<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/NCT03840525</url>
  </required_header>
  <id_info>
    <org_study_id>1R34AT009966-01</org_study_id>
    <nct_id>NCT03840525</nct_id>
  </id_info>
  <brief_title>A Mind Body Intervention to Reduce Symptoms Among People Aging With HIV</brief_title>
  <official_title>A Mind Body Intervention to Reduce Symptoms Among People Aging With HIV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida International University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Florida International University</source>
  <oversight_info>
    <has_dmc>Yes</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 study will develop and pilot test a qigong intervention with older people (50 and over)&#xD;
      living with HIV. Participants (n=72) will be randomly assigned to one of 3 conditions: the&#xD;
      qigong intervention, a sham qigong intervention, and a usual standard of care group. The&#xD;
      study will determine the acceptability and feasibility of the study. If found effective, the&#xD;
      qigong intervention will also improve the psychological and physical symptoms of older people&#xD;
      living with HIV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Half of those infected with HIV in the United States are over 50 years of age; this is&#xD;
      expected to increase to 70% by 2020. Yet, few interventions exist for older people living&#xD;
      with HIV/AIDS that address psychological symptoms, and none that address physical symptoms,&#xD;
      both of which are prevalent in this population. There is a need to find innovative and&#xD;
      accessible interventions that can help older people living with HIV/AIDS to manage their&#xD;
      symptoms. Mind-body interventions, like Tai chi and Qi gong (TCQ), improves both physical and&#xD;
      psychological health, and might also promote immune functioning. TCQ is a series of slow,&#xD;
      low-impact meditative movements that integrates breath work, meditation, and stances. The&#xD;
      investigators propose the refinement, adaptation, acceptability and feasibility testing of a&#xD;
      standardized TCQ intervention shown efficacious with cancer patients, to an ethnically&#xD;
      diverse population of older people living with HIV/AIDS, with the goal of enhancing their&#xD;
      ability to manage psychological and physical symptoms. Thus, this study proposes three aims:&#xD;
      (i) to refine and culturally adapt a TCQ intervention protocol for a diverse sample of older&#xD;
      people living with HIV/AIDS (50 years of age or older); (ii) to evaluate the acceptability&#xD;
      and feasibility of the TCQ intervention, a sham qigong control condition, and a standard of&#xD;
      care control condition for older people living with HIV/AIDS (n = 60); and (iii) explore any&#xD;
      preliminary evidence of efficacy of the TCQ intervention and the control conditions on&#xD;
      alleviating physical and psychological symptoms. Participants will be recruited from a&#xD;
      federally qualified health center in Miami, Florida. Adaptation of the TCQ intervention, the&#xD;
      first aim, will be done through qualitative research. An expert panel discussion, key&#xD;
      informant interviews, and three focus groups will be conducted, and analyzed by thematically&#xD;
      based content analysis. To address aims 2 and 3, the investigators will conduct a pilot&#xD;
      study; participants will be randomized to one of 3 conditions: the TCQ intervention, a sham&#xD;
      qigong condition, and a standard of care condition. This is a pilot study to assess&#xD;
      feasibility, acceptability, and preliminary efficacy, therefore, analyses will be primarily&#xD;
      descriptive. The investigators will assess feasibility and acceptability through&#xD;
      questionnaires and adherence to TCQ. The investigators will assess preliminary evidence of&#xD;
      efficacy by looking at instruments that measure depression, anxiety, social support, as well&#xD;
      as clinical outcomes. These will be described through proportions, means, and changes over&#xD;
      time through graphing techniques. Outcomes will be assessed at baseline, post-intervention,&#xD;
      and at three months follow up. The investigators will conduct preliminary models that will&#xD;
      provide information on estimating effect size and power needed for a larger clinical trial.&#xD;
      Note: Due to the coronavirus pandemic, this intervention was adapted from an in-person&#xD;
      intervention to a virtual intervention. The intervention is exactly the same except for the&#xD;
      difference in delivery method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2020</start_date>
  <completion_date type="Actual">September 30, 2022</completion_date>
  <primary_completion_date type="Actual">September 30, 2022</primary_completion_date>
  <phase>Early Phase 1</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>The study will implement a 3 arm study including the qigong intervention, sham qigong intervention, and a treatment as usual condition. The qigong and sham qigong groups will be delivered virtually due to the coronavirus pandemic.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>There will be a sham qigong arm of the study to mask qigong participation for the participants</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Satisfaction with weekly Intervention Sessions</measure>
    <time_frame>Assessments will be conducted once in Week 1</time_frame>
