<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/NCT01690273</url>
  </required_header>
  <id_info>
    <org_study_id>8206212</org_study_id>
    <nct_id>NCT01690273</nct_id>
  </id_info>
  <brief_title>Exercise Therapy Program in Ankylosing Spondylitis Patients</brief_title>
  <official_title>Effect of Two Exercise Therapy Program With and Without Elastic Resistance in Ankylosing Spondylitis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mobility exercises are used in Ankylosing Spondylitis (AS) patients to preserve and restore&#xD;
      axial mobility, but there are no data regarding a specific rehabilitation program that&#xD;
      includes flexibility alone and its association with resistance exercises in AS patients with&#xD;
      stable disease activity. So, we assessed the effects of two exercise programs in terms of&#xD;
      mobility, functional capacity, quality of life and disease activity in AS patients. Methods.&#xD;
      Fifty-five sedentary AS patients with a Bath Ankylosing Spondylitis Activity Index (BASDAI)&#xD;
      &lt;4 were included.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The AS patients were randomly assigned into three groups, to receive a mobility exercise&#xD;
      program (M) or mobility plus elastic resistance exercise program (M+R) or no exercise (C).&#xD;
      The exercises group sessions were conducted twice per week for 16 weeks. This supervised&#xD;
      program comprised 30 minutes of outdoor stretching and mobility exercises for the spine and&#xD;
      limbs (M). After the flexibility program, M+R group carry out more 30 minutes of elastic&#xD;
      resistance exercises. The mobility, disease activity and functional parameters were evaluated&#xD;
      at baseline and after 16 weeks, with the evaluator blinded to the treatment group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">June 2013</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>FUNCTIONAL INDEX</measure>
    <time_frame>Baseline and 16 Weeks</time_frame>
    <description>BASFI - Bath ankylosing spondylitis functional index. A scale from 0 to 10 (lower scores means better functional capacity), results are measured by mean and standard deviation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mobility Index</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Bath ankylosing spondylitis motion index. A mean of five mobility measures committed by Ankylosing Spondylitis disease. Higher results means higher limitations in mobility (units of measure from 0 to 10)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Activity Index</measure>
    <time_frame>Baseline and 16 Weeks</time_frame>
    <description>BASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ankylosing Spondylitis Disease Activity Scale -Disease Activity</measure>
    <time_frame>Baseline and 16 Weeks</time_frame>
    <description>Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Global Evaluation Self Reported</measure>
    <time_frame>Baseline and 16 Weeks</time_frame>
    <description>Bath Ankylosing Spondylitis Global is a self reported global score varying from 0 to 10. Higher scores means worst health evaluation. Expressed by means and standard deviation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Thoracolumbar Mobility</measure>
    <time_frame>Baseline and 16 Weeks</time_frame>
    <description>Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Scale</measure>
    <time_frame>Baseline and 16 Weeks</time_frame>
    <description>Pain was evaluated in a visual analogue scale (VAS) from 0 to 10. higher scores means much pain. Data was expressed by means and standard deviation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stiffness Scale</measure>
    <time_frame>Baseline and 16 Weeks</time_frame>
    <description>Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness. Data are expressed by mean and SD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form-12 (PCS)</measure>
    <time_frame>Baseline and 16 Weeks</time_frame>
    <description>Quality of life was analyzed in a physical component score varying from 0 (lowest level of health) to 100 (highest level of health) scale. Data are expressed by mean and SD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form-12 (MCS)</measure>
    <time_frame>Baseline and 16 Weeks</time_frame>
    <description>Quality of life was analyzed in a mental component score varying from 0 (lowest level of health) to 100 (highest level of health). Data are expressed by mean and SD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MASES</measure>
    <time_frame>Baseline and 16 Weeks</time_frame>
    <description>Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) score varying from 0 to 13. Where 0 is no painful point reported and 13 is all tender points reported as painful. Data are expressed by means and standard deviation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chin-coronoid Distance</measure>
    <time_frame>Baseline and 16 Weeks</time_frame>
    <description>lateral rotation of the head (chin-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral rotation mobility. Data are expressed by means and standard deviation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tragus-coronoid Distance</measure>
    <time_frame>Baseline and 16 Weeks</time_frame>
    <description>lateral flexion of the head (tragus-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral flexion mobility of the head.Data are expressed by means and standard deviation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Finger Floor Distance</measure>
    <time_frame>Baseline and 16 Weeks</time_frame>
    <description>Distance between third finger of the hand and the floor while in lumbar flexion. It was measured with a tape in centimeters. Highest score means better torso flexion mobility. Data are expressed by means and standard deviation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chest Expansion</measure>
    <time_frame>Baseline and 16 Weeks</time_frame>
    <description>Chest expansion was measured with a tape in centimeters between inspiration and breathing exhaling. Highest score means better chest expansion. Data are expressed by means and standard deviation.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Ankylosing Spondylitis</condition>
  <arm_group>
    <arm_group_label>ankylosing spondylitis control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mobility exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mobility exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mobility and elastic resistance exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AS patients was submitted to a program mobility exercise plus elastic resistance exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mobility exercise</intervention_name>
    <description>30 minutes, twice a week</description>
    <arm_group_label>mobility exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mobility and elastic resistance exercise</intervention_name>
    <description>30 minutes, twice a week each exercises group. (total 1 hour)</description>
    <arm_group_label>mobility and elastic resistance exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ankylosing spondylitis patient&#xD;
&#xD;
          -  Basdai index lower than 4&#xD;
&#xD;
          -  Physical inactive&#xD;
&#xD;
          -  Functional class I to III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fibromyalgia&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
&#xD;
          -  Pain Visual Analogue Scale (&quot;VAS&quot;) over 8&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana Lucia Pinto, Phd</last_name>
    <role>Study Chair</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Yigit S, Sahin Z, Demir SE, Aytac DH. Home-based exercise therapy in ankylosing spondylitis: short-term prospective study in patients receiving tumor necrosis factor alpha inhibitors. Rheumatol Int. 2013 Jan;33(1):71-7. doi: 10.1007/s00296-011-2344-6. Epub 2012 Jan 5.</citation>
    <PMID>22218641</PMID>
  </results_reference>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <results_first_submitted>January 27, 2016</results_first_submitted>
  <results_first_submitted_qc>August 27, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 20, 2016</results_first_posted>
  <last_update_submitted>August 27, 2016</last_update_submitted>
  <last_update_submitted_qc>August 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Andrea Lopes Gallinaro</investigator_full_name>
    <investigator_title>MASTER</investigator_title>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>mobility</keyword>
  <keyword>strengthening</keyword>
  <keyword>physiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>paper is been written</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Two hundred nine consecutive patients from the division of rheumatology outpatient clinic of the university hospital (Clinics Hospital of University Medicine School of Sao Paulo) diagnosed with AS according to the modified New York criteria, were invited to participate. Fifty Five individuals were randomly allocated into three groups</recruitment_details>
      <pre_assignment_details>Seventy patients did not accepted and 84 did not followed inclusion criteria. Fifty five were allocated into three groups after following the inclusion criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Ankylosing Spondylitis Control</title>
          <description>control group, no intervention in ankylosing spondylitis patients</description>
        </group>
        <group group_id="P2">
          <title>Mobility in Ankylosing Spondylitis</title>
          <description>mobility exercises&#xD;
mobility exercise: 30 minutes, twice a week</description>
        </group>
        <group group_id="P3">
          <title>Mobility and Elastic Resistance Exercise in AS</title>
          <description>mobility, plus elastic resistance exercises&#xD;
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ankylosing Spondylitis Control</title>
          <description>Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.</description>
        </group>
        <group group_id="B2">
          <title>Stretching in AS</title>
          <description>stretching exercises&#xD;
stretching exercise: 30 minutes, twice a week for sixteen weeks.</description>
        </group>
        <group group_id="B3">
          <title>Elastic Resistance Exercise in AS</title>
          <description>stretching and elastic resistance exercises&#xD;
stretching and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="20"/>
            <count group_id="B4" value="55"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.1" spread="10.8"/>
                    <measurement group_id="B2" value="49.2" spread="13.1"/>
                    <measurement group_id="B3" value="48.3" spread="11.1"/>
                    <measurement group_id="B4" value="48.2" spread="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>FUNCTIONAL INDEX</title>
        <description>BASFI - Bath ankylosing spondylitis functional index. A scale from 0 to 10 (lower scores means better functional capacity), results are measured by mean and standard deviation.</description>
        <time_frame>Baseline and 16 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankylosing Spondylitis Control</title>
            <description>control group with AS patients and no exercise</description>
          </group>
          <group group_id="O2">
            <title>Mobility in AS</title>
            <description>mobility exercises&#xD;
mobility exercise: 30 minutes, twice a week</description>
          </group>
          <group group_id="O3">
            <title>Mobility Plus Elastic Resistance Exercise in AS</title>
            <description>mobility and elastic resistance exercises&#xD;
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)</description>
          </group>
        </group_list>
        <measure>
          <title>FUNCTIONAL INDEX</title>
          <description>BASFI - Bath ankylosing spondylitis functional index. A scale from 0 to 10 (lower scores means better functional capacity), results are measured by mean and standard deviation.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="2.7"/>
                    <measurement group_id="O2" value="4.3" spread="1.9"/>
                    <measurement group_id="O3" value="3.2" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="2.5"/>
                    <measurement group_id="O2" value="4.0" spread="2.2"/>
                    <measurement group_id="O3" value="2.2" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.13</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.99</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.11</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9913</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0427</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1856</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mobility Index</title>
        <description>Bath ankylosing spondylitis motion index. A mean of five mobility measures committed by Ankylosing Spondylitis disease. Higher results means higher limitations in mobility (units of measure from 0 to 10)</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankylosing Spondylitis Control</title>
            <description>control group with AS patients and no exercise</description>
          </group>
          <group group_id="O2">
            <title>Mobility in AS</title>
            <description>mobility exercises&#xD;
mobility exercise: 30 minutes, twice a week</description>
          </group>
          <group group_id="O3">
            <title>Mobility Plus Elastic Resistance Exercise in AS</title>
            <description>mobility and elastic resistance exercises&#xD;
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)</description>
          </group>
        </group_list>
        <measure>
          <title>Mobility Index</title>
          <description>Bath ankylosing spondylitis motion index. A mean of five mobility measures committed by Ankylosing Spondylitis disease. Higher results means higher limitations in mobility (units of measure from 0 to 10)</description>
          <units>units on a scale from 0 to 10</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="2"/>
                    <measurement group_id="O2" value="5.3" spread="2"/>
                    <measurement group_id="O3" value="4.5" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="2.0"/>
                    <measurement group_id="O2" value="4.8" spread="2.1"/>
                    <measurement group_id="O3" value="4.0" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.04</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.935</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.876</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Disease Activity Index</title>
        <description>BASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD)</description>
        <time_frame>Baseline and 16 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankylosing Spondylitis Control</title>
            <description>Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.</description>
          </group>
          <group group_id="O2">
            <title>Mobility in AS</title>
            <description>mobility exercises&#xD;
mobility exercise: 30 minutes, twice a week for sixteen weeks.</description>
          </group>
          <group group_id="O3">
            <title>Mobility Plus Elastic Resistance Exercise in AS</title>
            <description>mobility and elastic resistance exercises&#xD;
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Activity Index</title>
          <description>BASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="1"/>
                    <measurement group_id="O2" value="2.6" spread="1.1"/>
                    <measurement group_id="O3" value="2.1" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="2.0"/>
                    <measurement group_id="O2" value="2.9" spread="1.4"/>
                    <measurement group_id="O3" value="1.7" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.87</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.83</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.989</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.022</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.119</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ankylosing Spondylitis Disease Activity Scale -Disease Activity</title>
        <description>Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD</description>
        <time_frame>Baseline and 16 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankylosing Spondylitis Control</title>
            <description>control group AS patients with no exercise</description>
          </group>
          <group group_id="O2">
            <title>Mobility in AS</title>
            <description>mobility exercises&#xD;
mobility exercise: 30 minutes, twice a week</description>
          </group>
          <group group_id="O3">
            <title>Mobility Plus Elastic Resistance Exercise in AS</title>
            <description>mobility and elastic resistance exercises&#xD;
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)</description>
          </group>
        </group_list>
        <measure>
          <title>Ankylosing Spondylitis Disease Activity Scale -Disease Activity</title>
          <description>Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="0.7"/>
                    <measurement group_id="O2" value="1.7" spread="0.7"/>
                    <measurement group_id="O3" value="1.5" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="0.8"/>
                    <measurement group_id="O2" value="1.6" spread="0.7"/>
                    <measurement group_id="O3" value="1.4" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.09</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.99</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.94</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.213</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.007</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.900</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Global Evaluation Self Reported</title>
        <description>Bath Ankylosing Spondylitis Global is a self reported global score varying from 0 to 10. Higher scores means worst health evaluation. Expressed by means and standard deviation.</description>
        <time_frame>Baseline and 16 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankylosing Spondylitis Control</title>
            <description>control group AS patients with no exercise</description>
          </group>
          <group group_id="O2">
            <title>Mobility in AS</title>
            <description>mobility exercises&#xD;
mobility exercise: 30 minutes, twice a week</description>
          </group>
          <group group_id="O3">
            <title>Mobility Plus Elastic Resistance Exercise in AS</title>
            <description>mobility and elastic resistance exercises&#xD;
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)</description>
          </group>
        </group_list>
        <measure>
          <title>Global Evaluation Self Reported</title>
          <description>Bath Ankylosing Spondylitis Global is a self reported global score varying from 0 to 10. Higher scores means worst health evaluation. Expressed by means and standard deviation.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="1.9"/>
                    <measurement group_id="O2" value="5.0" spread="2.3"/>
                    <measurement group_id="O3" value="4.1" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" spread="2.4"/>
                    <measurement group_id="O2" value="4.7" spread="2.2"/>
                    <measurement group_id="O3" value="3.4" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.99</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.69</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.874</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.057</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.526</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Thoracolumbar Mobility</title>
        <description>Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation</description>
        <time_frame>Baseline and 16 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankylosing Spondylitis Control</title>
            <description>control group AS patients with no exercise</description>
          </group>
          <group group_id="O2">
            <title>Mobility in AS</title>
            <description>mobility exercises&#xD;
mobility exercise: 30 minutes, twice a week</description>
          </group>
          <group group_id="O3">
            <title>Mobility Plus Elastic Resistance Exercise in AS</title>
            <description>mobility and elastic resistance exercises&#xD;
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)</description>
          </group>
        </group_list>
        <measure>
          <title>Thoracolumbar Mobility</title>
          <description>Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation</description>
          <units>Centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="1.5"/>
                    <measurement group_id="O2" value="1.4" spread="0.9"/>
                    <measurement group_id="O3" value="1.6" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="0.9"/>
                    <measurement group_id="O2" value="2.1" spread="1.0"/>
                    <measurement group_id="O3" value="2.6" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.853</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.016</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.889</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.098</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.645</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Scale</title>
        <description>Pain was evaluated in a visual analogue scale (VAS) from 0 to 10. higher scores means much pain. Data was expressed by means and standard deviation.</description>
        <time_frame>Baseline and 16 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankylosing Spondylitis Control</title>
            <description>control group AS patients with no exercise</description>
          </group>
          <group group_id="O2">
            <title>Mobility in AS</title>
            <description>mobility exercises&#xD;
mobility exercise: 30 minutes, twice a week</description>
          </group>
          <group group_id="O3">
            <title>Mobility Plus Elastic Resistance Exercise in AS</title>
            <description>mobility and elastic resistance exercises&#xD;
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Scale</title>
          <description>Pain was evaluated in a visual analogue scale (VAS) from 0 to 10. higher scores means much pain. Data was expressed by means and standard deviation.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="1.8"/>
                    <measurement group_id="O2" value="2.5" spread="1.9"/>
                    <measurement group_id="O3" value="2.0" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="2.7"/>
                    <measurement group_id="O2" value="2.4" spread="1.5"/>
                    <measurement group_id="O3" value="2.0" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.07</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.13</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.97</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.338</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.476</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stiffness Scale</title>
