<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/NCT04455919</url>
  </required_header>
  <id_info>
    <org_study_id>PAP/RI2/2019_05</org_study_id>
    <secondary_id>2019-A01632-55</secondary_id>
    <nct_id>NCT04455919</nct_id>
  </id_info>
  <brief_title>Yoga for Chronic Chikungunya</brief_title>
  <acronym>YOCHIK</acronym>
  <official_title>Impact of Yoga on Quality of Life in Patients With Chronic Chikungunya: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Pointe-a-Pitre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Pointe-a-Pitre</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 purpose of this study is to assess the benefits of a 8-week yoga program on quality of&#xD;
      life in patients suffering from chronic chikungunya.&#xD;
&#xD;
      Studies have already shown the effectiveness of yoga practice on various arthralgia's, on the&#xD;
      reduction of inflammatory reactions, on psychological disorders/sleep disorders and on&#xD;
      quality of life. Considering quality of life as a global experience of balance between&#xD;
      physical and mental wellbeing, the hypothesis was that the practice of yoga would globally&#xD;
      improve the quality of life of patients with chronic chikungunya.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The chikungunya virus (CHIKV) is an arbovirus passed to humans by Aedes mosquitoes. Since its&#xD;
      description in 1952, CHIKV has caused millions of human infections in Africa, the Indian&#xD;
      Ocean islands, Asia, Europe and America (1). In total, since 2013, the epidemic has affected&#xD;
      more than 2 million people in the Americas. In Guadeloupe, the emergence of chikungunya cases&#xD;
      began in 2013. CHINKV was declared an epidemic in 2014 with an estimated 20,000 infected&#xD;
      patients.Human infection with CHIKV is characterized by a sudden onset of severe joint pains,&#xD;
      high fever and rash. The infection is self-limited and acute symptoms usually disappear&#xD;
      within one or two weeks. However, this polyarthralgia is recurrent in 30 to 40% of infected&#xD;
      people and can persist for years. Chikungunya is considered chronic if the symptoms persist&#xD;
      after three months. The chronic stage can last from a few months to several years. Chronic&#xD;
      chikungunya usually manifests as joint pain and stiffness, polyarthralgia (including&#xD;
      rheumatoid arthritis, flare-ups of spondylitis), and other general symptoms such as&#xD;
      intermittent headaches, edema, and paresthesia. The consequences of chronic CHIKV can be&#xD;
      severe, with patients becoming maladjusted to their lifestyle, feeling weakened and&#xD;
      diminished. Depression and medical leaves are very frequent, with many cases of disability.&#xD;
      Yoga is an ancestral Indian practice aiming to connect the &quot;body&quot; and the &quot;soul&quot;, the &quot;self&quot;&#xD;
      and &quot;the other&quot;. Traditionally, it is a philosophical way of living, sometimes combined with&#xD;
      the practice of physical exercises. In westernized countries, Yoga is usually considered as a&#xD;
      physical practice or an alternative therapy, using various techniques of breathing,&#xD;
      relaxation and poses to release tensions and decrease pain.&#xD;
&#xD;
      Studies have already shown the effectiveness of yoga practice on various arthralgia's, on the&#xD;
      reduction of inflammatory reactions, on psychological disorders/sleep disorders and on&#xD;
      quality of life. Considering quality of life as a global experience of balance between&#xD;
      physical and mental wellbeing, the hypothesis was that the practice of yoga, by improving&#xD;
      these different aspects, would globally improve the quality of life of patients with chronic&#xD;
      chikungunya.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    covid health crisis&#xD;
  </why_stopped>
  <start_date type="Actual">October 3, 2019</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 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 wait-list controlled design</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health Related Quality of Life - Short Form-36 (SF-36)</measure>
    <time_frame>At baseline</time_frame>
    <description>This scale measures eight health domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health) of quality of life for adults aged 18 and older. Using a scoring algorithm, the aggregated scores can provide two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Related Quality of Life - Short Form-36 (SF-36)</measure>
    <time_frame>after 8 weeks of intervention</time_frame>
    <description>This scale measures eight health domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health) of quality of life for adults aged 18 and older. Using a scoring algorithm, the aggregated scores can provide two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Related Quality of Life - Short Form-36 (SF-36)</measure>
    <time_frame>after 18 weeks</time_frame>
    <description>This scale measures eight health domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health) of quality of life for adults aged 18 and older. Using a scoring algorithm, the aggregated scores can provide two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>nociceptive pain - Visual Analog Scale (VAS)</measure>
    <time_frame>At baseline</time_frame>
    <description>The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. They can also be asked to mark their maximum, minimum, and average pain. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the &quot;no pain&quot; anchor point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nociceptive pain - Visual Analog Scale (VAS)</measure>
    <time_frame>after 8 weeks of intervention</time_frame>
    <description>The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. They can also be asked to mark their maximum, minimum, and average pain. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the &quot;no pain&quot; anchor point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nociceptive pain - Visual Analog Scale (VAS)</measure>
    <time_frame>after 18 weeks</time_frame>
    <description>The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. They can also be asked to mark their maximum, minimum, and average pain. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the &quot;no pain&quot; anchor point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neuropathic pain- DN4 scale</measure>
    <time_frame>At baseline</time_frame>
    <description>The total score is calculated as the sum of the 10 items and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neuropathic pain- DN4 scale</measure>
    <time_frame>after 8 weeks of intervention</time_frame>
    <description>The total score is calculated as the sum of the 10 items and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neuropathic pain- DN4 scale</measure>
    <time_frame>after 18 weeks</time_frame>
    <description>The total score is calculated as the sum of the 10 items and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Chikungunya Virus Infection</condition>
  <arm_group>
    <arm_group_label>Yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Yoga classes once a week for eight weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The delayed intervention group was to benefit from the intervention after week 8.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Wait-list group</intervention_name>
    <description>The wait-list group benefit from a 8-week yoga program after the interventional group</description>
    <arm_group_label>Wait-list control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Yoga group</intervention_name>
    <description>During 8 weeks, the intervention group attended weekly yoga sessions and had to practice poses at home</description>
    <arm_group_label>Yoga</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from chronic chikungunya, as documented by a positive chikungunya&#xD;
             serology and the following symptoms: polyarthralgia and/or musculoskeletal disorder&#xD;
             and/or morning stiffness.&#xD;
&#xD;
          -  Patients had to be between 18 and 70 years old, and be&#xD;
&#xD;
          -  patients affiliated to the French social insurance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  being pregnant;&#xD;
&#xD;
          -  suffering from pre-existing rheumatic diseases before the Chikungunya infection;&#xD;
&#xD;
          -  showing acute symptoms of a Chikungunya infection (documented serology);&#xD;
&#xD;
          -  being unable to practice yoga poses ; having been recently treated with methotrexate&#xD;
             or corticosteroids (less than 3 months ago);&#xD;
&#xD;
          -  being under guardianship, trusteeship or legal protection,&#xD;
&#xD;
          -  participating in another research study,&#xD;
&#xD;
          -  showing severely impaired physical and/or psychological health, which in the opinion&#xD;
             of the investigator, may affect the compliance of the study participant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mouffias' Medical Center in Guadeloupe.</name>
      <address>
        <city>Pointe-à-Pitre</city>
        <zip>97159</zip>
        <country>Guadeloupe</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Guadeloupe</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>chikungunya virus</keyword>
  <keyword>yoga</keyword>
  <keyword>chronic chikungunya</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chikungunya Fever</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/NCT04455919
org study id: PAP/RI2/2019_05
secondary id: 2019-A01632-55
nct id: NCT04455919
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the benefits of a 8-week yoga program on quality of
      life in patients suffering from chronic chikungunya.

      Studies have already shown the effectiveness of yoga practice on various arthralgia's, on the
      reduction of inflammatory reactions, on psychological disorders/sleep disorders and on
      quality of life. Considering quality of life as a global experience of balance between
      physical and mental wellbeing, the hypothesis was that the practice of yoga would globally
      improve the quality of life of patients with chronic chikungunya.
