<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/NCT04491396</url>
  </required_header>
  <id_info>
    <org_study_id>12771</org_study_id>
    <nct_id>NCT04491396</nct_id>
  </id_info>
  <brief_title>Yoga Adjunct for Scleroderma</brief_title>
  <acronym>GYYB</acronym>
  <official_title>Assessing a Gentle Yoga Combined With Yoga Breathing (GYYB) Adjunct Intervention for Scleroderma Self-Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Richard Silver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Marvella Ford</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Paul Nietert</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Therese Killeen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of South Carolina</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>
      This is a pilot research study to determine the feasibility of gentle yoga and breathing&#xD;
      exercises for symptom management in patients with scleroderma. Participants will have a first&#xD;
      study visit that includes completing demographic and quality-of-life surveys, learning the&#xD;
      gentle yoga and breathing exercises, and providing two saliva samples before and after doing&#xD;
      the exercises. After this visit, participants will do the gentle yoga and breathing exercises&#xD;
      twice daily at home (morning and evening) by following a video hyperlink. Participants will&#xD;
      make an entry in their Yoga Practice Diaries each time they practice at home. On the 12th&#xD;
      Week, participants will return to MUSC for a final study visit that includes doing the gentle&#xD;
      yoga and breathing exercises, providing saliva samples, and completing a satisfaction survey.&#xD;
      There will be a total of 2 clinic visits (on Weeks 1 and 12). The study coordinator will&#xD;
      telephone participants weekly during the 10 weeks that they do the gentle yoga and breathing&#xD;
      exercises at home to answer questions and help solve any problems. Each visit will take about&#xD;
      2 hours for this research study, in addition to any routine clinical examinations. Each home&#xD;
      yoga and breathing practice will take 1 hour. The total study duration is 12 Weeks (3&#xD;
      months). Participants will receive compensation for their travel in the form of prepaid Visa&#xD;
      gift cards.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot research project will:&#xD;
&#xD;
        -  Test the feasibility of a scleroderma self-management intervention that combines Gentle&#xD;
           Yoga postures and Yoga Breathing (GYYB) as adjunctive treatment with standard care.&#xD;
&#xD;
        -  Explore the effectiveness of GYYB for improving health-related quality-of-life (QoL)&#xD;
           outcomes.&#xD;
&#xD;
        -  Provide information about acceptance and adoption of a GYYB intervention by scleroderma&#xD;
           patients of African ancestry (AA) and non-Hispanic white (NHW) scleroderma patients in&#xD;
           the United States (US).&#xD;
&#xD;
        -  Investigate, for the first time in scleroderma patients, the relationship between GYYB&#xD;
           and inflammatory biomarker changes which may provide insight into biological changes&#xD;
           associated with improved health-related QoL outcomes.&#xD;
&#xD;
      The following specific aims will be examined in a Pre/Post design using a 12-week GYYB&#xD;
      intervention as an adjunct self-management strategy along with usual care:&#xD;
&#xD;
      Specific Aim 1: Conduct a feasibility trial to assess changes in self-reported QoL in a&#xD;
      12-week adjunct GYYB program among scleroderma patients (N=30) receiving usual care. Outcomes&#xD;
      will be assessed in the overall study population and stratified by race/ethnicity (NHW vs.&#xD;
      AA).&#xD;
&#xD;
      Specific Aim 2: Assess changes in the expression of inflammatory biomarkers in a 12-week&#xD;
      adjunct GYYB program in scleroderma patients receiving usual care. Outcomes will be assessed&#xD;
      in the overall study population and stratified by race/ethnicity (NHW vs. AA).&#xD;
&#xD;
      This is a pilot study and will not test a hypothesis. There are no preliminary data for&#xD;
      making assumptions regarding effect sizes and variability between Pre/Post measures in this&#xD;
      intervention. The main goal of this pilot study is estimation.&#xD;
&#xD;
      Results will provide critical preliminary data for planning a larger study and information&#xD;
      about differences (or lack thereof) by race/ethnicity. With N=30 patients overall (n=15 per&#xD;
      race/ethnicity group), investigators will be able to obtain relatively precise estimates of&#xD;
      completion rates (e.g., 95% confidence intervals extending ±14% for the entire group and&#xD;
      extending ±20% for each race/ethnicity group). Assuming some drop-outs over the study (i.e.,&#xD;
      with n=26 completers), investigators will be able to estimate changes in expression of&#xD;
      inflammatory biomarkers with adequate precision (e.g., 95% confidence intervals extending&#xD;
      ±0.4 standard deviation units for the entire group and extending ±0.5 standard deviation&#xD;
      units for each race/ethnicity group). Although hypothesis testing is secondary, note that&#xD;
      this study will have 80% power to detect changes equivalent to 0.6 standard deviation units&#xD;
      in the overall sample and 0.8 standard deviation units in each race/ethnicity group (NHW and&#xD;
      AA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 8, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>Mixed methods model</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The study is not blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life determination: SHAQ-DI</measure>