        <description>Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness. Data are expressed by mean and SD.</description>
        <time_frame>Baseline and 16 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankylosing Spondylitis Control</title>
            <description>control group AS patients with no exercise</description>
          </group>
          <group group_id="O2">
            <title>Mobility in AS</title>
            <description>mobility exercises&#xD;
mobility exercise: 30 minutes, twice a week</description>
          </group>
          <group group_id="O3">
            <title>Mobility Plus Elastic Resistance Exercise in AS</title>
            <description>mobility and elastic resistance exercises&#xD;
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)</description>
          </group>
        </group_list>
        <measure>
          <title>Stiffness Scale</title>
          <description>Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness. Data are expressed by mean and SD.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="2.6"/>
                    <measurement group_id="O2" value="3.1" spread="2.2"/>
                    <measurement group_id="O3" value="3.1" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="2.6"/>
                    <measurement group_id="O2" value="4.2" spread="2.0"/>
                    <measurement group_id="O3" value="2.8" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.88</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.99</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.995</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.985</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Short Form-12 (PCS)</title>
        <description>Quality of life was analyzed in a physical component score varying from 0 (lowest level of health) to 100 (highest level of health) scale. Data are expressed by mean and SD.</description>
        <time_frame>Baseline and 16 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankylosing Spondylitis Control</title>
            <description>control group AS patients with no exercise</description>
          </group>
          <group group_id="O2">
            <title>Mobility in AS</title>
            <description>mobility exercises&#xD;
mobility exercise: 30 minutes, twice a week</description>
          </group>
          <group group_id="O3">
            <title>Mobility Plus Elastic Resistance Exercise in AS</title>
            <description>mobility and elastic resistance exercises&#xD;
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)</description>
          </group>
        </group_list>
        <measure>
          <title>Short Form-12 (PCS)</title>
          <description>Quality of life was analyzed in a physical component score varying from 0 (lowest level of health) to 100 (highest level of health) scale. Data are expressed by mean and SD.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.3" spread="7.4"/>
                    <measurement group_id="O2" value="38.8" spread="8.0"/>
                    <measurement group_id="O3" value="43.9" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.9" spread="8.8"/>
                    <measurement group_id="O2" value="40.9" spread="10.6"/>
                    <measurement group_id="O3" value="44.8" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.99</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.999</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.900</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.739</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Short Form-12 (MCS)</title>
        <description>Quality of life was analyzed in a mental component score varying from 0 (lowest level of health) to 100 (highest level of health). Data are expressed by mean and SD.</description>
        <time_frame>Baseline and 16 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankylosing Spondylitis Control</title>
            <description>control group AS patients with no exercise</description>
          </group>
          <group group_id="O2">
            <title>Mobility in AS</title>
            <description>mobility exercises&#xD;
mobility exercise: 30 minutes, twice a week</description>
          </group>
          <group group_id="O3">
            <title>Mobility Plus Elastic Resistance Exercise in AS</title>
            <description>mobility and elastic resistance exercises&#xD;
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)</description>
          </group>
        </group_list>
        <measure>
          <title>Short Form-12 (MCS)</title>
          <description>Quality of life was analyzed in a mental component score varying from 0 (lowest level of health) to 100 (highest level of health). Data are expressed by mean and SD.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.8" spread="10.7"/>
                    <measurement group_id="O2" value="45.7" spread="11.6"/>
                    <measurement group_id="O3" value="47.1" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.1" spread="9.7"/>
                    <measurement group_id="O2" value="46.0" spread="10.8"/>
                    <measurement group_id="O3" value="51.6" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.37</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.618</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.689</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MASES</title>
        <description>Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) score varying from 0 to 13. Where 0 is no painful point reported and 13 is all tender points reported as painful. Data are expressed by means and standard deviation</description>
