<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/NCT02219022</url>
  </required_header>
  <id_info>
    <org_study_id>CEP/UNIFESP 1826/10</org_study_id>
    <nct_id>NCT02219022</nct_id>
  </id_info>
  <brief_title>Progressive Resistance Exercise in Rheumatoid Arthritis</brief_title>
  <official_title>Progressive Resistance Exercise in Rheumatoid Arthritis Patients: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized controlled trial with rheumatoid arthritis patients will be realized. Patients&#xD;
      will be randomized into two groups. Experimental group will do a 12 weeks training of&#xD;
      progressive resistance exercise for global muscles and remain with the clinical treatment and&#xD;
      the control only remain with the clinical treatment. Patients will be evaluated at baseline,&#xD;
      after 6, 12 and 24 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 4</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain - Visual analogue scale</measure>
    <time_frame>baseline, 6, 12 and 24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in function capacity - Health Assessment questionaire</measure>
    <time_frame>Baseline, after 6, 12 and 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life - Short form 36</measure>
    <time_frame>baseline, after 6, 12 and 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in strength - 1 maximum repetition</measure>
    <time_frame>baseline, after 6, 12 and 24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient remain with their usual clinical treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in experimental group participated in a 12-week progressive resistance training using a maximum repetition exercise in which patients performed 1 Maximum Repetition with the maximum bearable weight. Once the 1 Maximum Repetitionwas determined, training was divided into the following regimen: 2 series of 8 repetitions, the first with 50% and the second with 70% of 1 Maximum Repetition.&#xD;
The exercises were knee extension and flexion and hip abduction and adduction, elbow extension and flexion, wrist extension and flexion and shoulder abduction and adduction and spine extension and flexion all performed in machines. The 1 Maximum Repetition load was reevaluated every 6 weeks.&#xD;
Patient remain with their usual clinical treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Experimental group</arm_group_label>
    <other_name>Clinical tretament</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental group</intervention_name>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Rheumatoid arthritis according to American College of Rheumatology 2010&#xD;
&#xD;
          -  Both genders&#xD;
&#xD;
          -  Age between 18 and 65 years&#xD;
&#xD;
          -  Functional class I, II and III&#xD;
&#xD;
          -  Stable medication within the three months preceding the study&#xD;
&#xD;
          -  Haven't done any kind of regular exercise (two or more times per Week) for at least&#xD;
             three months before study start&#xD;
&#xD;
          -  Have agreed to participate in the study and signed an informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participating in another type of study&#xD;
&#xD;
          -  Have difficulty understanding the evaluation tools with fibromyalgia&#xD;
&#xD;
          -  Joint deformities that make impossible do the exercises&#xD;
&#xD;
          -  Other musculoskeletal diseases&#xD;
&#xD;
          -  Other diseases that contraindicate exercises.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidade Federal de Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>04023-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 12, 2016</last_update_submitted>
  <last_update_submitted_qc>August 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Felipe Martinelli Lourenzi</investigator_full_name>
    <investigator_title>PT</investigator_title>
  </responsible_party>
  <keyword>Rheumatoid arthritis</keyword>
  <keyword>Progressive resistance exercise</keyword>
  <keyword>Pain</keyword>
  <keyword>Functional capacity</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Muscle strength</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <!-- 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/NCT02219022
org study id: CEP/UNIFESP 1826/10
nct id: NCT02219022
lead sponsor: 
collaborator: 
has dmc: No
A randomized controlled trial with rheumatoid arthritis patients will be realized. Patients
      will be randomized into two groups. Experimental group will do a 12 weeks training of
      progressive resistance exercise for global muscles and remain with the clinical treatment and
      the control only remain with the clinical treatment. Patients will be evaluated at baseline,
      after 6, 12 and 24 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in pain - Visual analogue scale
time frame: baseline, 6, 12 and 24 weeks
measure: Change in function capacity - Health Assessment questionaire
time frame: Baseline, after 6, 12 and 24 weeks
measure: Change in quality of life - Short form 36
time frame: baseline, after 6, 12 and 24 weeks
measure: Change in strength - 1 maximum repetition
time frame: baseline, after 6, 12 and 24 weeks
arm group label: Control group
arm group type: Active Comparator
description: Patient remain with their usual clinical treatment.
arm group label: Experimental group
arm group type: Experimental
description: Patients in experimental group participated in a 12-week progressive resistance training using a maximum repetition exercise in which patients performed 1 Maximum Repetition with the maximum bearable weight. Once the 1 Maximum Repetitionwas determined, training was divided into the following regimen: 2 series of 8 repetitions, the first with 50% and the second with 70% of 1 Maximum Repetition.
The exercises were knee extension and flexion and hip abduction and adduction, elbow extension and flexion, wrist extension and flexion and shoulder abduction and adduction and spine extension and flexion all performed in machines. The 1 Maximum Repetition load was reevaluated every 6 weeks.
Patient remain with their usual clinical treatment.
intervention type: Other
intervention name: Control group
arm group label: Control group
arm group label: Experimental group
other name: Clinical tretament
intervention type: Other
intervention name: Experimental group
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Felipe Martinelli Lourenzi
investigator title: PT
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid