<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/NCT03831737</url>
  </required_header>
  <id_info>
    <org_study_id>11328</org_study_id>
    <nct_id>NCT03831737</nct_id>
  </id_info>
  <brief_title>Team-based Ergonomics Educational Model for Workplace WELLNESS Improvement: A Pilot Study</brief_title>
  <acronym>TEEM WELLNESS</acronym>
  <official_title>Team-based Ergonomics Educational Model for Workplace WELLNESS Improvement: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Milton S. Hershey 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>
      This research is being done to explore the potential benefit of a physical therapist-guided&#xD;
      stretching program on musculoskeletal pain and well-being.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Actual">September 10, 2019</completion_date>
  <primary_completion_date type="Actual">September 10, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SF-36</measure>
    <time_frame>change from 3 month time point to 6 month time point</time_frame>
    <description>The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CMDQ</measure>
    <time_frame>change from 3 month time point to 6 month time point</time_frame>
    <description>The Cornell Musculoskeletal Discomfort Questionnaires (CMDQ) is a questionnaire based on previous published research studies of musculoskeletal discomfort among office workers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Sit and Reach</measure>
    <time_frame>baseline, 3 months, 6 months, change from 3 month time point to 6 month time point</time_frame>
    <description>The sit and reach test is a common measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36</measure>
    <time_frame>baseline, 3 months</time_frame>
    <description>The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CMDQ</measure>
    <time_frame>baseline, 3 months</time_frame>
    <description>The Cornell Musculoskeletal Discomfort Questionnaires (CMDQ) is a questionnaire based on previous published research studies of musculoskeletal discomfort among office workers.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>MSDs</condition>
  <condition>Muscle Pain</condition>
  <arm_group>
    <arm_group_label>Group 1: In-Person</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the initial 3 month control period, subjects are asked not to begin any new exercise or stretching program during this time.&#xD;
During the 3 month intervention period that follows, subjects will participate in in-person physical therapist-led instructional sessions three times per week. Each stretch will be performed twice, one on the left and one on the right. The therapist will describe what to do and briefly demonstrate each stretch. Stretches will be held for 45-60 seconds with therapist instructions and modification as needed based on subject technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: Video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the initial 3 month control period, subjects are asked not to begin any new exercise or stretching program during this time.&#xD;
During the 3 month intervention period that follows, subjects will complete sessions three times per week, led by a physical therapist and viewed remotely via pre-recorded video using a smartphone application.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>stretching exercises</intervention_name>
    <description>Head/neck stretches&#xD;
Head tilt side to side&#xD;
Cross-chest stretch Torso stretches&#xD;
Side stretch&#xD;
Mid-back stretch Lower limb&#xD;
Standing quadriceps stretch&#xD;
Standing hamstring stretch</description>
    <arm_group_label>Group 1: In-Person</arm_group_label>
    <arm_group_label>Group 2: Video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HMC/COM staff (faculty, residents, fellows, APPs, physical/occupational therapists,&#xD;
             nurses, schedulers, etc.)&#xD;
&#xD;
          -  At least 18 years old&#xD;
&#xD;
          -  Willing and able to participate in all study procedures&#xD;
&#xD;
          -  Willing and able to provide informed consent&#xD;
&#xD;
          -  Group 2 subjects must have access to a computer with internet or an iPhone or Android&#xD;
             smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who do not meet all inclusion criteria will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aiesha Ahmed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State Health Milton S. Hershey Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Majid Dadgar-Kiani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Milton S. Hershey Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn State Health Milton S. Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>December 20, 2019</last_update_submitted>
  <last_update_submitted_qc>December 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Aiesha Ahmed</investigator_full_name>
    <investigator_title>Assistant Professor, Neuromuscular Neurology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myalgia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03831737
org study id: 11328
nct id: NCT03831737
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This research is being done to explore the potential benefit of a physical therapist-guided
      stretching program on musculoskeletal pain and well-being.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: SF-36
time frame: change from 3 month time point to 6 month time point
description: The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures.
measure: CMDQ
time frame: change from 3 month time point to 6 month time point
description: The Cornell Musculoskeletal Discomfort Questionnaires (CMDQ) is a questionnaire based on previous published research studies of musculoskeletal discomfort among office workers.
measure: Modified Sit and Reach
time frame: baseline, 3 months, 6 months, change from 3 month time point to 6 month time point
description: The sit and reach test is a common measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles.
measure: SF-36
time frame: baseline, 3 months
description: The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures.
measure: CMDQ
time frame: baseline, 3 months
description: The Cornell Musculoskeletal Discomfort Questionnaires (CMDQ) is a questionnaire based on previous published research studies of musculoskeletal discomfort among office workers.
arm group label: Group 1: In-Person
arm group type: Experimental
description: During the initial 3 month control period, subjects are asked not to begin any new exercise or stretching program during this time.
During the 3 month intervention period that follows, subjects will participate in in-person physical therapist-led instructional sessions three times per week. Each stretch will be performed twice, one on the left and one on the right. The therapist will describe what to do and briefly demonstrate each stretch. Stretches will be held for 45-60 seconds with therapist instructions and modification as needed based on subject technique.
arm group label: Group 2: Video
arm group type: Experimental
description: During the initial 3 month control period, subjects are asked not to begin any new exercise or stretching program during this time.
During the 3 month intervention period that follows, subjects will complete sessions three times per week, led by a physical therapist and viewed remotely via pre-recorded video using a smartphone application.
intervention type: Behavioral
intervention name: stretching exercises
description: Head/neck stretches
Head tilt side to side
Cross-chest stretch Torso stretches
Side stretch
Mid-back stretch Lower limb
Standing quadriceps stretch
Standing hamstring stretch
arm group label: Group 1: In-Person
arm group label: Group 2: Video
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aiesha Ahmed, MD
role: Principal Investigator
affiliation: Penn State Health Milton S. Hershey Medical Center
last name: Majid Dadgar-Kiani, MD
role: Principal Investigator
affiliation: Milton S. Hershey Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Aiesha Ahmed
investigator title: Assistant Professor, Neuromuscular Neurology
mesh term: Myalgia
sharing ipd: No