    <time_frame>12 weeks</time_frame>
    <description>Scleroderma Health Assessment Questionnaire and Disability Index (SHAQ-DI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived Stress</measure>
    <time_frame>12 weeks</time_frame>
    <description>Perceived Stress Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression</measure>
    <time_frame>12 weeks</time_frame>
    <description>10-item Center for Epidemiologic Studies Depression Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Salivary biomarkers</measure>
    <time_frame>Weeks 0 and 12</time_frame>
    <description>IL-1β, IL-8 , IL-6, and MCP-1, and cortisol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility test</measure>
    <time_frame>Week 12</time_frame>
    <description>enrollment data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence</measure>
    <time_frame>12 weeks</time_frame>
    <description>Practice diary</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptance</measure>
    <time_frame>12 weeks</time_frame>
    <description>Satisfaction using likert scale</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Scleroderma</condition>
  <arm_group>
    <arm_group_label>GYYB</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This is a single-arm pre-post design.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Gentle Yoga and Yogic Breathing</intervention_name>
    <description>Gentle Yoga (GY) postures can be done while seated on a chair (sometimes called &quot;Chair Yoga&quot;) and have been shown to benefit people with symptoms associated with cancer.12 However, Yoga is under-studied in the area of scleroderma. While most traditional Yoga postures can be practiced by anyone, people with scleroderma often have limited physical movement and can be prone to injury. Gentle Yoga postures are physically much easier to do than traditional Yoga and, thus, may be more accessible for SSc patients with musculoskeletal and other impairments. Gentle Yoga postures that are done while seated on a chair also combine easily with YB, but little is known about the specific benefits of the GY+YB combination (GYYB). Further study is needed to determine whether GYYB may be an effective strategy for improving QoL in SSc patients. The Yoga intervention to be used in this study specifically involves GY done while seated in combination with YB.</description>
    <arm_group_label>GYYB</arm_group_label>
    <other_name>Chair Yoga and Pranayama</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women fulfilling the 2013 ACR/EULAR Classification for Systemic Sclerosis&#xD;
&#xD;
          -  Self-identified race/ethnicity as AA or NHW&#xD;
&#xD;
          -  Undergoing treatment from any healthcare provider&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Ability to perform the study exercises involving gentle movements sitting on a chair&#xD;
             and regulated breathing&#xD;
&#xD;
          -  Access to a working telephone&#xD;
&#xD;
          -  Access to watch a video from a DVD or from a website or Youtube&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with psychiatric or cognitive disorder that precludes provision of written&#xD;
             informed consent&#xD;
&#xD;
          -  Physical limitations making Yoga techniques detrimental&#xD;
&#xD;
          -  Enrolled in any other Yoga related clinical trials&#xD;
&#xD;
          -  Currently engaged in regular Yoga activity (once per week or more).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 17, 2023</last_update_submitted>
  <last_update_submitted_qc>July 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Sundaravadivel Balasubramanian</investigator_full_name>
    <investigator_title>Assistant Professor Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Scleroderma, Localized</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Non-identifiable study results will be shared with the patient and scientific community.</ipd_description>
  </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/NCT04491396
org study id: 12771
nct id: NCT04491396
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a pilot research study to determine the feasibility of gentle yoga and breathing
      exercises for symptom management in patients with scleroderma. Participants will have a first
      study visit that includes completing demographic and quality-of-life surveys, learning the
      gentle yoga and breathing exercises, and providing two saliva samples before and after doing
      the exercises. After this visit, participants will do the gentle yoga and breathing exercises
      twice daily at home (morning and evening) by following a video hyperlink. Participants will
      make an entry in their Yoga Practice Diaries each time they practice at home. On the 12th
      Week, participants will return to MUSC for a final study visit that includes doing the gentle
      yoga and breathing exercises, providing saliva samples, and completing a satisfaction survey.
      There will be a total of 2 clinic visits (on Weeks 1 and 12). The study coordinator will
      telephone participants weekly during the 10 weeks that they do the gentle yoga and breathing
      exercises at home to answer questions and help solve any problems. Each visit will take about
      2 hours for this research study, in addition to any routine clinical examinations. Each home
      yoga and breathing practice will take 1 hour. The total study duration is 12 Weeks (3
      months). Participants will receive compensation for their travel in the form of prepaid Visa
      gift cards.
This pilot research project will:

        -  Test the feasibility of a scleroderma self-management intervention that combines Gentle
           Yoga postures and Yoga Breathing (GYYB) as adjunctive treatment with standard care.

        -  Explore the effectiveness of GYYB for improving health-related quality-of-life (QoL)
           outcomes.

        -  Provide information about acceptance and adoption of a GYYB intervention by scleroderma
           patients of African ancestry (AA) and non-Hispanic white (NHW) scleroderma patients in
           the United States (US).

        -  Investigate, for the first time in scleroderma patients, the relationship between GYYB
           and inflammatory biomarker changes which may provide insight into biological changes
           associated with improved health-related QoL outcomes.

      The following specific aims will be examined in a Pre/Post design using a 12-week GYYB
      intervention as an adjunct self-management strategy along with usual care:

      Specific Aim 1: Conduct a feasibility trial to assess changes in self-reported QoL in a
      12-week adjunct GYYB program among scleroderma patients (N=30) receiving usual care. Outcomes
      will be assessed in the overall study population and stratified by race/ethnicity (NHW vs.
      AA).

      Specific Aim 2: Assess changes in the expression of inflammatory biomarkers in a 12-week
      adjunct GYYB program in scleroderma patients receiving usual care. Outcomes will be assessed
      in the overall study population and stratified by race/ethnicity (NHW vs. AA).

      This is a pilot study and will not test a hypothesis. There are no preliminary data for
      making assumptions regarding effect sizes and variability between Pre/Post measures in this
      intervention. The main goal of this pilot study is estimation.

      Results will provide critical preliminary data for planning a larger study and information
      about differences (or lack thereof) by race/ethnicity. With N=30 patients overall (n=15 per
      race/ethnicity group), investigators will be able to obtain relatively precise estimates of
      completion rates (e.g., 95% confidence intervals extending ±14% for the entire group and
      extending ±20% for each race/ethnicity group). Assuming some drop-outs over the study (i.e.,
      with n=26 completers), investigators will be able to estimate changes in expression of
      inflammatory biomarkers with adequate precision (e.g., 95% confidence intervals extending
      ±0.4 standard deviation units for the entire group and extending ±0.5 standard deviation
      units for each race/ethnicity group). Although hypothesis testing is secondary, note that
      this study will have 80% power to detect changes equivalent to 0.6 standard deviation units
      in the overall sample and 0.8 standard deviation units in each race/ethnicity group (NHW and
      AA).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Mixed methods model
primary purpose: Treatment
masking: None (Open Label)
masking description: The study is not blinded.
measure: Quality of life determination: SHAQ-DI
time frame: 12 weeks
description: Scleroderma Health Assessment Questionnaire and Disability Index (SHAQ-DI)
measure: Perceived Stress
time frame: 12 weeks
description: Perceived Stress Scale
measure: Depression
time frame: 12 weeks
description: 10-item Center for Epidemiologic Studies Depression Scale
measure: Salivary biomarkers
time frame: Weeks 0 and 12
description: IL-1β, IL-8 , IL-6, and MCP-1, and cortisol
measure: Feasibility test
time frame: Week 12
description: enrollment data
measure: Adherence
time frame: 12 weeks
description: Practice diary
measure: Acceptance
time frame: 12 weeks
description: Satisfaction using likert scale
arm group label: GYYB
arm group type: Other
description: This is a single-arm pre-post design.
intervention type: Behavioral
intervention name: Gentle Yoga and Yogic Breathing
description: Gentle Yoga (GY) postures can be done while seated on a chair (sometimes called "Chair Yoga") and have been shown to benefit people with symptoms associated with cancer.12 However, Yoga is under-studied in the area of scleroderma. While most traditional Yoga postures can be practiced by anyone, people with scleroderma often have limited physical movement and can be prone to injury. Gentle Yoga postures are physically much easier to do than traditional Yoga and, thus, may be more accessible for SSc patients with musculoskeletal and other impairments. Gentle Yoga postures that are done while seated on a chair also combine easily with YB, but little is known about the specific benefits of the GY+YB combination (GYYB). Further study is needed to determine whether GYYB may be an effective strategy for improving QoL in SSc patients. The Yoga intervention to be used in this study specifically involves GY done while seated in combination with YB.
arm group label: GYYB
other name: Chair Yoga and Pranayama
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Sundaravadivel Balasubramanian
investigator title: Assistant Professor Research
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Scleroderma, Localized
sharing ipd: Undecided
ipd description: Non-identifiable study results will be shared with the patient and scientific community.