    <description>Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly Intervention Sessions</measure>
    <time_frame>Assessments will be conducted once in Week 2</time_frame>
    <description>Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly Intervention Sessions</measure>
    <time_frame>Assessments will be conducted once in Week 3</time_frame>
    <description>Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly Intervention Sessions</measure>
    <time_frame>Assessments will be conducted once in Week 4</time_frame>
    <description>Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly Intervention Sessions</measure>
    <time_frame>Assessments will be conducted once in Week 5</time_frame>
    <description>Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly Intervention Sessions</measure>
    <time_frame>Assessments will be conducted once in Week 6</time_frame>
    <description>Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly Intervention Sessions</measure>
    <time_frame>Assessments will be conducted once in Week 7</time_frame>
    <description>Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly Intervention Sessions</measure>
    <time_frame>Assessments will be conducted once in Week 8</time_frame>
    <description>Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly Intervention Sessions</measure>
    <time_frame>Assessments will be conducted once in Week 9</time_frame>
    <description>Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly Intervention Sessions</measure>
    <time_frame>Assessments will be conducted once in Week 10</time_frame>
    <description>Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly Intervention Sessions</measure>
    <time_frame>Assessments will be conducted once in Week 11</time_frame>
    <description>Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly Intervention Sessions</measure>
    <time_frame>Assessments will be conducted once in Week 12</time_frame>
    <description>Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 1</time_frame>
    <description>Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 2</time_frame>
    <description>Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 3</time_frame>
    <description>Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 4</time_frame>
    <description>Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 5</time_frame>
    <description>Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 6</time_frame>
    <description>Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 7</time_frame>
    <description>Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 8</time_frame>
    <description>Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 9</time_frame>
    <description>Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 10</time_frame>
    <description>Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 11</time_frame>
    <description>Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 12</time_frame>
    <description>Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with home practice sessions at 3 months</measure>
    <time_frame>Assessments will be conducted at 3 months post intervention</time_frame>
    <description>Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Session Attendance (reported as percentages)</measure>
    <time_frame>Assessments will be conducted once at Week 1</time_frame>
    <description>The investigators will collect attendance after each weekly session (&gt;75% of sessions attended is considered good attendance).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Session Attendance (reported as percentages)</measure>
    <time_frame>Assessments will be conducted once at Week 2</time_frame>
    <description>The investigators will collect attendance after each weekly session (&gt;75% of sessions attended is considered good attendance).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Session Attendance (reported as percentages)</measure>
    <time_frame>Assessments will be conducted once at Week 3</time_frame>
    <description>The investigators will collect attendance after each weekly session (&gt;75% of sessions attended is considered good attendance).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Session Attendance (reported as percentages)</measure>
    <time_frame>Assessments will be conducted once at Week 4</time_frame>
    <description>The investigators will collect attendance after each weekly session (&gt;75% of sessions attended is considered good attendance).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Session Attendance (reported as percentages)</measure>
    <time_frame>Assessments will be conducted once at Week 5</time_frame>
    <description>The investigators will collect attendance after each weekly session (&gt;75% of sessions attended is considered good attendance).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Session Attendance (reported as percentages)</measure>
    <time_frame>Assessments will be conducted once at Week 6</time_frame>
    <description>The investigators will collect attendance after each weekly session (&gt;75% of sessions attended is considered good attendance).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Session Attendance (reported as percentages)</measure>
    <time_frame>Assessments will be conducted once at Week 7</time_frame>
    <description>The investigators will collect attendance after each weekly session (&gt;75% of sessions attended is considered good attendance).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Session Attendance (reported as percentages)</measure>
    <time_frame>Assessments will be conducted once at Week 8</time_frame>
    <description>The investigators will collect attendance after each weekly session (&gt;75% of sessions attended is considered good attendance).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Session Attendance (reported as percentages)</measure>
    <time_frame>Assessments will be conducted once at Week 9</time_frame>
    <description>The investigators will collect attendance after each weekly session (&gt;75% of sessions attended is considered good attendance).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Session Attendance (reported as percentages)</measure>
    <time_frame>Assessments will be conducted once at Week 10</time_frame>
    <description>The investigators will collect attendance after each weekly session (&gt;75% of sessions attended is considered good attendance).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Session Attendance (reported as percentages)</measure>
    <time_frame>Assessments will be conducted once at Week 11</time_frame>
    <description>The investigators will collect attendance after each weekly session (&gt;75% of sessions attended is considered good attendance).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Session Attendance (reported as percentages)</measure>
    <time_frame>Assessments will be conducted once at Week 12</time_frame>
    <description>The investigators will collect attendance after each weekly session (&gt;75% of sessions attended is considered good attendance).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once at Week 1</time_frame>
    <description>The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once at Week 2</time_frame>
    <description>The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once at Week 3</time_frame>
    <description>The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once at Week 4</time_frame>
    <description>The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once at Week 5</time_frame>
    <description>The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once at Week 6</time_frame>
    <description>The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once at Week 7</time_frame>
    <description>The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once at Week 8</time_frame>
    <description>The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once at Week 9</time_frame>
    <description>The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once at Week 10</time_frame>
    <description>The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once at Week 11</time_frame>
    <description>The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of weekly home practice sessions</measure>
    <time_frame>Assessments will be conducted once at Week 12</time_frame>
    <description>The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of home practice sessions at 3 months</measure>
    <time_frame>Assessments will be conducted at 3 months post intervention</time_frame>
    <description>The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 1</time_frame>
    <description>The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 2</time_frame>
    <description>The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 3</time_frame>
    <description>The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 4</time_frame>
    <description>The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 5</time_frame>
    <description>The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 6</time_frame>
    <description>The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 7</time_frame>
    <description>The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 8</time_frame>
    <description>The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 9</time_frame>
    <description>The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 10</time_frame>
    <description>The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 11</time_frame>
    <description>The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of home practice sessions</measure>
    <time_frame>Assessments will be conducted once in Week 12</time_frame>
    <description>The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of home practice sessions at 3 months</measure>
    <time_frame>Assessments will be conducted at 3 months post intervention</time_frame>
    <description>The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Will older people living with HIV still be practicing the intervention 3 months post intervention?</measure>
    <time_frame>Assessments will be conducted at 3 months post intervention</time_frame>
    <description>The investigators will also collect information on home practice sessions: how often did they practice, for how long were each practice session, satisfaction with the video and practice sessions three months post intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Mental Health at 2 weeks post intervention</measure>
    <time_frame>Assessments will be conducted at baseline, 2 weeks post intervention</time_frame>
    <description>Mental Health will be assessed using the following standardized scale: the Depression Anxiety &amp; Stress Scale (Ng, et al.; DASS-21 items). The DASS responses range from 0-3. The total score ranges from 0-42, with higher scores reflecting more severe symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mental Health at 3 months post intervention</measure>
    <time_frame>Assessments will be conducted at baseline, 3 months post intervention</time_frame>
    <description>Mental Health will be assessed using the following standardized scale: the Depression Anxiety &amp; Stress Scale (Ng, et al.; DASS-21 items). The DASS responses range from 0-3. The total score ranges from 0-42, with higher scores reflecting more severe symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Health Status as measured by The Revised Sign &amp; Symptom Check-List for HIV (Holzemer, et al.; 45 items) at 2 weeks post intervention</measure>
    <time_frame>Assessments will be conducted at baseline, 2 weeks post intervention</time_frame>
    <description>Physical Health will be assessed using the following standardized scale: The Revised Sign &amp; Symptom Check-List for HIV (Holzemer, et al.; 45 items). The Symptoms Checklist total scores range from 0-135, with greater scores reflecting more symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Health Status as measured by The Revised Sign &amp; Symptom Check-List for HIV (Holzemer, et al.; 45 items) at 3 months post intervention</measure>
    <time_frame>Assessments will be conducted at baseline, 3 months post intervention</time_frame>
    <description>Physical Health will be assessed using the following standardized scale: The Revised Sign &amp; Symptom Check-List for HIV (Holzemer, et al.; 45 items). The Symptoms Checklist total scores range from 0-135, with greater scores reflecting more symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Health Status as measured by The HIV-related Fatigue Scale (Belza, et al.,16 items) at 2 weeks post intervention</measure>
    <time_frame>Assessments will be conducted at baseline, 2 weeks post intervention</time_frame>
    <description>Physical Health will be assessed using the following standardized scale: The HIV-related Fatigue Scale (Belza, et al.,16 items) . The total score for the Fatigue Scale ranges from 0-50, with greater scores reflecting more fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Health Status as measured by The HIV-related Fatigue Scale (Belza, et al.,16 items) at 3 months post intervention</measure>
    <time_frame>Assessments will be conducted at baseline, 3 months post intervention</time_frame>
    <description>Physical Health will be assessed using the following standardized scale: The HIV-related Fatigue Scale (Belza, et al.,16 items) . The total score for the Fatigue Scale ranges from 0-50, with greater scores reflecting more fatigue.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Mental Health</condition>
  <condition>Physical Health</condition>
  <arm_group>
    <arm_group_label>Qigong Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The qigong intervention consists of 1 hour/week qigong classes for 12 weeks to be delivered virtually. The first 2 weeks will include 2 hours/week classes. In addition, each participant will be instructed to practice qigong at home for 90 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Qigong</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>This group will also have 1 hour/weekly class delivered virtually that includes movements that are similar to qigong but will not include the meditation or breathwork that will be included in the actual qigong intervention arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment-as-usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will receive no classes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Qigong Intervention</intervention_name>
    <description>Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.</description>
    <arm_group_label>Qigong Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sham Qigong</intervention_name>
    <description>This intervention includes similar body movements to qigong; however, it does not have the meditative or breath work.</description>
    <arm_group_label>Sham Qigong</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50 year or older;&#xD;
&#xD;
          -  HIV+,&#xD;
&#xD;
          -  able to provide consent; and&#xD;
&#xD;
          -  willing to participate for the length of the intervention.&#xD;
&#xD;
        Exclusion criteria.&#xD;
&#xD;
          -  Participants who are unable to stand for 10-minute segments (i.e., wheelchair or&#xD;
             walker bound); and&#xD;
&#xD;
          -  participants who have substantial (regular weekly practice for more than 3 months in&#xD;
             the past 12 months) experience with mind-body interventions will be excluded because&#xD;
             the control group may be contaminated by prior experience.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Borinquen Medical Centers of Miami Dade</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33137</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 16, 2018</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>January 11, 2023</last_update_submitted>
  <last_update_submitted_qc>January 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>qigong</keyword>
  <keyword>HIV</keyword>
  <!-- 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/NCT03840525
org study id: 1R34AT009966-01
nct id: NCT03840525
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will develop and pilot test a qigong intervention with older people (50 and over)
      living with HIV. Participants (n=72) will be randomly assigned to one of 3 conditions: the
      qigong intervention, a sham qigong intervention, and a usual standard of care group. The
      study will determine the acceptability and feasibility of the study. If found effective, the
      qigong intervention will also improve the psychological and physical symptoms of older people
      living with HIV.
