke (&lt;50km)&#xD;
  &#xD;
            -  Having a diagnostic of COVID-19 confirmed (PCR) and post-COVID syndrome (according to&#xD;
               the World Health Organization criteria)&#xD;
  &#xD;
            -  Being aged between 25 and 65 years old&#xD;
  &#xD;
            -  Having access to internet at home&#xD;
  &#xD;
            -  Living with a family member/caregiver or having a telephone or a medical alert system&#xD;
               (in case of emergency)&#xD;
  &#xD;
            -  Reporting persistent fatigue symptoms according to the Fatigue Severity Scale (FSS)&#xD;
               (score≥4/7)&#xD;
  &#xD;
            -  Reporting functional limitations according to the Post-COVID-19 Functional Status&#xD;
               scale (PCFS (score ≥2/4);&#xD;
  &#xD;
            -  Being able to give free and informed consent (adequate understanding of the study&#xD;
               protocol);&#xD;
  &#xD;
            -  Agreeing to perform a pulmonary function test, an exercise stress test, and an&#xD;
               ergospirometric exercise test (adequate understanding of steps and procedures);&#xD;
  &#xD;
            -  Having a low exercise capacity and moderate-to-severe cardiovascular risk &lt;7 metabolic&#xD;
               equivalent of a task (MET) or ≤9 if significant reduction of self-reported exercise&#xD;
               tolerance according to the stress test performed on a treadmill - Cornell protocol);&#xD;
  &#xD;
            -  Having no other potential explanatory causes for fatigue or reduced exercise capacity&#xD;
               according to medical evaluation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cognitive impairment: Mini-Mental State Examination (MMSE) ≤24/30&#xD;
  &#xD;
            -  Inability to perform or understand study procedures&#xD;
  &#xD;
            -  Medical contraindication&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Livia Pinheiro Carvalho, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Université de Sherbrooke</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Université de Sherbrooke</name>
        <address>
          <city>Sherbrooke</city>
          <state>Quebec</state>
          <zip>J1H 5N4</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>cardiorespiratory</keyword>
    <keyword>exercise</keyword>
    <keyword>virtual rehabilitation</keyword>
    <keyword>post COVID-19 syndrome</keyword>
    <keyword>fatigue</keyword>
    <keyword>physiotherapy</keyword>
    <keyword>post-COVID affection</keyword>
    <keyword>post-COVID condition</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Post-Acute COVID-19 Syndrome</mesh_term>
      <mesh_term>Fatigue Syndrome, Chronic</mesh_term>
      <mesh_term>Fatigue</mesh_term>
    </condition_browse>
    <!-- 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/NCT05973136
  org study id: 2022-4665
  nct id: NCT05973136
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Telerehabilitation is a great alternative to offering care during a global pandemic. 85% of
        patients with COVID-19 report persistent symptoms up to 8 months after the infection. There
        are no clear recommendations for post-covid rehabilitation. The aims of the study are (1) to
        test the logistic aspect of implanting a hybrid rehabilitation program and (2) to evaluate
        the acceptability and the potential impact of the program on treating patients with
        functional limitations and persistent fatigue symptoms. It's a pre and post-study without a
        control group.
  Telerehabilitation is a great alternative to offering care during a global pandemic. 85% of
        patients with COVID-19 report persistent symptoms up to 8 months after the infection. There
        are no clear recommendations for post-covid rehabilitation. The aims of the study are (1) to
        test the logistic aspect of implanting a hybrid rehabilitation program and (2) to evaluate
        the acceptability and the potential impact of the program on treating patients with
        functional limitations and persistent fatigue symptoms. It's a pre and post-study without a
        control group. The intervention will be based on cardiopulmonary rehabilitation principles
        and will be administered for 12 weeks. Fatigue, post-exertional malaise, and
        functional/exercise capacities will be evaluated.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The study design is a pre-post without a control group
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The feasibility of the program
  time frame: 12 weeks
  description: This will be evaluated by % of participants that accept to participate in the study (recruitment rate), % who completed the intervention (retention rate) and % completed session/anticipated session (adherence).
  The security of the program will be evaluated by the number of falls or near fall.
  Technical difficulty
  measure: Acceptability
  time frame: 12 weeks
  description: The satisfaction of the participants will be evaluated with a questionnaire (14 questions). The questionnaire will assess patients' satisfaction with the professional, the services and the organization - Telemedicine Satisfaction. Qualitative open-ended questions will be used to determine appreciation and challenges encountered.
  measure: Fatigue and post-exercise malaise
  time frame: 12 weeks
  description: This will be evaluated with the Fatigue severity scare and De Paul Symptom Questionnaire.
  measure: Heart rate variability (resting)
  time frame: 12 weeks
  description: Measured with the POLAR H10
  measure: Functional capacity
  time frame: 12 weeks
  description: Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire (SARC-F)
  measure: Exercise capacity
  time frame: 12 weeks
  description: 6-minute walk test
  measure: Lower-limb endurance (estimated)
  time frame: 12 weeks
  description: 1-minute sit-to-stand test
  arm group label: Intervention group
  arm group type: Experimental
  description: Group of participant receiving the hybrid telerehabilitation intervention
  intervention type: Other
  intervention name: Telerehabilitation program based on cardiorespiratory principles
  description: The intervention consists of a hybrid program. The participant will receive rehabilitation sessions in presence (aerobic component of the intervention based on maximal oxygen uptake measured before intervention by means on a ergospirometric test) and at home via a telerehabilitation platform. The length of the intervention is 12 weeks. For the in-presence sessions, they are going to be 75 minutes, 2x/week. For the at-distance sessions, they are going to be 45 minutes, 1x/week in groups of 3 to 4 participants. The intervention will consist of a warm-up, endurance, postural, and strengthening exercises, cool down and respiratory exercises. An exercise book with final recommendations is provided to the participants at the end of the intervention.
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Livia Pinheiro Carvalho, PhD
  role: Principal Investigator
  affiliation: Université de Sherbrooke
  facility: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Post-Acute COVID-19 Syndrome
  mesh term: Fatigue Syndrome, Chronic
  mesh term: Fatigue