<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/NCT04430751</url>
  </required_header>
  <id_info>
    <org_study_id>250-37</org_study_id>
    <nct_id>NCT04430751</nct_id>
  </id_info>
  <brief_title>Medical Qigong for Mobility and Balance Self-Confidence</brief_title>
  <official_title>Medical Qigong for Mobility and Balance Self-Confidence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The population is aging and increasingly at risk for falls and fractures with substantial&#xD;
      consequences to wellbeing, health and costs. Training interventions such as Tai Chi have been&#xD;
      demonstrated to help reduce these risks. Tai chi is a subset of both martial and medical qi&#xD;
      gong.&#xD;
&#xD;
      This is a prospective intervention study with wait time control that will examine the ability&#xD;
      of a manualized medical qi gong training protocol improve balance, gait and health&#xD;
      self-confidence.&#xD;
&#xD;
      The intervention is a 12 week manualized medical qi gong training program where students are&#xD;
      taught a progressive series of 10 qi gong forms that are designed to build upon each other&#xD;
      and restore balance and function. These forms involve both physical movement and&#xD;
      visualization.&#xD;
&#xD;
      The Community Balance and Mobility scale (a performance based measure) and&#xD;
      Activities-specified Balance Confidence scale (a survey)will be the prime outcome instruments&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 16, 2018</start_date>
  <completion_date type="Actual">August 15, 2018</completion_date>
  <primary_completion_date type="Actual">August 15, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Community Balance and Mobility Scale</measure>
    <time_frame>through study completion, up to 16 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Activities-specific Balance Confidence Scale</measure>
    <time_frame>through study completion, up to 16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Falls, Balance Self-confidence</condition>
  <arm_group>
    <arm_group_label>Immediate start</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>wait time control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Medical QiGong training</intervention_name>
    <description>The study intervention consisted of a 12-week training program that introduced students to a progressive series of 10 QiGong &quot;forms&quot; that are designed to build upon each other to restore balance and function and to enhance well-being. These forms involve both physical movement and visualization.</description>
    <arm_group_label>Immediate start</arm_group_label>
    <arm_group_label>wait time control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 50 years of age or older who presented at the two study locations&#xD;
             (Massachusetts, Arizona) were considered eligible for participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to participate in informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>James E. Stahl</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>blinded de-identified information will be shared at request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </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/NCT04430751
org study id: 250-37
nct id: NCT04430751
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The population is aging and increasingly at risk for falls and fractures with substantial
      consequences to wellbeing, health and costs. Training interventions such as Tai Chi have been
      demonstrated to help reduce these risks. Tai chi is a subset of both martial and medical qi
      gong.

      This is a prospective intervention study with wait time control that will examine the ability
      of a manualized medical qi gong training protocol improve balance, gait and health
      self-confidence.

      The intervention is a 12 week manualized medical qi gong training program where students are
      taught a progressive series of 10 qi gong forms that are designed to build upon each other
      and restore balance and function. These forms involve both physical movement and
      visualization.

      The Community Balance and Mobility scale (a performance based measure) and
      Activities-specified Balance Confidence scale (a survey)will be the prime outcome instruments
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Community Balance and Mobility Scale
time frame: through study completion, up to 16 weeks
measure: Activities-specific Balance Confidence Scale
time frame: through study completion, up to 16 weeks
arm group label: Immediate start
arm group type: Active Comparator
arm group label: wait time control
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Medical QiGong training
description: The study intervention consisted of a 12-week training program that introduced students to a progressive series of 10 QiGong "forms" that are designed to build upon each other to restore balance and function and to enhance well-being. These forms involve both physical movement and visualization.
arm group label: Immediate start
arm group label: wait time control
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: James E. Stahl
investigator title: MD
sharing ipd: Yes
ipd description: blinded de-identified information will be shared at request
ipd info type: Study Protocol