Half of those infected with HIV in the United States are over 50 years of age; this is
      expected to increase to 70% by 2020. Yet, few interventions exist for older people living
      with HIV/AIDS that address psychological symptoms, and none that address physical symptoms,
      both of which are prevalent in this population. There is a need to find innovative and
      accessible interventions that can help older people living with HIV/AIDS to manage their
      symptoms. Mind-body interventions, like Tai chi and Qi gong (TCQ), improves both physical and
      psychological health, and might also promote immune functioning. TCQ is a series of slow,
      low-impact meditative movements that integrates breath work, meditation, and stances. The
      investigators propose the refinement, adaptation, acceptability and feasibility testing of a
      standardized TCQ intervention shown efficacious with cancer patients, to an ethnically
      diverse population of older people living with HIV/AIDS, with the goal of enhancing their
      ability to manage psychological and physical symptoms. Thus, this study proposes three aims:
      (i) to refine and culturally adapt a TCQ intervention protocol for a diverse sample of older
      people living with HIV/AIDS (50 years of age or older); (ii) to evaluate the acceptability
      and feasibility of the TCQ intervention, a sham qigong control condition, and a standard of
      care control condition for older people living with HIV/AIDS (n = 60); and (iii) explore any
      preliminary evidence of efficacy of the TCQ intervention and the control conditions on
      alleviating physical and psychological symptoms. Participants will be recruited from a
      federally qualified health center in Miami, Florida. Adaptation of the TCQ intervention, the
      first aim, will be done through qualitative research. An expert panel discussion, key
      informant interviews, and three focus groups will be conducted, and analyzed by thematically
      based content analysis. To address aims 2 and 3, the investigators will conduct a pilot
      study; participants will be randomized to one of 3 conditions: the TCQ intervention, a sham
      qigong condition, and a standard of care condition. This is a pilot study to assess
      feasibility, acceptability, and preliminary efficacy, therefore, analyses will be primarily
      descriptive. The investigators will assess feasibility and acceptability through
      questionnaires and adherence to TCQ. The investigators will assess preliminary evidence of
      efficacy by looking at instruments that measure depression, anxiety, social support, as well
      as clinical outcomes. These will be described through proportions, means, and changes over
      time through graphing techniques. Outcomes will be assessed at baseline, post-intervention,
      and at three months follow up. The investigators will conduct preliminary models that will
      provide information on estimating effect size and power needed for a larger clinical trial.
      Note: Due to the coronavirus pandemic, this intervention was adapted from an in-person
      intervention to a virtual intervention. The intervention is exactly the same except for the
      difference in delivery method.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study will implement a 3 arm study including the qigong intervention, sham qigong intervention, and a treatment as usual condition. The qigong and sham qigong groups will be delivered virtually due to the coronavirus pandemic.
primary purpose: Other
masking: Single (Participant)
masking description: There will be a sham qigong arm of the study to mask qigong participation for the participants
measure: Satisfaction with weekly Intervention Sessions
time frame: Assessments will be conducted once in Week 1
description: Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction
measure: Satisfaction with weekly Intervention Sessions
time frame: Assessments will be conducted once in Week 2
description: Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction
measure: Satisfaction with weekly Intervention Sessions
time frame: Assessments will be conducted once in Week 3
description: Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction
measure: Satisfaction with weekly Intervention Sessions
time frame: Assessments will be conducted once in Week 4
description: Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction
measure: Satisfaction with weekly Intervention Sessions
time frame: Assessments will be conducted once in Week 5
description: Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction
measure: Satisfaction with weekly Intervention Sessions
time frame: Assessments will be conducted once in Week 6
description: Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction
measure: Satisfaction with weekly Intervention Sessions
time frame: Assessments will be conducted once in Week 7
description: Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction
measure: Satisfaction with weekly Intervention Sessions
time frame: Assessments will be conducted once in Week 8
description: Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction
measure: Satisfaction with weekly Intervention Sessions
time frame: Assessments will be conducted once in Week 9
description: Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction
measure: Satisfaction with weekly Intervention Sessions
time frame: Assessments will be conducted once in Week 10
description: Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction
measure: Satisfaction with weekly Intervention Sessions
time frame: Assessments will be conducted once in Week 11
description: Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction
measure: Satisfaction with weekly Intervention Sessions
time frame: Assessments will be conducted once in Week 12
description: Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction
measure: Satisfaction with weekly home practice sessions
time frame: Assessments will be conducted once in Week 1
description: Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction
measure: Satisfaction with weekly home practice sessions
time frame: Assessments will be conducted once in Week 2
description: Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction
measure: Satisfaction with weekly home practice sessions
time frame: Assessments will be conducted once in Week 3
description: Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction
measure: Satisfaction with weekly home practice sessions
time frame: Assessments will be conducted once in Week 4
description: Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction
measure: Satisfaction with weekly home practice sessions
time frame: Assessments will be conducted once in Week 5
description: Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction
measure: Satisfaction with weekly home practice sessions
time frame: Assessments will be conducted once in Week 6
description: Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction
measure: Satisfaction with weekly home practice sessions
time frame: Assessments will be conducted once in Week 7
description: Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction
measure: Satisfaction with weekly home practice sessions
time frame: Assessments will be conducted once in Week 8
description: Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction
measure: Satisfaction with weekly home practice sessions
time frame: Assessments will be conducted once in Week 9
description: Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction
measure: Satisfaction with weekly home practice sessions
time frame: Assessments will be conducted once in Week 10