The chikungunya virus (CHIKV) is an arbovirus passed to humans by Aedes mosquitoes. Since its
      description in 1952, CHIKV has caused millions of human infections in Africa, the Indian
      Ocean islands, Asia, Europe and America (1). In total, since 2013, the epidemic has affected
      more than 2 million people in the Americas. In Guadeloupe, the emergence of chikungunya cases
      began in 2013. CHINKV was declared an epidemic in 2014 with an estimated 20,000 infected
      patients.Human infection with CHIKV is characterized by a sudden onset of severe joint pains,
      high fever and rash. The infection is self-limited and acute symptoms usually disappear
      within one or two weeks. However, this polyarthralgia is recurrent in 30 to 40% of infected
      people and can persist for years. Chikungunya is considered chronic if the symptoms persist
      after three months. The chronic stage can last from a few months to several years. Chronic
      chikungunya usually manifests as joint pain and stiffness, polyarthralgia (including
      rheumatoid arthritis, flare-ups of spondylitis), and other general symptoms such as
      intermittent headaches, edema, and paresthesia. The consequences of chronic CHIKV can be
      severe, with patients becoming maladjusted to their lifestyle, feeling weakened and
      diminished. Depression and medical leaves are very frequent, with many cases of disability.
      Yoga is an ancestral Indian practice aiming to connect the "body" and the "soul", the "self"
      and "the other". Traditionally, it is a philosophical way of living, sometimes combined with
      the practice of physical exercises. In westernized countries, Yoga is usually considered as a
      physical practice or an alternative therapy, using various techniques of breathing,
      relaxation and poses to release tensions and decrease pain.

      Studies have already shown the effectiveness of yoga practice on various arthralgia's, on the
      reduction of inflammatory reactions, on psychological disorders/sleep disorders and on
      quality of life. Considering quality of life as a global experience of balance between
      physical and mental wellbeing, the hypothesis was that the practice of yoga, by improving
      these different aspects, would globally improve the quality of life of patients with chronic
      chikungunya.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized wait-list controlled design
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Health Related Quality of Life - Short Form-36 (SF-36)
time frame: At baseline
description: This scale measures eight health domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health) of quality of life for adults aged 18 and older. Using a scoring algorithm, the aggregated scores can provide two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score.
measure: Health Related Quality of Life - Short Form-36 (SF-36)
time frame: after 8 weeks of intervention
description: This scale measures eight health domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health) of quality of life for adults aged 18 and older. Using a scoring algorithm, the aggregated scores can provide two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score.
measure: Health Related Quality of Life - Short Form-36 (SF-36)
time frame: after 18 weeks
description: This scale measures eight health domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health) of quality of life for adults aged 18 and older. Using a scoring algorithm, the aggregated scores can provide two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score.
measure: nociceptive pain - Visual Analog Scale (VAS)
time frame: At baseline
description: The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. They can also be asked to mark their maximum, minimum, and average pain. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no pain" anchor point.
measure: nociceptive pain - Visual Analog Scale (VAS)
time frame: after 8 weeks of intervention
description: The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. They can also be asked to mark their maximum, minimum, and average pain. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no pain" anchor point.
measure: nociceptive pain - Visual Analog Scale (VAS)
time frame: after 18 weeks
description: The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. They can also be asked to mark their maximum, minimum, and average pain. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no pain" anchor point.
measure: neuropathic pain- DN4 scale
time frame: At baseline
description: The total score is calculated as the sum of the 10 items and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.
measure: neuropathic pain- DN4 scale
time frame: after 8 weeks of intervention
description: The total score is calculated as the sum of the 10 items and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.
measure: neuropathic pain- DN4 scale
time frame: after 18 weeks
description: The total score is calculated as the sum of the 10 items and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.
arm group label: Yoga
arm group type: Experimental
description: Yoga classes once a week for eight weeks
arm group label: Wait-list control
arm group type: Other
description: The delayed intervention group was to benefit from the intervention after week 8.
intervention type: Other
intervention name: Wait-list group
description: The wait-list group benefit from a 8-week yoga program after the interventional group
arm group label: Wait-list control
intervention type: Other
intervention name: Yoga group
description: During 8 weeks, the intervention group attended weekly yoga sessions and had to practice poses at home
arm group label: Yoga
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Guadeloupe
responsible party type: Sponsor
mesh term: Chikungunya Fever
sharing ipd: No