        <time_frame>Baseline and 16 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankylosing Spondylitis Control</title>
            <description>control group AS patients with no exercise</description>
          </group>
          <group group_id="O2">
            <title>Mobility in AS</title>
            <description>mobility exercises&#xD;
mobility exercise: 30 minutes, twice a week</description>
          </group>
          <group group_id="O3">
            <title>Mobility Plus Elastic Resistance Exercise in AS</title>
            <description>mobility and elastic resistance exercises&#xD;
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)</description>
          </group>
        </group_list>
        <measure>
          <title>MASES</title>
          <description>Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) score varying from 0 to 13. Where 0 is no painful point reported and 13 is all tender points reported as painful. Data are expressed by means and standard deviation</description>
          <units>Number of painful tender points</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="1.4"/>
                    <measurement group_id="O2" value="1.5" spread="3.4"/>
                    <measurement group_id="O3" value="0.8" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="1.9"/>
                    <measurement group_id="O2" value="1.1" spread="1.7"/>
                    <measurement group_id="O3" value="0.7" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.8</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.97</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.99</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.999</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.929</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.980</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Chin-coronoid Distance</title>
        <description>lateral rotation of the head (chin-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral rotation mobility. Data are expressed by means and standard deviation</description>
        <time_frame>Baseline and 16 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankylosing Spondylitis Control</title>
            <description>control group AS patients with no exercise</description>
          </group>
          <group group_id="O2">
            <title>Mobility in AS</title>
            <description>mobility exercises&#xD;
mobility exercise: 30 minutes, twice a week</description>
          </group>
          <group group_id="O3">
            <title>Mobility Plus Elastic Resistance Exercise in AS</title>
            <description>mobility and elastic resistance exercises&#xD;
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)</description>
          </group>
        </group_list>
        <measure>
          <title>Chin-coronoid Distance</title>
          <description>lateral rotation of the head (chin-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral rotation mobility. Data are expressed by means and standard deviation</description>
          <units>Centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9" spread="2.7"/>
                    <measurement group_id="O2" value="14.2" spread="5.6"/>
                    <measurement group_id="O3" value="10.9" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" spread="2.5"/>
                    <measurement group_id="O2" value="9.5" spread="2.3"/>
                    <measurement group_id="O3" value="9.2" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.350</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.997</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.970</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.999</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tragus-coronoid Distance</title>
        <description>lateral flexion of the head (tragus-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral flexion mobility of the head.Data are expressed by means and standard deviation</description>
        <time_frame>Baseline and 16 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankylosing Spondylitis Control</title>
            <description>control group AS patients with no exercise</description>
          </group>
          <group group_id="O2">
            <title>Mobility in AS</title>
            <description>mobility exercises&#xD;
mobility exercise: 30 minutes, twice a week</description>
          </group>
          <group group_id="O3">
            <title>Mobility Plus Elastic Resistance Exercise in AS</title>
            <description>mobility and elastic resistance exercises&#xD;
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)</description>
          </group>
        </group_list>
        <measure>
          <title>Tragus-coronoid Distance</title>
          <description>lateral flexion of the head (tragus-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral flexion mobility of the head.Data are expressed by means and standard deviation</description>
          <units>Centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9" spread="2.7"/>
                    <measurement group_id="O2" value="12.3" spread="4.0"/>
                    <measurement group_id="O3" value="9.7" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" spread="2.2"/>
                    <measurement group_id="O2" value="9.0" spread="2.0"/>
                    <measurement group_id="O3" value="8.8" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.997</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.503</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.814</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.643</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.999</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Finger Floor Distance</title>
