<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/NCT03757988</url>
  </required_header>
  <id_info>
    <org_study_id>18-1296</org_study_id>
    <secondary_id>1R34MH111852-01A1</secondary_id>
    <nct_id>NCT03757988</nct_id>
  </id_info>
  <brief_title>Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life</brief_title>
  <acronym>PACE-life</acronym>
  <official_title>Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: To develop and test the feasibility of an exercise intervention that combines group&#xD;
      walking, activity tracking, and heart rate monitoring, and determine the effectiveness of&#xD;
      this intervention on the physical and mental health for individuals with schizophrenia&#xD;
      spectrum disorders.&#xD;
&#xD;
      Participants: 14 individuals with schizophrenia spectrum disorders.&#xD;
&#xD;
      Procedures (methods): During the baseline assessment, subjects will be provided with a Fitbit&#xD;
      wristband and instructed how to use it. During the first group session, subjects will be&#xD;
      taught how to use their heart rate (on the Fitbit) to determine how fast subjects should walk&#xD;
      (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to&#xD;
      determine the appropriate heart from the watch, which will be used to guide the intensity of&#xD;
      the walk will be provided to subjects and reviewed at each group session. For all clinic&#xD;
      based group sessions, subjects will arrive at the STEP clinic to meet the entire group and&#xD;
      leaders and be reminded of the heart rate (HR) that corresponds with the intensity of that&#xD;
      group session. Next, the group will go outside and walk for 30 minutes. At the completion of&#xD;
      30 minutes, everyone will go back into the clinic for water and review of the walk. After the&#xD;
      second group session of each week, subjects will receive weekly progress reports of their&#xD;
      steps and minutes spent walking the prior week (obtained from Fitbit devices). During this&#xD;
      session, subjects will also set individual goals for the upcoming week for both their&#xD;
      &quot;intensity walks&quot; and total steps per day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overview of Procedures: PACE-life will be integrated into the Schizophrenia Treatment and&#xD;
      Evaluation Program (STEP) outpatient clinics in Raleigh, NC and Carrboro, NC. The group walks&#xD;
      will occur in the surrounding area around the clinics on sidewalks, bike trails, and&#xD;
      residential streets. Goal setting groups and all assessments will take place in a conference&#xD;
      room at the clinic. Goal-setting will include setting goals for the upcoming week in terms of&#xD;
      number of steps as well as how many intensity walks that individuals plan to complete.&#xD;
&#xD;
      Assessments/Measures: The exercise intervention, PACE-Life, will last for 24 weeks and&#xD;
      includes both group walks and independent walks (done at a location of the subject's&#xD;
      choosing). Participants will be asked to complete assessments at screening, baseline,&#xD;
      mid-point, post-test, and 1-month follow-up (approximately 28 weeks total).&#xD;
&#xD;
      At Screening the following measures will be examined: Demographics, the Wechsler Abbreviated&#xD;
      Scale of Intelligence (WASI), a licensed physician will complete a medical history and&#xD;
      physical exam, Physical Activity Readiness Questionnaire (PAR-Q).&#xD;
&#xD;
      At Baseline, Mid-point, Post-test, and 1-Month Follow-up the following measures will be&#xD;
      examined: Demographics, Minutes Spent Walking, the Short Form International Physical Activity&#xD;
      Questionnaire (IPAQ), Steps/day, Cardiorespiratory fitness (CRF)- CRF will be measured using&#xD;
      the 6-minute walk test (6MWT), Self-determination Basic Needs, the Basic Psychological Need&#xD;
      Scale-in General, the Basic Psychological Needs in Exercise Scale (BPNES), the Mini&#xD;
      International Neuropsychiatric Interview (MINI) (Baseline Only), Resting Systolic/Diastolic&#xD;
      Blood Pressure and resting heart rate (RHR), autonomous motivation will be measured with the&#xD;
      Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2), enjoyment of walking will be&#xD;
      measured with the Physical Activity Enjoyment Scale (PACES), the UCLA Loneliness Scale,&#xD;
      Weight, BMI, and Waist/hip Circumference.&#xD;
&#xD;
      At the conclusion of the open trial, the investigators will administer a brief questionnaire&#xD;
      to the subjects regarding satisfaction and acceptability that will have both forced choice&#xD;
      and open-ended questions.&#xD;
&#xD;
      Intervention- Groups will occur twice per week for 30 minutes for the entire intervention&#xD;
      without changes in frequency and duration. The intensity, however, of both group walks and&#xD;
      home-based walks will increase throughout this intervention in a stepwise fashion to create&#xD;
      an exercise dose response to maximize impact on CRF.&#xD;
&#xD;
      Fitbits: All participants will be provided a Fitbit that is labeled with a participant&#xD;
      number. All Fitbits are paired to a Fitbit account. Data from Fitbit devices can be synced to&#xD;
      the corresponding account and accessed through Fitbit.com. Participants will be provided&#xD;
      information about their accounts should participants want to look at the data but will be&#xD;
      asked not to change any of the settings as the investigators will be using data for tracking&#xD;
      steps/day and minutes spent walking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2018</start_date>
  <completion_date type="Actual">September 11, 2019</completion_date>
  <primary_completion_date type="Actual">September 11, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Difference in Participant's Total Distance During 6-Minute Walk From Baseline to Week 24</measure>
    <time_frame>Baseline, Post Treatment (24 weeks)</time_frame>
    <description>The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100 ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Difference in Participant's Total Distance During 6-Minute Walk From Post Treatment to Week 28</measure>
    <time_frame>Post Treatment (24 weeks), Follow-Up (Up to 28 weeks)</time_frame>
    <description>The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100 ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Difference Overall UCLA Loneliness Scale Score</measure>
    <time_frame>Up to 28 weeks</time_frame>
    <description>Mean difference in overall score from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options &quot;I often feel this way,&quot; &quot;I sometimes feel this way,&quot; &quot;I rarely feel this way,&quot; and &quot;I never feel this way.&quot; Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Difference Overall PANSS Score</measure>
    <time_frame>Up to 28 weeks</time_frame>
    <description>Mean difference in the overall score from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Difference in Body Mass Index (BMI)</measure>
    <time_frame>Up to 28 weeks</time_frame>
    <description>Mean difference in body mass index (BMI) from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Higher scores reflect worse outcomes (i.e. greater body mass).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Difference in Diastolic Blood Pressure Change</measure>
    <time_frame>Up to 28 weeks</time_frame>
    <description>Mean difference in diastolic blood pressure change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal diastolic blood pressure ranges from ≤ 70 to higher than 120 mmHg. Higher scores reflect worse outcomes (i.e., higher diastolic blood pressure).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Difference in Systolic Blood Pressure Change</measure>
    <time_frame>Up to 28 weeks</time_frame>
    <description>Mean difference in systolic blood pressure change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal systolic blood pressure ranges from ≤120 to higher than 140 mmHg. Higher scores reflect worse outcomes (i.e., higher systolic blood pressure).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Difference in Resting Heart Rate Change</measure>
    <time_frame>Up to 28 weeks</time_frame>
    <description>Mean difference in resting heart rate change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal heart rate ranges from ≤ 60 to higher than 100. Higher scores reflect worse outcomes (poorer heart condition).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Difference in Waist Circumference</measure>
    <time_frame>Up to 28 weeks</time_frame>
    <description>Mean difference in waist circumference from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal waist circumference ranges ≤ than 94cm for males and &lt; than 80 for females to higher than 102 cm for males and 88cm for females . Higher scores reflect worse outcomes (i.e. greater waist circumference = disease development risk).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Difference in Weight</measure>
    <time_frame>Up to 28 weeks</time_frame>
    <description>Mean difference in weight from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal weight ranges from 45 to 130 kilograms . Higher scores reflect worse outcomes (i.e., greater weight).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mean Difference in Weighted Average Motivation Score (Relative Autonomy Index) on the Behavioral Regulation Exercise Questionnaire (BREQ-2)</measure>
    <time_frame>Up to 28 weeks</time_frame>
    <description>Mean difference in weighted average motivation score (relative autonomy index) from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. Zero corresponds to &quot;not true for me&quot; and 4 corresponds to &quot;very true for me.&quot; Possible scores range from -24 to +20. Each subscale is calculated from averages (items scored 0-4) and then a weight is applied. Higher scores reflect better outcomes (higher autonomous motivation to exercise).</description>
  </other_outcome>
  <other_outcome>
    <measure>Mean Difference in Subscale Scores on the Basic Psychological Needs in Exercise Scale (BPNE)</measure>
    <time_frame>Up to 28 weeks</time_frame>
    <description>Mean difference in subscale scores of autonomy, relatedness, and competence from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from &quot;I don't agree at all&quot; to &quot;I completely agree.&quot; Possible scores for each subscale range from 1 to 5. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).</description>
  </other_outcome>
  <other_outcome>
    <measure>Mean Difference in Subscale Scores on the Basic Psychological Need Scale - in General (BPNS)</measure>
    <time_frame>Up to 28 weeks</time_frame>
    <description>Mean difference in subscale scores of autonomy, relatedness, and competence from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). 2. The BPNS is a 21-item self-report scale. Answers are on a 7 point Likert scale ranging from &quot;Not at all true&quot; to &quot;Very true.&quot; Possible scores for each subscale range from 1 to 7. Higher scores reflect better outcomes (i.e more psychological needs being met).</description>
  </other_outcome>
  <other_outcome>
    <measure>Median Difference in Daily Steps From Fitbit Devices</measure>
    <time_frame>Up to 28 weeks</time_frame>
    <description>Median difference in steps/day from Week 1 to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Fitbit devices record steps taken. Higher scores reflect better outcomes (higher steps/day).</description>
  </other_outcome>
  <other_outcome>
    <measure>Median Difference in Minutes Spent Walking From Fitbit Devices</measure>
    <time_frame>Up to 28 weeks</time_frame>
    <description>Median difference in weekly minutes spent walking from Week 1 to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Fitbit devices record minutes spent walking in bouts of 15 minutes. Higher scores reflect better outcomes (higher weekly minutes spent walking).</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Schizoaffective Disorder</condition>
  <condition>Brief Psychotic Disorder</condition>
  <condition>Schizophreniform Disorder</condition>
  <condition>Unspecified Schizophrenia Spectrum and Other Psychotic Disorder</condition>
  <arm_group>
    <arm_group_label>Single Arm Experimental Walking Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Intervention- PACE-Life</intervention_name>
    <description>Subjects will be provided with a Fitbit wristband and instructed how to use it. During the first group session, subjects will be taught how to use their heart rate (on the Fitbit) to determine how fast subjects should walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to determine the appropriate heart rate from the watch, which will be used to guide the intensity of the walk will be provided to subjects and reviewed at each group session. For all clinic based group sessions, subjects will arrive at the STEP clinic to meet the entire group and leaders and be reminded of the HR that corresponds with the intensity of that group session. Next, the group will go outside and walk for 30 minutes.</description>
    <arm_group_label>Single Arm Experimental Walking Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) diagnosis&#xD;
             of a Schizophrenia Spectrum Disorder (SSD) (Schizophrenia, Schizoaffective Disorder,&#xD;
             Brief Psychotic Disorder, Schizophreniform Disorder, and Unspecified Schizophrenia&#xD;
             Spectrum and Other Psychotic Disorder)&#xD;
&#xD;
          -  Between the ages of 18-65, both genders, and any ancestry;&#xD;
&#xD;
          -  Intelligence Quotient (IQ) &gt;70. IQ will be assessed using the WASI&#xD;
&#xD;
          -  No hospitalizations for psychiatric reasons in the last 3 months&#xD;
&#xD;
          -  Clinically stable (no psychiatric medication changes within the past month)&#xD;
&#xD;
          -  Are not already engaging in consistent moderate-intensity exercise (cutoff = 60&#xD;
             min/week for the past 6 months);&#xD;
&#xD;
          -  Present with no contra-indication to engage in regular moderate intensity exercise&#xD;
             based on the American College of Sports Medicine guidelines. (If an individual answers&#xD;
             yes to one item on the of the Physical Activity Readiness Questionnaire (PAR-Q), a&#xD;
             questionnaire that assesses cardiovascular risk factors, she/he will be asked to get&#xD;
             clearance from a physician prior to participating in the study)&#xD;
&#xD;
          -  Willing and able to provide informed consent. (Note: The research assistant will read&#xD;
             the consent form with the participant and ask the subject to repeat back the&#xD;
             information after each section to determine whether he/she understands the information&#xD;
             provided.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women will be excluded because pregnancy alters autonomic and immune&#xD;
             responsiveness, increase weight gain, and can influence heart rate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Penn, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Carolina Psychiatric Research Center</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <results_first_submitted>July 31, 2020</results_first_submitted>
  <results_first_submitted_qc>August 31, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 21, 2020</results_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Walking</keyword>
  <keyword>Exercise</keyword>
  <keyword>Physical Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Schizophrenia Spectrum and Other Psychotic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.</ipd_description>
    <ipd_time_frame>9 to 36 months following publication</ipd_time_frame>
    <ipd_access_criteria>Requesting investigator has appropriate approval (see above) and an executed data use/sharing agreement with UNC.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03757988/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03757988/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Single Arm Experimental Walking Group</title>
          <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot.&#xD;
Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Single Arm Experimental Walking Group</title>
          <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="38.188" spread="11.743"/>
                  </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="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian/Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Difference in Participant's Total Distance During 6-Minute Walk From Baseline to Week 24</title>
        <description>The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100 ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).</description>
        <time_frame>Baseline, Post Treatment (24 weeks)</time_frame>
        <population>Includes participants with data at Baseline and Post Treatment</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Experimental Walking Group</title>
            <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Difference in Participant's Total Distance During 6-Minute Walk From Baseline to Week 24</title>
          <description>The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100 ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).</description>
          <population>Includes participants with data at Baseline and Post Treatment</population>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.420" spread="95.490"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Difference in Participant's Total Distance During 6-Minute Walk From Post Treatment to Week 28</title>
        <description>The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100 ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).</description>
        <time_frame>Post Treatment (24 weeks), Follow-Up (Up to 28 weeks)</time_frame>
        <population>Includes participants with data at Post Treatment and Follow-Up</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Experimental Walking Group</title>
            <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot.&#xD;
Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Difference in Participant's Total Distance During 6-Minute Walk From Post Treatment to Week 28</title>
          <description>The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100 ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).</description>
          <population>Includes participants with data at Post Treatment and Follow-Up</population>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.65" spread="32.599"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Difference Overall UCLA Loneliness Scale Score</title>
        <description>Mean difference in overall score from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options &quot;I often feel this way,&quot; &quot;I sometimes feel this way,&quot; &quot;I rarely feel this way,&quot; and &quot;I never feel this way.&quot; Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).</description>
        <time_frame>Up to 28 weeks</time_frame>
        <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Experimental Walking Group</title>
            <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Difference Overall UCLA Loneliness Scale Score</title>
          <description>Mean difference in overall score from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options &quot;I often feel this way,&quot; &quot;I sometimes feel this way,&quot; &quot;I rarely feel this way,&quot; and &quot;I never feel this way.&quot; Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).</description>
          <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.133" spread="9.172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.778" spread="8.511"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Difference Overall PANSS Score</title>
        <description>Mean difference in the overall score from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).</description>
        <time_frame>Up to 28 weeks</time_frame>
        <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Experimental Walking Group</title>
            <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Difference Overall PANSS Score</title>
          <description>Mean difference in the overall score from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).</description>
          <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.267" spread="12.151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.778" spread="7.661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Difference in Body Mass Index (BMI)</title>
        <description>Mean difference in body mass index (BMI) from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Higher scores reflect worse outcomes (i.e. greater body mass).</description>
        <time_frame>Up to 28 weeks</time_frame>
        <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Experimental Walking Group</title>
            <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Difference in Body Mass Index (BMI)</title>
          <description>Mean difference in body mass index (BMI) from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Higher scores reflect worse outcomes (i.e. greater body mass).</description>
          <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.280" spread="1.736"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.022" spread="0.640"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Difference in Diastolic Blood Pressure Change</title>
        <description>Mean difference in diastolic blood pressure change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal diastolic blood pressure ranges from ≤ 70 to higher than 120 mmHg. Higher scores reflect worse outcomes (i.e., higher diastolic blood pressure).</description>
        <time_frame>Up to 28 weeks</time_frame>
        <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Experimental Walking Group</title>
            <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Difference in Diastolic Blood Pressure Change</title>
          <description>Mean difference in diastolic blood pressure change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal diastolic blood pressure ranges from ≤ 70 to higher than 120 mmHg. Higher scores reflect worse outcomes (i.e., higher diastolic blood pressure).</description>
          <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.667" spread="12.675"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.333" spread="7.566"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Difference in Systolic Blood Pressure Change</title>
        <description>Mean difference in systolic blood pressure change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal systolic blood pressure ranges from ≤120 to higher than 140 mmHg. Higher scores reflect worse outcomes (i.e., higher systolic blood pressure).</description>
        <time_frame>Up to 28 weeks</time_frame>
        <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Experimental Walking Group</title>
            <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Difference in Systolic Blood Pressure Change</title>
          <description>Mean difference in systolic blood pressure change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal systolic blood pressure ranges from ≤120 to higher than 140 mmHg. Higher scores reflect worse outcomes (i.e., higher systolic blood pressure).</description>
          <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.733" spread="10.402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.111" spread="13.110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Difference in Resting Heart Rate Change</title>
        <description>Mean difference in resting heart rate change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal heart rate ranges from ≤ 60 to higher than 100. Higher scores reflect worse outcomes (poorer heart condition).</description>
        <time_frame>Up to 28 weeks</time_frame>
        <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Experimental Walking Group</title>
            <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Difference in Resting Heart Rate Change</title>
          <description>Mean difference in resting heart rate change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal heart rate ranges from ≤ 60 to higher than 100. Higher scores reflect worse outcomes (poorer heart condition).</description>
          <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.533" spread="19.460"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.667" spread="13.115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Difference in Waist Circumference</title>
        <description>Mean difference in waist circumference from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal waist circumference ranges ≤ than 94cm for males and &lt; than 80 for females to higher than 102 cm for males and 88cm for females . Higher scores reflect worse outcomes (i.e. greater waist circumference = disease development risk).</description>
        <time_frame>Up to 28 weeks</time_frame>
        <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Experimental Walking Group</title>
            <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Difference in Waist Circumference</title>
          <description>Mean difference in waist circumference from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal waist circumference ranges ≤ than 94cm for males and &lt; than 80 for females to higher than 102 cm for males and 88cm for females . Higher scores reflect worse outcomes (i.e. greater waist circumference = disease development risk).</description>
          <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
          <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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.533" spread="9.226"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.667" spread="2.411"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Difference in Weight</title>
        <description>Mean difference in weight from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal weight ranges from 45 to 130 kilograms . Higher scores reflect worse outcomes (i.e., greater weight).</description>
        <time_frame>Up to 28 weeks</time_frame>
        <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Experimental Walking Group</title>
            <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Difference in Weight</title>
          <description>Mean difference in weight from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal weight ranges from 45 to 130 kilograms . Higher scores reflect worse outcomes (i.e., greater weight).</description>
          <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.887" spread="4.659"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.556" spread="1.384"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Mean Difference in Weighted Average Motivation Score (Relative Autonomy Index) on the Behavioral Regulation Exercise Questionnaire (BREQ-2)</title>
        <description>Mean difference in weighted average motivation score (relative autonomy index) from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. Zero corresponds to &quot;not true for me&quot; and 4 corresponds to &quot;very true for me.&quot; Possible scores range from -24 to +20. Each subscale is calculated from averages (items scored 0-4) and then a weight is applied. Higher scores reflect better outcomes (higher autonomous motivation to exercise).</description>
        <time_frame>Up to 28 weeks</time_frame>
        <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Experimental Walking Group</title>
            <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Difference in Weighted Average Motivation Score (Relative Autonomy Index) on the Behavioral Regulation Exercise Questionnaire (BREQ-2)</title>
          <description>Mean difference in weighted average motivation score (relative autonomy index) from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. Zero corresponds to &quot;not true for me&quot; and 4 corresponds to &quot;very true for me.&quot; Possible scores range from -24 to +20. Each subscale is calculated from averages (items scored 0-4) and then a weight is applied. Higher scores reflect better outcomes (higher autonomous motivation to exercise).</description>
          <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.906" spread="5.476"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.157" spread="2.379"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Mean Difference in Subscale Scores on the Basic Psychological Needs in Exercise Scale (BPNE)</title>
        <description>Mean difference in subscale scores of autonomy, relatedness, and competence from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from &quot;I don't agree at all&quot; to &quot;I completely agree.&quot; Possible scores for each subscale range from 1 to 5. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).</description>
        <time_frame>Up to 28 weeks</time_frame>
        <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Experimental Walking Group</title>
            <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Difference in Subscale Scores on the Basic Psychological Needs in Exercise Scale (BPNE)</title>
          <description>Mean difference in subscale scores of autonomy, relatedness, and competence from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from &quot;I don't agree at all&quot; to &quot;I completely agree.&quot; Possible scores for each subscale range from 1 to 5. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).</description>
          <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Autonomy scores from Baseline to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.383" spread="0.944"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relatedness scores from Baseline to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.978" spread="1.483"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Competence scores from Baseline to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.250" spread="1.225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Autonomy scores from Post Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.222" spread="0.491"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relatedness scores fromPost Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.333" spread="1.080"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Competence scores from Post Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.194" spread="0.873"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Mean Difference in Subscale Scores on the Basic Psychological Need Scale - in General (BPNS)</title>
        <description>Mean difference in subscale scores of autonomy, relatedness, and competence from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). 2. The BPNS is a 21-item self-report scale. Answers are on a 7 point Likert scale ranging from &quot;Not at all true&quot; to &quot;Very true.&quot; Possible scores for each subscale range from 1 to 7. Higher scores reflect better outcomes (i.e more psychological needs being met).</description>
        <time_frame>Up to 28 weeks</time_frame>
        <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Experimental Walking Group</title>
            <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Difference in Subscale Scores on the Basic Psychological Need Scale - in General (BPNS)</title>
          <description>Mean difference in subscale scores of autonomy, relatedness, and competence from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). 2. The BPNS is a 21-item self-report scale. Answers are on a 7 point Likert scale ranging from &quot;Not at all true&quot; to &quot;Very true.&quot; Possible scores for each subscale range from 1 to 7. Higher scores reflect better outcomes (i.e more psychological needs being met).</description>
          <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up</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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Autonomy scores from Baseline to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.067" spread="1.132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relatedness scores from Baseline to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.017" spread="0.836"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Competence scores from Baseline to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" spread="0.970"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Autonomy scores from Post Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.079" spread="1.050"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relatedness scores fromPost Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.152" spread="0.335"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Competence scores from Post Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.019" spread="0.709"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Median Difference in Daily Steps From Fitbit Devices</title>
        <description>Median difference in steps/day from Week 1 to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Fitbit devices record steps taken. Higher scores reflect better outcomes (higher steps/day).</description>
        <time_frame>Up to 28 weeks</time_frame>
        <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up. If estimate is missing for baseline or posttest, the closest point within three weeks was used as an estimate.</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Experimental Walking Group</title>
            <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Difference in Daily Steps From Fitbit Devices</title>
          <description>Median difference in steps/day from Week 1 to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Fitbit devices record steps taken. Higher scores reflect better outcomes (higher steps/day).</description>
          <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up. If estimate is missing for baseline or posttest, the closest point within three weeks was used as an estimate.</population>
          <units>steps per day</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-228" lower_limit="-14752" upper_limit="3834"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.5" lower_limit="-6223" upper_limit="4291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Median Difference in Minutes Spent Walking From Fitbit Devices</title>
        <description>Median difference in weekly minutes spent walking from Week 1 to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Fitbit devices record minutes spent walking in bouts of 15 minutes. Higher scores reflect better outcomes (higher weekly minutes spent walking).</description>
        <time_frame>Up to 28 weeks</time_frame>
        <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up. If estimate is missing for baseline or posttest, the closest point within three weeks was used as an estimate</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Experimental Walking Group</title>
            <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot. Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Difference in Minutes Spent Walking From Fitbit Devices</title>
          <description>Median difference in weekly minutes spent walking from Week 1 to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Fitbit devices record minutes spent walking in bouts of 15 minutes. Higher scores reflect better outcomes (higher weekly minutes spent walking).</description>
          <population>Includes participants with data at Baseline, Post Treatment, and Follow-Up. If estimate is missing for baseline or posttest, the closest point within three weeks was used as an estimate</population>
          <units>minutes per week</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 to Post Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-55.0" lower_limit="-1571" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Treatment to Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.5" lower_limit="-78" upper_limit="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the time of Informed Consent through follow-up, up to approximately 28 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Single Arm Experimental Walking Group</title>
          <description>This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot.&#xD;
Exercise Intervention- PACE-Life: Subjects will be provided with a Fitbit wristband and instructed how to use it.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric Hospitalization Due to Medication Non-Adherence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Psychiatric Hospitalization</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Increased Psychiatric Symptoms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </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="17"/>
              </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>Tonya Elliott</name_or_title>
      <organization>University of North Carolina at Chapel Hill</organization>
      <phone>919-966-3915</phone>
      <email>tonya_elliott@med.unc.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/NCT03757988
org study id: 18-1296
secondary id: 1R34MH111852-01A1
nct id: NCT03757988
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Purpose: To develop and test the feasibility of an exercise intervention that combines group
      walking, activity tracking, and heart rate monitoring, and determine the effectiveness of
      this intervention on the physical and mental health for individuals with schizophrenia
      spectrum disorders.

      Participants: 14 individuals with schizophrenia spectrum disorders.

      Procedures (methods): During the baseline assessment, subjects will be provided with a Fitbit
      wristband and instructed how to use it. During the first group session, subjects will be
      taught how to use their heart rate (on the Fitbit) to determine how fast subjects should walk
      (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to
      determine the appropriate heart from the watch, which will be used to guide the intensity of
      the walk will be provided to subjects and reviewed at each group session. For all clinic
      based group sessions, subjects will arrive at the STEP clinic to meet the entire group and
      leaders and be reminded of the heart rate (HR) that corresponds with the intensity of that
      group session. Next, the group will go outside and walk for 30 minutes. At the completion of
      30 minutes, everyone will go back into the clinic for water and review of the walk. After the
      second group session of each week, subjects will receive weekly progress reports of their
      steps and minutes spent walking the prior week (obtained from Fitbit devices). During this
      session, subjects will also set individual goals for the upcoming week for both their
      "intensity walks" and total steps per day.
Overview of Procedures: PACE-life will be integrated into the Schizophrenia Treatment and
      Evaluation Program (STEP) outpatient clinics in Raleigh, NC and Carrboro, NC. The group walks
      will occur in the surrounding area around the clinics on sidewalks, bike trails, and
      residential streets. Goal setting groups and all assessments will take place in a conference
      room at the clinic. Goal-setting will include setting goals for the upcoming week in terms of
      number of steps as well as how many intensity walks that individuals plan to complete.

      Assessments/Measures: The exercise intervention, PACE-Life, will last for 24 weeks and
      includes both group walks and independent walks (done at a location of the subject's
      choosing). Participants will be asked to complete assessments at screening, baseline,
      mid-point, post-test, and 1-month follow-up (approximately 28 weeks total).

      At Screening the following measures will be examined: Demographics, the Wechsler Abbreviated
      Scale of Intelligence (WASI), a licensed physician will complete a medical history and
      physical exam, Physical Activity Readiness Questionnaire (PAR-Q).

      At Baseline, Mid-point, Post-test, and 1-Month Follow-up the following measures will be
      examined: Demographics, Minutes Spent Walking, the Short Form International Physical Activity
      Questionnaire (IPAQ), Steps/day, Cardiorespiratory fitness (CRF)- CRF will be measured using
      the 6-minute walk test (6MWT), Self-determination Basic Needs, the Basic Psychological Need
      Scale-in General, the Basic Psychological Needs in Exercise Scale (BPNES), the Mini
      International Neuropsychiatric Interview (MINI) (Baseline Only), Resting Systolic/Diastolic
      Blood Pressure and resting heart rate (RHR), autonomous motivation will be measured with the
      Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2), enjoyment of walking will be
      measured with the Physical Activity Enjoyment Scale (PACES), the UCLA Loneliness Scale,
      Weight, BMI, and Waist/hip Circumference.

      At the conclusion of the open trial, the investigators will administer a brief questionnaire
      to the subjects regarding satisfaction and acceptability that will have both forced choice
      and open-ended questions.

      Intervention- Groups will occur twice per week for 30 minutes for the entire intervention
      without changes in frequency and duration. The intensity, however, of both group walks and
      home-based walks will increase throughout this intervention in a stepwise fashion to create
      an exercise dose response to maximize impact on CRF.

      Fitbits: All participants will be provided a Fitbit that is labeled with a participant
      number. All Fitbits are paired to a Fitbit account. Data from Fitbit devices can be synced to
      the corresponding account and accessed through Fitbit.com. Participants will be provided
      information about their accounts should participants want to look at the data but will be
      asked not to change any of the settings as the investigators will be using data for tracking
      steps/day and minutes spent walking.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Difference in Participant's Total Distance During 6-Minute Walk From Baseline to Week 24
time frame: Baseline, Post Treatment (24 weeks)
description: The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100 ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).
measure: Mean Difference in Participant's Total Distance During 6-Minute Walk From Post Treatment to Week 28
time frame: Post Treatment (24 weeks), Follow-Up (Up to 28 weeks)
description: The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100 ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).
measure: Mean Difference Overall UCLA Loneliness Scale Score
time frame: Up to 28 weeks
description: Mean difference in overall score from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).
measure: Mean Difference Overall PANSS Score
time frame: Up to 28 weeks
description: Mean difference in the overall score from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).
measure: Mean Difference in Body Mass Index (BMI)
time frame: Up to 28 weeks
description: Mean difference in body mass index (BMI) from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Higher scores reflect worse outcomes (i.e. greater body mass).
measure: Mean Difference in Diastolic Blood Pressure Change
time frame: Up to 28 weeks
description: Mean difference in diastolic blood pressure change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal diastolic blood pressure ranges from ≤ 70 to higher than 120 mmHg. Higher scores reflect worse outcomes (i.e., higher diastolic blood pressure).
measure: Mean Difference in Systolic Blood Pressure Change
time frame: Up to 28 weeks
description: Mean difference in systolic blood pressure change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal systolic blood pressure ranges from ≤120 to higher than 140 mmHg. Higher scores reflect worse outcomes (i.e., higher systolic blood pressure).
measure: Mean Difference in Resting Heart Rate Change
time frame: Up to 28 weeks
description: Mean difference in resting heart rate change from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal heart rate ranges from ≤ 60 to higher than 100. Higher scores reflect worse outcomes (poorer heart condition).
measure: Mean Difference in Waist Circumference
time frame: Up to 28 weeks
description: Mean difference in waist circumference from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal waist circumference ranges ≤ than 94cm for males and < than 80 for females to higher than 102 cm for males and 88cm for females . Higher scores reflect worse outcomes (i.e. greater waist circumference = disease development risk).
measure: Mean Difference in Weight
time frame: Up to 28 weeks
description: Mean difference in weight from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Normal weight ranges from 45 to 130 kilograms . Higher scores reflect worse outcomes (i.e., greater weight).
measure: Mean Difference in Weighted Average Motivation Score (Relative Autonomy Index) on the Behavioral Regulation Exercise Questionnaire (BREQ-2)
time frame: Up to 28 weeks
description: Mean difference in weighted average motivation score (relative autonomy index) from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. Zero corresponds to "not true for me" and 4 corresponds to "very true for me." Possible scores range from -24 to +20. Each subscale is calculated from averages (items scored 0-4) and then a weight is applied. Higher scores reflect better outcomes (higher autonomous motivation to exercise).
measure: Mean Difference in Subscale Scores on the Basic Psychological Needs in Exercise Scale (BPNE)
time frame: Up to 28 weeks
description: Mean difference in subscale scores of autonomy, relatedness, and competence from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from "I don't agree at all" to "I completely agree." Possible scores for each subscale range from 1 to 5. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).
measure: Mean Difference in Subscale Scores on the Basic Psychological Need Scale - in General (BPNS)
time frame: Up to 28 weeks
description: Mean difference in subscale scores of autonomy, relatedness, and competence from Baseline to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). 2. The BPNS is a 21-item self-report scale. Answers are on a 7 point Likert scale ranging from "Not at all true" to "Very true." Possible scores for each subscale range from 1 to 7. Higher scores reflect better outcomes (i.e more psychological needs being met).
measure: Median Difference in Daily Steps From Fitbit Devices
time frame: Up to 28 weeks
description: Median difference in steps/day from Week 1 to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Fitbit devices record steps taken. Higher scores reflect better outcomes (higher steps/day).
measure: Median Difference in Minutes Spent Walking From Fitbit Devices
time frame: Up to 28 weeks
description: Median difference in weekly minutes spent walking from Week 1 to Post Treatment (24 weeks) and to Follow-Up Visit (up to 28 weeks). Fitbit devices record minutes spent walking in bouts of 15 minutes. Higher scores reflect better outcomes (higher weekly minutes spent walking).
arm group label: Single Arm Experimental Walking Group
arm group type: Experimental
description: This is a pilot project with one single group that will be evaluated on the adherence to a walking protocol (Exercise Intervention- PACE-Life). Subjects will be walking two times a week under the supervision of the psychiatric clinic. In addition, subjects will be encouraged to add walking on their own on the days when subjects are not exercising under the supervision of the clinic. This pilot will be used to inform the final design of the subsequent randomized clinical trial that will be implemented following this pilot.
intervention type: Behavioral
intervention name: Exercise Intervention- PACE-Life
description: Subjects will be provided with a Fitbit wristband and instructed how to use it. During the first group session, subjects will be taught how to use their heart rate (on the Fitbit) to determine how fast subjects should walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to determine the appropriate heart rate from the watch, which will be used to guide the intensity of the walk will be provided to subjects and reviewed at each group session. For all clinic based group sessions, subjects will arrive at the STEP clinic to meet the entire group and leaders and be reminded of the HR that corresponds with the intensity of that group session. Next, the group will go outside and walk for 30 minutes.
arm group label: Single Arm Experimental Walking Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: David Penn, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Mental Disorders
mesh term: Psychotic Disorders
mesh term: Schizophrenia Spectrum and Other Psychotic Disorders
sharing ipd: Yes
ipd description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
ipd time frame: 9 to 36 months following publication
ipd access criteria: Requesting investigator has appropriate approval (see above) and an executed data use/sharing agreement with UNC.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 