xml: <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/NCT05964894</url>
    </required_header>
    <id_info>
      <org_study_id>A-ER-108-235</org_study_id>
      <nct_id>NCT05964894</nct_id>
    </id_info>
    <brief_title>An Ergonomic Training With Exercise Program for Work-related Musculoskeletal Disorders Among Hemodialysis Nurse</brief_title>
    <acronym>WMSD</acronym>
    <official_title>Occupational Therapy for Work-related Musculoskeletal Disorders Among Hemodialysis Nurse</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jer-Hao Chang</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Cheng-Kung University Hospital</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 study aimed to examine the effectiveness of the 12-week ergonomic intervention developed&#xD;
        by Person-Environment-Occupation (PEO) model in improving musculoskeletal discomfort and&#xD;
        muscle strength for hemodialysis nurses. The maintenance effects of the intervention were&#xD;
        also evaluated after another 12-week follow-up.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Methods A cluster experimental design was used to conduct this study. Participants were&#xD;
        recruited from hemodialysis units at two medical centers in Taiwan and had complaints of&#xD;
        work-related musculoskeletal disorders (WMSDs) within the past six months. By PEO model, the&#xD;
        12-week intervention including ergonomic education and exercise program was designed based on&#xD;
        the job contents of hemodialysis nurses. In the study period, we used a mobile massager app&#xD;
        to reminder them and monitor their implementation of exercises. The outcome indicators were&#xD;
        measured before and after intervention as well as the follow-up after another 12 weeks. A&#xD;
        generalized estimating equations model was adopted to analyze the repeated measurements.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 1, 2019</start_date>
    <completion_date type="Actual">June 30, 2020</completion_date>
    <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>severity degree of muscular discomfort</measure>
      <time_frame>week 0</time_frame>
      <description>self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>muscle strength</measure>
      <time_frame>week 0</time_frame>
      <description>grip and pinch power; the muscle strength of neck extension, shoulder flexion/extension, and wrist flexion/extension of the dominant (maximal force of the muscles movement against in kilograms, the higher the stronger)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>severity degree of muscular discomfort</measure>
      <time_frame>week 12</time_frame>
      <description>self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>muscle strength</measure>
      <time_frame>week 12</time_frame>
      <description>grip and pinch power; the muscle strength of neck extension, shoulder flexion/extension, and wrist flexion/extension of the dominant (maximal force of the muscles movement against in kilograms, the higher the stronger)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>severity degree of muscular discomfort</measure>
      <time_frame>week 24</time_frame>
      <description>self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>muscle strength</measure>
      <time_frame>week 24</time_frame>
      <description>grip and pinch power; the muscle strength of neck extension, shoulder flexion/extension, and wrist flexion/extension of the dominant (maximal force of the muscles movement against in kilogram, the higher the stronger)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Subjective quality of life</measure>
      <time_frame>week 0</time_frame>
      <description>World Health Organization Quality of Life, Brief edition, Taiwan version (1-5, higher score for higher quality of life)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective quality of life</measure>
      <time_frame>week 24</time_frame>
      <description>World Health Organization Quality of Life, Brief edition, Taiwan version (1-5, higher score for higher quality of life)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">38</enrollment>
    <condition>Musculoskeletal Disorders</condition>
    <arm_group>
      <arm_group_label>Ergonomic training group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The ergonomic training group received a 12-week ergonomic training program.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No training group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The no training group did not receive any training program.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>ergonomic training</intervention_name>
      <description>ergonomic education &amp; exercise training</description>
      <arm_group_label>Ergonomic training group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  20 to 65 years old, which is the legal age range of adult for work in Taiwan&#xD;
  &#xD;
            -  registered nurses to work full time in the hemodialysis unit more than 6 months,&#xD;
  &#xD;
            -  having complaint of WMSDs within previous 6 months before this study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  having no musculoskeletal disorder related to the job&#xD;
  &#xD;
            -  to care less than 4 patients in 4 hours, which was below the Taiwan workload reference&#xD;
               for nurse in hemodialysis job&#xD;
  &#xD;
            -  to have any other consideration to keep from 12- week physical exercise program (such&#xD;
               as pregnancy, injury, disease, leave…, etc.).&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>JER-HAO CHANG, PH.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Cheng Kung University, College of Medicine</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Cheng Kung University</name>
        <address>
          <city>Tainan</city>
          <zip>701</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>National Cheng-Kung University Hospital</investigator_affiliation>
      <investigator_full_name>Jer-Hao Chang</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Musculoskeletal Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05964894
  org study id: A-ER-108-235
  nct id: NCT05964894
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to examine the effectiveness of the 12-week ergonomic intervention developed
        by Person-Environment-Occupation (PEO) model in improving musculoskeletal discomfort and
        muscle strength for hemodialysis nurses. The maintenance effects of the intervention were
        also evaluated after another 12-week follow-up.
  Methods A cluster experimental design was used to conduct this study. Participants were
        recruited from hemodialysis units at two medical centers in Taiwan and had complaints of
        work-related musculoskeletal disorders (WMSDs) within the past six months. By PEO model, the
        12-week intervention including ergonomic education and exercise program was designed based on
        the job contents of hemodialysis nurses. In the study period, we used a mobile massager app
        to reminder them and monitor their implementation of exercises. The outcome indicators were
        measured before and after intervention as well as the follow-up after another 12 weeks. A
        generalized estimating equations model was adopted to analyze the repeated measurements.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: severity degree of muscular discomfort
  time frame: week 0
  description: self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)
  measure: muscle strength
  time frame: week 0
  description: grip and pinch power; the muscle strength of neck extension, shoulder flexion/extension, and wrist flexion/extension of the dominant (maximal force of the muscles movement against in kilograms, the higher the stronger)
  measure: severity degree of muscular discomfort
  time frame: week 12
  description: self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)
  measure: muscle strength
  time frame: week 12
  description: grip and pinch power; the muscle strength of neck extension, shoulder flexion/extension, and wrist flexion/extension of the dominant (maximal force of the muscles movement against in kilograms, the higher the stronger)
  measure: severity degree of muscular discomfort
  time frame: week 24
  description: self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)
  measure: muscle strength
  time frame: week 24
  description: grip and pinch power; the muscle strength of neck extension, shoulder flexion/extension, and wrist flexion/extension of the dominant (maximal force of the muscles movement against in kilogram, the higher the stronger)
  measure: Subjective quality of life
  time frame: week 0
  description: World Health Organization Quality of Life, Brief edition, Taiwan version (1-5, higher score for higher quality of life)
  measure: Subjective quality of life
  time frame: week 24
  description: World Health Organization Quality of Life, Brief edition, Taiwan version (1-5, higher score for higher quality of life)
  arm group label: Ergonomic training group
  arm group type: Experimental
  description: The ergonomic training group received a 12-week ergonomic training program.
  arm group label: No training group
  arm group type: No Intervention
  description: The no training group did not receive any training program.
  intervention type: Other
  intervention name: ergonomic training
  description: ergonomic education & exercise training
  arm group label: Ergonomic training group
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: JER-HAO CHANG, PH.D.
  role: Principal Investigator
  affiliation: National Cheng Kung University, College of Medicine
  facility: 
  country: Taiwan
  responsible party type: Sponsor-Investigator
  investigator affiliation: National Cheng-Kung University Hospital
  investigator full name: Jer-Hao Chang
  investigator title: Associate Professor
  mesh term: Musculoskeletal Diseases
  sharing ipd: No