description: Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction
measure: Satisfaction with weekly home practice sessions
time frame: Assessments will be conducted once in Week 11
description: Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction
measure: Satisfaction with weekly home practice sessions
time frame: Assessments will be conducted once in Week 12
description: Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction
measure: Satisfaction with home practice sessions at 3 months
time frame: Assessments will be conducted at 3 months post intervention
description: Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction
measure: Intervention Session Attendance (reported as percentages)
time frame: Assessments will be conducted once at Week 1
description: The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
measure: Intervention Session Attendance (reported as percentages)
time frame: Assessments will be conducted once at Week 2
description: The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
measure: Intervention Session Attendance (reported as percentages)
time frame: Assessments will be conducted once at Week 3
description: The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
measure: Intervention Session Attendance (reported as percentages)
time frame: Assessments will be conducted once at Week 4
description: The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
measure: Intervention Session Attendance (reported as percentages)
time frame: Assessments will be conducted once at Week 5
description: The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
measure: Intervention Session Attendance (reported as percentages)
time frame: Assessments will be conducted once at Week 6
description: The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
measure: Intervention Session Attendance (reported as percentages)
time frame: Assessments will be conducted once at Week 7
description: The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
measure: Intervention Session Attendance (reported as percentages)
time frame: Assessments will be conducted once at Week 8
description: The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
measure: Intervention Session Attendance (reported as percentages)
time frame: Assessments will be conducted once at Week 9
description: The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
measure: Intervention Session Attendance (reported as percentages)
time frame: Assessments will be conducted once at Week 10
description: The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
measure: Intervention Session Attendance (reported as percentages)
time frame: Assessments will be conducted once at Week 11
description: The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
measure: Intervention Session Attendance (reported as percentages)
time frame: Assessments will be conducted once at Week 12
description: The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
measure: Duration of weekly home practice sessions
time frame: Assessments will be conducted once at Week 1
description: The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
measure: Duration of weekly home practice sessions
time frame: Assessments will be conducted once at Week 2
description: The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
measure: Duration of weekly home practice sessions
time frame: Assessments will be conducted once at Week 3
description: The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
measure: Duration of weekly home practice sessions
time frame: Assessments will be conducted once at Week 4
description: The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
measure: Duration of weekly home practice sessions
time frame: Assessments will be conducted once at Week 5
description: The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
measure: Duration of weekly home practice sessions
time frame: Assessments will be conducted once at Week 6
description: The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
measure: Duration of weekly home practice sessions
time frame: Assessments will be conducted once at Week 7
description: The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
measure: Duration of weekly home practice sessions
time frame: Assessments will be conducted once at Week 8
description: The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
measure: Duration of weekly home practice sessions
time frame: Assessments will be conducted once at Week 9
description: The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
measure: Duration of weekly home practice sessions
time frame: Assessments will be conducted once at Week 10
description: The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
measure: Duration of weekly home practice sessions
time frame: Assessments will be conducted once at Week 11
description: The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
measure: Duration of weekly home practice sessions
time frame: Assessments will be conducted once at Week 12
description: The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
measure: Duration of home practice sessions at 3 months
time frame: Assessments will be conducted at 3 months post intervention
description: The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
measure: Frequency of home practice sessions
time frame: Assessments will be conducted once in Week 1
description: The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
measure: Frequency of home practice sessions
time frame: Assessments will be conducted once in Week 2
description: The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
measure: Frequency of home practice sessions
time frame: Assessments will be conducted once in Week 3
description: The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
measure: Frequency of home practice sessions
time frame: Assessments will be conducted once in Week 4
description: The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
measure: Frequency of home practice sessions
time frame: Assessments will be conducted once in Week 5
description: The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
measure: Frequency of home practice sessions
time frame: Assessments will be conducted once in Week 6
description: The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
measure: Frequency of home practice sessions
time frame: Assessments will be conducted once in Week 7
description: The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
measure: Frequency of home practice sessions
time frame: Assessments will be conducted once in Week 8
description: The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
measure: Frequency of home practice sessions
time frame: Assessments will be conducted once in Week 9
description: The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
measure: Frequency of home practice sessions
time frame: Assessments will be conducted once in Week 10
description: The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
measure: Frequency of home practice sessions
time frame: Assessments will be conducted once in Week 11
description: The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
measure: Frequency of home practice sessions
time frame: Assessments will be conducted once in Week 12
description: The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
measure: Frequency of home practice sessions at 3 months
time frame: Assessments will be conducted at 3 months post intervention
description: The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
measure: Will older people living with HIV still be practicing the intervention 3 months post intervention?
