<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/NCT03002155</url>
  </required_header>
  <id_info>
    <org_study_id>52222</org_study_id>
    <secondary_id>P30DK017047</secondary_id>
    <nct_id>NCT03002155</nct_id>
  </id_info>
  <brief_title>Effects of a Exercise Program on Health Outcomes in People With Diabetic Foot Ulcers</brief_title>
  <official_title>Effects of a Community Exercise Program on Physical, Physiological, and Psychosocial Health Outcomes in People With Diabetic Foot Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <brief_summary>
    <textblock>
      People with diabetes are at risk for life altering complications, including diabetic foot&#xD;
      ulcers. To heal a diabetic foot ulcer, people are often required to refrain from bearing&#xD;
      weight on their affected limb for months. These long periods of non-weight bearing can result&#xD;
      in severe physical deconditioning, putting these individuals at risk for further health&#xD;
      decline. The goal of this pilot, randomized controlled trial is to evaluate the effects of a&#xD;
      seated exercise program on clinically meaningful outcomes in people with diabetic foot&#xD;
      ulcers. The long-term aim of this research is to improve overall health and quality of life&#xD;
      in people with complications from diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      People with diabetes are at risk for life-altering complications and comorbidities. One of&#xD;
      the most serious complications is a diabetic foot ulcer, which significantly increases risk&#xD;
      for limb amputation. To heal a diabetic foot ulcer, patients are often instructed to refrain&#xD;
      from bearing weight on the affected limb. This non-weight bearing protocol results in&#xD;
      extended periods of inactivity that can lead to severe physical deconditioning, including&#xD;
      diminished strength, endurance, and flexibility. EnhanceFitness, a community exercise program&#xD;
      designed for older adults, holds classes that can be adapted for people who are non-weight&#xD;
      bearing due to a healing foot ulcer. These exercise classes focus specifically on strength&#xD;
      training, aerobic fitness, and stretching - activities that can counteract progressive&#xD;
      deconditioning in people with diabetic foot ulcer. Health benefits associated with exercise&#xD;
      in people with diabetes are well-established. However, for those experiencing declines in&#xD;
      health and physical function because of healing protocols for a diabetic foot ulcer, the&#xD;
      potential benefits of exercise are not yet known. The proposed project aims to address this&#xD;
      gap in diabetes research.&#xD;
&#xD;
      The long-term goal of this research is to improve the health and quality of life of people&#xD;
      with complications from diabetes. The specific goal of this project is to evaluate the effect&#xD;
      of a seated community exercise program, EnhanceFitness, on clinically-meaningful outcomes in&#xD;
      people with diabetic foot ulcers. Study investigators will recruit people with diabetic foot&#xD;
      ulcers from local wound care clinics and randomly assign them to two groups. The first group&#xD;
      will engage in EnhanceFitness, an existing community fitness program appropriate for people&#xD;
      with weight-bearing restrictions due to wound-healing protocols. The second group will&#xD;
      receive the standard of care, which does not include exercise recommendations. To assess the&#xD;
      effectiveness of the seated exercise program, the investigators will compare important health&#xD;
      outcomes between people with diabetic foot ulcers participating in EnhanceFitness and a&#xD;
      control group with diabetic foot ulcers. Specifically, the investigators will assess physical&#xD;
      and physiological outcomes, including glycated hemoglobin (HbA1c), lower-extremity strength,&#xD;
      and wound healing. The investigators will also measure psychosocial outcomes, such as&#xD;
      depression, perceived physical function, overall health, and self-reported ability to&#xD;
      continue with exercise. Further, the investigators will evaluate the feasibility of&#xD;
      conducting research assessing the effects of seated exercise in people with foot ulcers. The&#xD;
      data collected in this pilot research will be used to apply for large, extramural funding&#xD;
      that aims to mitigate physical deconditioning in people with diabetic foot ulcers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycated Hemoglobin (HbA1c) at 12-week Session</measure>
    <time_frame>12 weeks post-intervention</time_frame>
    <description>Average blood glucose over a three-month period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chair Stand Test (5x Sit-to-Stand) at 12-week Session</measure>
    <time_frame>12 weeks post-intervention</time_frame>
    <description>Measure of functional mobility and lower extremity strength. The 5x Sit-to-Stand test measures the total amount of time that it takes a individual to stand up and sit down in a chair five times. The individual is asked to stand up and sit down five times as quickly as they are able. The research staff started the stopwatch on &quot;begin&quot; and stopped timing after the individual had completed the fifth round of standing/sitting. Faster times are better, and scores are recorded in seconds.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PROMIS-Global at 12-week Session</measure>
    <time_frame>12 weeks post-intervention</time_frame>
    <description>Patient-Reported Outcome Measurement Information System (PROMIS) Global 10-item short form. Results are reported as a T-score. PROMIS-Global is a self-reported questionnaire to assess global health. T-scores are calculated for 2 subscales- physical health and mental health. A higher T-score indicates better physical health and better mental health; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores for physical health range from 16.2 to 67.7. T-scores for mental health range from 21.2 to 67.6.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS-Depression at 12 Weeks</measure>
    <time_frame>12 weeks post-intervention</time_frame>
    <description>Patient-Reported Outcome Measurement Information System (PROMIS) Depression 4-item short form. Results are reported as a T-score. PROMIS-Depression is a self-reported questionnaire to assess depression. A higher T-score indicates greater depression; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores range from 41.0 to 79.4 for the 4-item short form.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS-Physical Function</measure>
    <time_frame>12 weeks post-intervention</time_frame>
    <description>Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function 11-item short form. Results are reported as a T-score. PROMIS-Physical Function is a self-reported questionnaire to assess physical function. A higher T-score indicates better physical function; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores range from 11.9 to 57.9 for the 11-item short form.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention</measure>
    <time_frame>Through the end of study participation, approximately 12 weeks</time_frame>
    <description>Feasibility measure- did the participant attend all study data collection sessions?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence</measure>
    <time_frame>Through the end of study participation, approximately 12 weeks</time_frame>
    <description>Feasibility measure- % classes attended by participants in the intervention group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EnhanceFitness Program Evaluation</measure>
    <time_frame>12-weeks post-intervention</time_frame>
    <description>Feasibility measure, satisfaction with exercise program for participants in the intervention group. This satisfaction measure was designed by EnhanceFitness. It included 5 items, each item was rated by participants as 1 (not at all satisfied) to 5 (very satisfied). Responses for the five questions were summed and divided by 5. Scores ranged from 1-5, with better scored indicating higher satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Through the end of study participation, approximately 12 weeks</time_frame>
    <description>Feasibility measure- number of adverse events, if any, that occurred for each participant.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Recruitment</measure>
    <time_frame>At the completion of the 2-year study</time_frame>
    <description>Feasibility measure- were overall recruitment targets reached? This feasibility measure will be assessed for the overall study and not for each participant.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EnhanceFitness community exercise program</intervention_name>
    <description>Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.</description>
    <arm_group_label>Exercise</arm_group_label>
    <other_name>Seated Exercise</other_name>
    <other_name>Group exercise</other_name>
    <other_name>Fitness program</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 or more years of age&#xD;
&#xD;
          -  diagnosis of type 2 diabetes&#xD;
&#xD;
          -  undergoing treatment for a Wagner grade II, III, or IV diabetic foot ulcer&#xD;
&#xD;
          -  able to attend regular exercise classes and two data collection sessions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  medical conditions where aerobic or resistance exercise is contraindicated (e.g.,&#xD;
             uncontrolled cardiovascular problems)&#xD;
&#xD;
          -  a score of less than 18 on the Montreal Cognitive Assessment indicating moderate&#xD;
             cognitive impairment&#xD;
&#xD;
          -  response from primary physician requesting that the participant not engage in exercise&#xD;
&#xD;
          -  current participation in a regular exercise program (more than 30 minutes, more than 2&#xD;
             times a week)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sara J Morgan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwest Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <results_first_submitted>July 8, 2022</results_first_submitted>
  <results_first_submitted_qc>September 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 6, 2022</results_first_posted>
  <last_update_submitted>September 29, 2022</last_update_submitted>
  <last_update_submitted_qc>September 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Sara Morgan</investigator_full_name>
    <investigator_title>Acting Assistant Professor, Dept. of Rehabilitation Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Foot Ulcer</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 7, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03002155/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants were assigned to study group at the time that the baseline appointment was scheduled for logistical reasons (i.e., to facilitate the identification and enrollment in a community-based exercise course if the participant was allocated to the exercise group).&#xD;
34 participants were allocated to treatment group, but only 24 attended a baseline session and consented to study participation.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Exercise</title>
          <description>EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.&#xD;
EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Usual care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Found to not meet inclusion criteria during baseline session data collection.</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Exercise</title>
          <description>EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.&#xD;
EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Usual care.</description>
        </group>
        <group group_id="B3">
          <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="10"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="24"/>
          </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="59.3" spread="10.0"/>
                    <measurement group_id="B2" value="57.4" spread="11.8"/>
                    <measurement group_id="B3" value="58.2" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Gender</title>
              <category_list>
                <category>
                  <title>Women</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Men</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time since diabetes diagnosis (self-reported)</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.0" spread="14.8"/>
                    <measurement group_id="B2" value="19.1" spread="6.8"/>
                    <measurement group_id="B3" value="19.5" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.7" spread="5.5"/>
                    <measurement group_id="B2" value="36.4" spread="10.8"/>
                    <measurement group_id="B3" value="34.8" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Glycated Hemoglobin (HbA1c) at 12-week Session</title>
        <description>Average blood glucose over a three-month period</description>
        <time_frame>12 weeks post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exercise</title>
            <description>EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.&#xD;
EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>Glycated Hemoglobin (HbA1c) at 12-week Session</title>
          <description>Average blood glucose over a three-month period</description>
          <units>percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" spread="1.7"/>
                    <measurement group_id="O2" value="7.0" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.26</p_value>
            <p_value_desc>Not adjusted for multiple comparisons due to the pilot nature of the study, alpha level was 0.10.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Chair Stand Test (5x Sit-to-Stand) at 12-week Session</title>
        <description>Measure of functional mobility and lower extremity strength. The 5x Sit-to-Stand test measures the total amount of time that it takes a individual to stand up and sit down in a chair five times. The individual is asked to stand up and sit down five times as quickly as they are able. The research staff started the stopwatch on &quot;begin&quot; and stopped timing after the individual had completed the fifth round of standing/sitting. Faster times are better, and scores are recorded in seconds.</description>
        <time_frame>12 weeks post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exercise</title>
            <description>EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.&#xD;
EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>Chair Stand Test (5x Sit-to-Stand) at 12-week Session</title>
          <description>Measure of functional mobility and lower extremity strength. The 5x Sit-to-Stand test measures the total amount of time that it takes a individual to stand up and sit down in a chair five times. The individual is asked to stand up and sit down five times as quickly as they are able. The research staff started the stopwatch on &quot;begin&quot; and stopped timing after the individual had completed the fifth round of standing/sitting. Faster times are better, and scores are recorded in seconds.</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4" spread="2.8"/>
                    <measurement group_id="O2" value="17.1" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.38</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PROMIS-Global at 12-week Session</title>
        <description>Patient-Reported Outcome Measurement Information System (PROMIS) Global 10-item short form. Results are reported as a T-score. PROMIS-Global is a self-reported questionnaire to assess global health. T-scores are calculated for 2 subscales- physical health and mental health. A higher T-score indicates better physical health and better mental health; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores for physical health range from 16.2 to 67.7. T-scores for mental health range from 21.2 to 67.6.</description>
        <time_frame>12 weeks post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exercise</title>
            <description>EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.&#xD;
EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS-Global at 12-week Session</title>
          <description>Patient-Reported Outcome Measurement Information System (PROMIS) Global 10-item short form. Results are reported as a T-score. PROMIS-Global is a self-reported questionnaire to assess global health. T-scores are calculated for 2 subscales- physical health and mental health. A higher T-score indicates better physical health and better mental health; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores for physical health range from 16.2 to 67.7. T-scores for mental health range from 21.2 to 67.6.</description>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.5" spread="7.5"/>
                    <measurement group_id="O2" value="39.2" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.7" spread="10.0"/>
                    <measurement group_id="O2" value="45.7" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For PROMIS Global Physical</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.24</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For PROMIS Global Mental</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.80</p_value>
            <p_value_desc>p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PROMIS-Depression at 12 Weeks</title>
        <description>Patient-Reported Outcome Measurement Information System (PROMIS) Depression 4-item short form. Results are reported as a T-score. PROMIS-Depression is a self-reported questionnaire to assess depression. A higher T-score indicates greater depression; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores range from 41.0 to 79.4 for the 4-item short form.</description>
        <time_frame>12 weeks post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exercise</title>
            <description>EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.&#xD;
EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS-Depression at 12 Weeks</title>
          <description>Patient-Reported Outcome Measurement Information System (PROMIS) Depression 4-item short form. Results are reported as a T-score. PROMIS-Depression is a self-reported questionnaire to assess depression. A higher T-score indicates greater depression; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores range from 41.0 to 79.4 for the 4-item short form.</description>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.4" spread="8.8"/>
                    <measurement group_id="O2" value="53.8" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.81</p_value>
            <p_value_desc>p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PROMIS-Physical Function</title>
        <description>Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function 11-item short form. Results are reported as a T-score. PROMIS-Physical Function is a self-reported questionnaire to assess physical function. A higher T-score indicates better physical function; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores range from 11.9 to 57.9 for the 11-item short form.</description>
        <time_frame>12 weeks post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exercise</title>
            <description>EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.&#xD;
EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS-Physical Function</title>
          <description>Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function 11-item short form. Results are reported as a T-score. PROMIS-Physical Function is a self-reported questionnaire to assess physical function. A higher T-score indicates better physical function; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores range from 11.9 to 57.9 for the 11-item short form.</description>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.6" spread="7.2"/>
                    <measurement group_id="O2" value="37.0" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.03</p_value>
            <p_value_desc>p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Retention</title>
        <description>Feasibility measure- did the participant attend all study data collection sessions?</description>
        <time_frame>Through the end of study participation, approximately 12 weeks</time_frame>
        <population>This is a feasibility measure of how many people completed the study from baseline to 12 weeks. Thus, the number of patients that completed the baseline session was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Exercise</title>
            <description>EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.&#xD;
EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>Retention</title>
          <description>Feasibility measure- did the participant attend all study data collection sessions?</description>
          <population>This is a feasibility measure of how many people completed the study from baseline to 12 weeks. Thus, the number of patients that completed the baseline session was used.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adherence</title>
        <description>Feasibility measure- % classes attended by participants in the intervention group</description>
        <time_frame>Through the end of study participation, approximately 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exercise</title>
            <description>EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.&#xD;
EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence</title>
          <description>Feasibility measure- % classes attended by participants in the intervention group</description>
          <units>percentage of classes attended</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1" spread="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EnhanceFitness Program Evaluation</title>
        <description>Feasibility measure, satisfaction with exercise program for participants in the intervention group. This satisfaction measure was designed by EnhanceFitness. It included 5 items, each item was rated by participants as 1 (not at all satisfied) to 5 (very satisfied). Responses for the five questions were summed and divided by 5. Scores ranged from 1-5, with better scored indicating higher satisfaction.</description>
        <time_frame>12-weeks post-intervention</time_frame>
        <population>Only participants in the exercise arm who attended at least one exercise class (n=6 out of 7 total).</population>
        <group_list>
          <group group_id="O1">
            <title>Exercise</title>
            <description>EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.&#xD;
EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.</description>
          </group>
        </group_list>
        <measure>
          <title>EnhanceFitness Program Evaluation</title>
          <description>Feasibility measure, satisfaction with exercise program for participants in the intervention group. This satisfaction measure was designed by EnhanceFitness. It included 5 items, each item was rated by participants as 1 (not at all satisfied) to 5 (very satisfied). Responses for the five questions were summed and divided by 5. Scores ranged from 1-5, with better scored indicating higher satisfaction.</description>
          <population>Only participants in the exercise arm who attended at least one exercise class (n=6 out of 7 total).</population>
          <units>score 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="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events</title>
        <description>Feasibility measure- number of adverse events, if any, that occurred for each participant.</description>
        <time_frame>Through the end of study participation, approximately 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exercise</title>
            <description>EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.&#xD;
EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>Feasibility measure- number of adverse events, if any, that occurred for each participant.</description>
          <units>adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Recruitment</title>
        <description>Feasibility measure- were overall recruitment targets reached? This feasibility measure will be assessed for the overall study and not for each participant.</description>
        <time_frame>At the completion of the 2-year study</time_frame>
        <population>34 is the number randomized to group; 40 is the number that we targeted for this study</population>
        <group_list>
          <group group_id="O1">
            <title>Overall Sample</title>
            <description>All of the participants who were randomized to group out of the total number targeted for this study</description>
          </group>
        </group_list>
        <measure>
          <title>Recruitment</title>
          <description>Feasibility measure- were overall recruitment targets reached? This feasibility measure will be assessed for the overall study and not for each participant.</description>
          <population>34 is the number randomized to group; 40 is the number that we targeted for this study</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks (the duration of a participant's time in the study.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Exercise</title>
          <description>EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.&#xD;
EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Usual care.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </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="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Sara Morgan, PhD</name_or_title>
      <organization>University of Washington (affiliation)</organization>
      <phone>651-229-1719</phone>
      <email>sjmorgan@uw.edu</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/NCT03002155
org study id: 52222
secondary id: P30DK017047
nct id: NCT03002155
lead sponsor: 
collaborator: 
People with diabetes are at risk for life altering complications, including diabetic foot
      ulcers. To heal a diabetic foot ulcer, people are often required to refrain from bearing
      weight on their affected limb for months. These long periods of non-weight bearing can result
      in severe physical deconditioning, putting these individuals at risk for further health
      decline. The goal of this pilot, randomized controlled trial is to evaluate the effects of a
      seated exercise program on clinically meaningful outcomes in people with diabetic foot
      ulcers. The long-term aim of this research is to improve overall health and quality of life
      in people with complications from diabetes.
People with diabetes are at risk for life-altering complications and comorbidities. One of
      the most serious complications is a diabetic foot ulcer, which significantly increases risk
      for limb amputation. To heal a diabetic foot ulcer, patients are often instructed to refrain
      from bearing weight on the affected limb. This non-weight bearing protocol results in
      extended periods of inactivity that can lead to severe physical deconditioning, including
      diminished strength, endurance, and flexibility. EnhanceFitness, a community exercise program
      designed for older adults, holds classes that can be adapted for people who are non-weight
      bearing due to a healing foot ulcer. These exercise classes focus specifically on strength
      training, aerobic fitness, and stretching - activities that can counteract progressive
      deconditioning in people with diabetic foot ulcer. Health benefits associated with exercise
      in people with diabetes are well-established. However, for those experiencing declines in
      health and physical function because of healing protocols for a diabetic foot ulcer, the
      potential benefits of exercise are not yet known. The proposed project aims to address this
      gap in diabetes research.

      The long-term goal of this research is to improve the health and quality of life of people
      with complications from diabetes. The specific goal of this project is to evaluate the effect
      of a seated community exercise program, EnhanceFitness, on clinically-meaningful outcomes in
      people with diabetic foot ulcers. Study investigators will recruit people with diabetic foot
      ulcers from local wound care clinics and randomly assign them to two groups. The first group
      will engage in EnhanceFitness, an existing community fitness program appropriate for people
      with weight-bearing restrictions due to wound-healing protocols. The second group will
      receive the standard of care, which does not include exercise recommendations. To assess the
      effectiveness of the seated exercise program, the investigators will compare important health
      outcomes between people with diabetic foot ulcers participating in EnhanceFitness and a
      control group with diabetic foot ulcers. Specifically, the investigators will assess physical
      and physiological outcomes, including glycated hemoglobin (HbA1c), lower-extremity strength,
      and wound healing. The investigators will also measure psychosocial outcomes, such as
      depression, perceived physical function, overall health, and self-reported ability to
      continue with exercise. Further, the investigators will evaluate the feasibility of
      conducting research assessing the effects of seated exercise in people with foot ulcers. The
      data collected in this pilot research will be used to apply for large, extramural funding
      that aims to mitigate physical deconditioning in people with diabetic foot ulcers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Glycated Hemoglobin (HbA1c) at 12-week Session
time frame: 12 weeks post-intervention
description: Average blood glucose over a three-month period
measure: Chair Stand Test (5x Sit-to-Stand) at 12-week Session
time frame: 12 weeks post-intervention
description: Measure of functional mobility and lower extremity strength. The 5x Sit-to-Stand test measures the total amount of time that it takes a individual to stand up and sit down in a chair five times. The individual is asked to stand up and sit down five times as quickly as they are able. The research staff started the stopwatch on "begin" and stopped timing after the individual had completed the fifth round of standing/sitting. Faster times are better, and scores are recorded in seconds.
measure: PROMIS-Global at 12-week Session
time frame: 12 weeks post-intervention
description: Patient-Reported Outcome Measurement Information System (PROMIS) Global 10-item short form. Results are reported as a T-score. PROMIS-Global is a self-reported questionnaire to assess global health. T-scores are calculated for 2 subscales- physical health and mental health. A higher T-score indicates better physical health and better mental health; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores for physical health range from 16.2 to 67.7. T-scores for mental health range from 21.2 to 67.6.
measure: PROMIS-Depression at 12 Weeks
time frame: 12 weeks post-intervention
description: Patient-Reported Outcome Measurement Information System (PROMIS) Depression 4-item short form. Results are reported as a T-score. PROMIS-Depression is a self-reported questionnaire to assess depression. A higher T-score indicates greater depression; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores range from 41.0 to 79.4 for the 4-item short form.
measure: PROMIS-Physical Function
time frame: 12 weeks post-intervention
description: Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function 11-item short form. Results are reported as a T-score. PROMIS-Physical Function is a self-reported questionnaire to assess physical function. A higher T-score indicates better physical function; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores range from 11.9 to 57.9 for the 11-item short form.
measure: Retention
time frame: Through the end of study participation, approximately 12 weeks
description: Feasibility measure- did the participant attend all study data collection sessions?
measure: Adherence
time frame: Through the end of study participation, approximately 12 weeks
description: Feasibility measure- % classes attended by participants in the intervention group
measure: EnhanceFitness Program Evaluation
time frame: 12-weeks post-intervention
description: Feasibility measure, satisfaction with exercise program for participants in the intervention group. This satisfaction measure was designed by EnhanceFitness. It included 5 items, each item was rated by participants as 1 (not at all satisfied) to 5 (very satisfied). Responses for the five questions were summed and divided by 5. Scores ranged from 1-5, with better scored indicating higher satisfaction.
measure: Adverse Events
time frame: Through the end of study participation, approximately 12 weeks
description: Feasibility measure- number of adverse events, if any, that occurred for each participant.
measure: Recruitment
time frame: At the completion of the 2-year study
description: Feasibility measure- were overall recruitment targets reached? This feasibility measure will be assessed for the overall study and not for each participant.
arm group label: Exercise
arm group type: Experimental
description: EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks.
arm group label: Control
arm group type: No Intervention
description: Usual care.
intervention type: Other
intervention name: EnhanceFitness community exercise program
description: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.
arm group label: Exercise
other name: Seated Exercise
other name: Group exercise
other name: Fitness program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sara J Morgan, PhD
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Sara Morgan
investigator title: Acting Assistant Professor, Dept. of Rehabilitation Medicine
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Diabetes Mellitus, Type 2
mesh term: Ulcer
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 