        <description>Distance between third finger of the hand and the floor while in lumbar flexion. It was measured with a tape in centimeters. Highest score means better torso flexion mobility. Data are expressed by means and standard deviation</description>
        <time_frame>Baseline and 16 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankylosing Spondylitis Control</title>
            <description>control group AS patients with no exercise</description>
          </group>
          <group group_id="O2">
            <title>Mobility in AS</title>
            <description>mobility exercises&#xD;
mobility exercise: 30 minutes, twice a week</description>
          </group>
          <group group_id="O3">
            <title>Mobility Plus Elastic Resistance Exercise in AS</title>
            <description>mobility and elastic resistance exercises&#xD;
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)</description>
          </group>
        </group_list>
        <measure>
          <title>Finger Floor Distance</title>
          <description>Distance between third finger of the hand and the floor while in lumbar flexion. It was measured with a tape in centimeters. Highest score means better torso flexion mobility. Data are expressed by means and standard deviation</description>
          <units>Centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.6" spread="13.3"/>
                    <measurement group_id="O2" value="27.1" spread="13.7"/>
                    <measurement group_id="O3" value="23.7" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.5" spread="13.6"/>
                    <measurement group_id="O2" value="24.2" spread="13.3"/>
                    <measurement group_id="O3" value="20.3" spread="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.787</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.408</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.157</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.835</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.256</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.935</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Chest Expansion</title>
        <description>Chest expansion was measured with a tape in centimeters between inspiration and breathing exhaling. Highest score means better chest expansion. Data are expressed by means and standard deviation.</description>
        <time_frame>Baseline and 16 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankylosing Spondylitis Control</title>
            <description>control group AS patients with no exercise</description>
          </group>
          <group group_id="O2">
            <title>Mobility in AS</title>
            <description>mobility exercises&#xD;
mobility exercise: 30 minutes, twice a week</description>
          </group>
          <group group_id="O3">
            <title>Mobility Plus Elastic Resistance Exercise in AS</title>
            <description>mobility and elastic resistance exercises&#xD;
mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)</description>
          </group>
        </group_list>
        <measure>
          <title>Chest Expansion</title>
          <description>Chest expansion was measured with a tape in centimeters between inspiration and breathing exhaling. Highest score means better chest expansion. Data are expressed by means and standard deviation.</description>
          <units>Centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="1.3"/>
                    <measurement group_id="O2" value="2.8" spread="1.2"/>
                    <measurement group_id="O3" value="3.6" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="1.9"/>
                    <measurement group_id="O2" value="3.3" spread="1.2"/>
                    <measurement group_id="O3" value="4.3" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.978</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.169</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.993</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.105</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.335</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>during 16 weeks</time_frame>
      <desc>A baseline evaluation was done and another after 16 weeks</desc>
      <group_list>
        <group group_id="E1">
          <title>Ankylosing Spondylitis Control</title>
          <description>Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.</description>
        </group>
        <group group_id="E2">
          <title>Stretching in AS</title>
          <description>stretching exercises&#xD;
stretching exercise: 30 minutes, twice a week for sixteen weeks.</description>
        </group>
        <group group_id="E3">
          <title>Elastic Resistance Exercise in AS</title>
          <description>stretching and elastic resistance exercises&#xD;
stretching and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Andrea Lopes Gallinaro; Researcher</name_or_title>
      <organization>Universidade Sao Paulo</organization>
      <phone>55112601 ext 8022</phone>
      <email>algallinaro@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01690273
org study id: 8206212
nct id: NCT01690273
lead sponsor: 
has dmc: No
Mobility exercises are used in Ankylosing Spondylitis (AS) patients to preserve and restore
      axial mobility, but there are no data regarding a specific rehabilitation program that
      includes flexibility alone and its association with resistance exercises in AS patients with
      stable disease activity. So, we assessed the effects of two exercise programs in terms of
      mobility, functional capacity, quality of life and disease activity in AS patients. Methods.
      Fifty-five sedentary AS patients with a Bath Ankylosing Spondylitis Activity Index (BASDAI)
      <4 were included.
The AS patients were randomly assigned into three groups, to receive a mobility exercise
      program (M) or mobility plus elastic resistance exercise program (M+R) or no exercise (C).
      The exercises group sessions were conducted twice per week for 16 weeks. This supervised
      program comprised 30 minutes of outdoor stretching and mobility exercises for the spine and
      limbs (M). After the flexibility program, M+R group carry out more 30 minutes of elastic
      resistance exercises. The mobility, disease activity and functional parameters were evaluated
      at baseline and after 16 weeks, with the evaluator blinded to the treatment group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: FUNCTIONAL INDEX
time frame: Baseline and 16 Weeks
description: BASFI - Bath ankylosing spondylitis functional index. A scale from 0 to 10 (lower scores means better functional capacity), results are measured by mean and standard deviation.
measure: Mobility Index
time frame: Baseline and 16 weeks
description: Bath ankylosing spondylitis motion index. A mean of five mobility measures committed by Ankylosing Spondylitis disease. Higher results means higher limitations in mobility (units of measure from 0 to 10)
measure: Disease Activity Index
time frame: Baseline and 16 Weeks
description: BASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD)
measure: Ankylosing Spondylitis Disease Activity Scale -Disease Activity
time frame: Baseline and 16 Weeks
description: Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD
measure: Global Evaluation Self Reported
time frame: Baseline and 16 Weeks
description: Bath Ankylosing Spondylitis Global is a self reported global score varying from 0 to 10. Higher scores means worst health evaluation. Expressed by means and standard deviation.
measure: Thoracolumbar Mobility
time frame: Baseline and 16 Weeks
description: Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation
measure: Pain Scale
time frame: Baseline and 16 Weeks
description: Pain was evaluated in a visual analogue scale (VAS) from 0 to 10. higher scores means much pain. Data was expressed by means and standard deviation.
measure: Stiffness Scale
time frame: Baseline and 16 Weeks
description: Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness. Data are expressed by mean and SD.
measure: Short Form-12 (PCS)
time frame: Baseline and 16 Weeks
description: Quality of life was analyzed in a physical component score varying from 0 (lowest level of health) to 100 (highest level of health) scale. Data are expressed by mean and SD.
measure: Short Form-12 (MCS)
time frame: Baseline and 16 Weeks
description: Quality of life was analyzed in a mental component score varying from 0 (lowest level of health) to 100 (highest level of health). Data are expressed by mean and SD.
measure: MASES
time frame: Baseline and 16 Weeks
description: Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) score varying from 0 to 13. Where 0 is no painful point reported and 13 is all tender points reported as painful. Data are expressed by means and standard deviation
measure: Chin-coronoid Distance
time frame: Baseline and 16 Weeks
description: lateral rotation of the head (chin-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral rotation mobility. Data are expressed by means and standard deviation
measure: Tragus-coronoid Distance
time frame: Baseline and 16 Weeks
description: lateral flexion of the head (tragus-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral flexion mobility of the head.Data are expressed by means and standard deviation
measure: Finger Floor Distance
time frame: Baseline and 16 Weeks
description: Distance between third finger of the hand and the floor while in lumbar flexion. It was measured with a tape in centimeters. Highest score means better torso flexion mobility. Data are expressed by means and standard deviation
measure: Chest Expansion
time frame: Baseline and 16 Weeks
description: Chest expansion was measured with a tape in centimeters between inspiration and breathing exhaling. Highest score means better chest expansion. Data are expressed by means and standard deviation.
arm group label: ankylosing spondylitis control
arm group type: No Intervention
description: control group
arm group label: mobility exercise
arm group type: Experimental
description: mobility exercises
arm group label: mobility and elastic resistance exercise
arm group type: Experimental
description: AS patients was submitted to a program mobility exercise plus elastic resistance exercises
intervention type: Other
intervention name: mobility exercise
description: 30 minutes, twice a week
arm group label: mobility exercise
intervention type: Other
intervention name: mobility and elastic resistance exercise
description: 30 minutes, twice a week each exercises group. (total 1 hour)
arm group label: mobility and elastic resistance exercise
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ana Lucia Pinto, Phd
role: Study Chair
affiliation: University of Sao Paulo
facility: 
country: Brazil
citation: Yigit S, Sahin Z, Demir SE, Aytac DH. Home-based exercise therapy in ankylosing spondylitis: short-term prospective study in patients receiving tumor necrosis factor alpha inhibitors. Rheumatol Int. 2013 Jan;33(1):71-7. doi: 10.1007/s00296-011-2344-6. Epub 2012 Jan 5.
PMID: 22218641
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Andrea Lopes Gallinaro
investigator title: MASTER
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
sharing ipd: Yes
ipd description: paper is been written
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 