time frame: Assessments will be conducted at 3 months post intervention
description: The investigators will also collect information on home practice sessions: how often did they practice, for how long were each practice session, satisfaction with the video and practice sessions three months post intervention.
measure: Change in Mental Health at 2 weeks post intervention
time frame: Assessments will be conducted at baseline, 2 weeks post intervention
description: Mental Health will be assessed using the following standardized scale: the Depression Anxiety & Stress Scale (Ng, et al.; DASS-21 items). The DASS responses range from 0-3. The total score ranges from 0-42, with higher scores reflecting more severe symptoms
measure: Change in Mental Health at 3 months post intervention
time frame: Assessments will be conducted at baseline, 3 months post intervention
description: Mental Health will be assessed using the following standardized scale: the Depression Anxiety & Stress Scale (Ng, et al.; DASS-21 items). The DASS responses range from 0-3. The total score ranges from 0-42, with higher scores reflecting more severe symptoms
measure: Change in Physical Health Status as measured by The Revised Sign & Symptom Check-List for HIV (Holzemer, et al.; 45 items) at 2 weeks post intervention
time frame: Assessments will be conducted at baseline, 2 weeks post intervention
description: Physical Health will be assessed using the following standardized scale: The Revised Sign & Symptom Check-List for HIV (Holzemer, et al.; 45 items). The Symptoms Checklist total scores range from 0-135, with greater scores reflecting more symptoms.
measure: Change in Physical Health Status as measured by The Revised Sign & Symptom Check-List for HIV (Holzemer, et al.; 45 items) at 3 months post intervention
time frame: Assessments will be conducted at baseline, 3 months post intervention
description: Physical Health will be assessed using the following standardized scale: The Revised Sign & Symptom Check-List for HIV (Holzemer, et al.; 45 items). The Symptoms Checklist total scores range from 0-135, with greater scores reflecting more symptoms.
measure: Change in Physical Health Status as measured by The HIV-related Fatigue Scale (Belza, et al.,16 items) at 2 weeks post intervention
time frame: Assessments will be conducted at baseline, 2 weeks post intervention
description: Physical Health will be assessed using the following standardized scale: The HIV-related Fatigue Scale (Belza, et al.,16 items) . The total score for the Fatigue Scale ranges from 0-50, with greater scores reflecting more fatigue.
measure: Change in Physical Health Status as measured by The HIV-related Fatigue Scale (Belza, et al.,16 items) at 3 months post intervention
time frame: Assessments will be conducted at baseline, 3 months post intervention
description: Physical Health will be assessed using the following standardized scale: The HIV-related Fatigue Scale (Belza, et al.,16 items) . The total score for the Fatigue Scale ranges from 0-50, with greater scores reflecting more fatigue.
arm group label: Qigong Intervention
arm group type: Experimental
description: The qigong intervention consists of 1 hour/week qigong classes for 12 weeks to be delivered virtually. The first 2 weeks will include 2 hours/week classes. In addition, each participant will be instructed to practice qigong at home for 90 minutes.
arm group label: Sham Qigong
arm group type: Sham Comparator
description: This group will also have 1 hour/weekly class delivered virtually that includes movements that are similar to qigong but will not include the meditation or breathwork that will be included in the actual qigong intervention arm.
arm group label: Treatment-as-usual
arm group type: No Intervention
description: This group will receive no classes.
intervention type: Behavioral
intervention name: The Qigong Intervention
description: Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.
arm group label: Qigong Intervention
intervention type: Behavioral
intervention name: Sham Qigong
description: This intervention includes similar body movements to qigong; however, it does not have the meditative or breath work.
arm group label: Sham Qigong
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor