<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/NCT03802578</url>
  </required_header>
  <id_info>
    <org_study_id>680/10-06-2016</org_study_id>
    <nct_id>NCT03802578</nct_id>
  </id_info>
  <brief_title>The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients</brief_title>
  <official_title>The Impact of Exercise on Hand Function, on Activities of Daily Living (ADLs) Performance and Quality of Life of Patients With Systemic Lupus Erythematosus (SLE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National and Kapodistrian University of Athens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National and Kapodistrian University of Athens</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A total of 240 consecutive SLE patients fulfilling the SLICC classification criteria was&#xD;
      evaluated. Sixty two patients who met the inclusion criteria were randomly assigned to the&#xD;
      exercise group (n=32) or the control group (n=30).&#xD;
&#xD;
      Patients in the exercise group performed a program of strengthening, stretching and&#xD;
      resistance upper limbs exercises, of 30 minutes duration daily, for 12 weeks. Performance of&#xD;
      daily activities was evaluated with the DASH and HAQ questionnaires, grip and pinch strength&#xD;
      with the Jamar dynamometer and pinch gauge tools respectively, dexterity with the Purdue&#xD;
      pegboard test and the quality of life with the LUPUSQoL questionnaire at 0, 6, 12 (end of the&#xD;
      exercise program) and 24 weeks for both groups. SLE activity and cumulative organ damage were&#xD;
      evaluated with the SLE disease activity index 2000 (SLEDAI-2K) and SLICC/ACR-DI,&#xD;
      respectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 240 consecutive SLE patients fulfilling the SLICC classification criteria was&#xD;
      evaluated. Sixty two patients who met the inclusion criteria [age&gt;18, upper limb arthralgias,&#xD;
      and DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire score&gt;10)] were randomly&#xD;
      assigned to the exercise group (n=32) or the control group (n=30).&#xD;
&#xD;
      Patients in the exercise group performed a program of strengthening, stretching and&#xD;
      resistance upper limbs exercises, of 30 minutes duration daily, for 12 weeks. Performance of&#xD;
      daily activities was evaluated with the DASH and HAQ questionnaires, grip and pinch strength&#xD;
      with the Jamar dynamometer and pinch gauge tools respectively, dexterity with the Purdue&#xD;
      pegboard test and the quality of life with the LUPUSQoL questionnaire at 0, 6, 12 (end of the&#xD;
      exercise program) and 24 weeks for both groups. SLE activity and cumulative organ damage were&#xD;
      evaluated with the SLE disease activity index 2000 (SLEDAI-2K) and SLICC/ACR-DI,&#xD;
      respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2016</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of DASH questionnaire</measure>
    <time_frame>Baseline, 6, 12, 24 weeks</time_frame>
    <description>Hand function was measured with DASH Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change of HAQ questionnaire</measure>
    <time_frame>Baseline, 6, 12, 24 weeks</time_frame>
    <description>Hand function was measured with HAQ Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of Grip strength</measure>
    <time_frame>Baseline, 6, 12, 24 weeks</time_frame>
    <description>Grip strength was measured with Jamar Dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of Pinch strength</measure>
    <time_frame>Baseline, 6, 12, 24 weeks</time_frame>
    <description>Pinch strength was measured with Jamar pinch gauge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of Dexterity</measure>
    <time_frame>Baseline, 6, 12, 24 weeks</time_frame>
    <description>Dexterity was measured with Purdue Pegboard test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of Quality of Life</measure>
    <time_frame>Baseline, 6, 12, 24 weeks</time_frame>
    <description>Quality of Life was measured with LupusQoL Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <condition>Arthralgia</condition>
  <arm_group>
    <arm_group_label>EXERCISE GROUP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises (Hand exercise), of 30 minutes duration daily, for 12 weeks in addition to medical care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL GROUP</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the control group continued their usual medical care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HAND EXERCISE</intervention_name>
    <arm_group_label>EXERCISE GROUP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  SLE patients fulfilling the SLICC classification criteria&#xD;
&#xD;
          -  Upper limb arthralgias&#xD;
&#xD;
          -  DASH score&gt;10&#xD;
&#xD;
          -  Stable drug regimen≥3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hand fracture or surgery in last 6 months&#xD;
&#xD;
          -  Physiotherapy program in last month&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MARIA TEKTONIDOU, Ass. Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>National and Kapodistrian University of Athens</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>General Hospital of Athens 'Laiko'</name>
      <address>
        <city>Athens</city>
        <state>Attica</state>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Elefsina 'Thriasio'</name>
      <address>
        <city>Elefsina</city>
        <state>Attica</state>
        <zip>19600</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National and Kapodistrian University of Athens</investigator_affiliation>
    <investigator_full_name>Maria Tektonidou</investigator_full_name>
    <investigator_title>Ass. Professor Medical School</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Hand function</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthralgia</mesh_term>
    <mesh_term>Lupus Erythematosus, Systemic</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/NCT03802578
org study id: 680/10-06-2016
nct id: NCT03802578
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A total of 240 consecutive SLE patients fulfilling the SLICC classification criteria was
      evaluated. Sixty two patients who met the inclusion criteria were randomly assigned to the
      exercise group (n=32) or the control group (n=30).

      Patients in the exercise group performed a program of strengthening, stretching and
      resistance upper limbs exercises, of 30 minutes duration daily, for 12 weeks. Performance of
      daily activities was evaluated with the DASH and HAQ questionnaires, grip and pinch strength
      with the Jamar dynamometer and pinch gauge tools respectively, dexterity with the Purdue
      pegboard test and the quality of life with the LUPUSQoL questionnaire at 0, 6, 12 (end of the
      exercise program) and 24 weeks for both groups. SLE activity and cumulative organ damage were
      evaluated with the SLE disease activity index 2000 (SLEDAI-2K) and SLICC/ACR-DI,
      respectively.
A total of 240 consecutive SLE patients fulfilling the SLICC classification criteria was
      evaluated. Sixty two patients who met the inclusion criteria [age>18, upper limb arthralgias,
      and DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire score>10)] were randomly
      assigned to the exercise group (n=32) or the control group (n=30).

      Patients in the exercise group performed a program of strengthening, stretching and
      resistance upper limbs exercises, of 30 minutes duration daily, for 12 weeks. Performance of
      daily activities was evaluated with the DASH and HAQ questionnaires, grip and pinch strength
      with the Jamar dynamometer and pinch gauge tools respectively, dexterity with the Purdue
      pegboard test and the quality of life with the LUPUSQoL questionnaire at 0, 6, 12 (end of the
      exercise program) and 24 weeks for both groups. SLE activity and cumulative organ damage were
      evaluated with the SLE disease activity index 2000 (SLEDAI-2K) and SLICC/ACR-DI,
      respectively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: change of DASH questionnaire
time frame: Baseline, 6, 12, 24 weeks
description: Hand function was measured with DASH Questionnaire
measure: change of HAQ questionnaire
time frame: Baseline, 6, 12, 24 weeks
description: Hand function was measured with HAQ Questionnaire
measure: change of Grip strength
time frame: Baseline, 6, 12, 24 weeks
description: Grip strength was measured with Jamar Dynamometer
measure: change of Pinch strength
time frame: Baseline, 6, 12, 24 weeks
description: Pinch strength was measured with Jamar pinch gauge
measure: change of Dexterity
time frame: Baseline, 6, 12, 24 weeks
description: Dexterity was measured with Purdue Pegboard test
measure: change of Quality of Life
time frame: Baseline, 6, 12, 24 weeks
description: Quality of Life was measured with LupusQoL Questionnaire
arm group label: EXERCISE GROUP
arm group type: Experimental
description: Patients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises (Hand exercise), of 30 minutes duration daily, for 12 weeks in addition to medical care.
arm group label: CONTROL GROUP
arm group type: No Intervention
description: Patients in the control group continued their usual medical care.
intervention type: Behavioral
intervention name: HAND EXERCISE
arm group label: EXERCISE GROUP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MARIA TEKTONIDOU, Ass. Prof
role: Principal Investigator
affiliation: National and Kapodistrian University of Athens
facility: 
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: National and Kapodistrian University of Athens
investigator full name: Maria Tektonidou
investigator title: Ass. Professor Medical School
mesh term: Arthralgia
mesh term: Lupus Erythematosus, Systemic
sharing ipd: No