<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/NCT03799952</url>
  </required_header>
  <id_info>
    <org_study_id>2019-01Zoom</org_study_id>
    <nct_id>NCT03799952</nct_id>
  </id_info>
  <brief_title>Zoomers for the Capital Region: A Peer-Led Exercise Program for Aging Adults</brief_title>
  <official_title>A Randomized Control Trial - Zoomers for the Capital Region: A Peer-Led Exercise Program for Aging Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Brunswick</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>New Brunswick Health Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Horizon Health Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universite de Moncton</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fitness New Brunswick</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of New Brunswick</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>
      The objective of this study is to recruit a group of older adults and study a broad set of&#xD;
      physical health, mental health, and social outcomes when participants exercise with an older&#xD;
      adult, peer-led exercise program.&#xD;
&#xD;
      The program to be evaluated is called Zoomers on the Go. It is a 12-week program which&#xD;
      involves two 60-minute sessions per week and educates participants about falls, along with&#xD;
      aerobic and resistance exercise, flexibility, and balance activities. The program is offered&#xD;
      to older adults (age 50+) and it is delivered in their community by an older adult who is&#xD;
      trained as a certified Zoomers group exercise leader.&#xD;
&#xD;
      Participants will be recruited, then randomized so that half of them can participate in a&#xD;
      Zoomers class in the spring (intervention group) while half will have to wait until the fall&#xD;
      of 2019 (control group). Pre-testing for both groups will begin around March 2019. The&#xD;
      intervention group will participate in the program for 12 weeks, then there will be&#xD;
      post-testing following this 12-weeks for both groups. Outcomes will be compared for the&#xD;
      intervention and control groups, to determine if there are changes in the data pre- to&#xD;
      post-measurements that are evident solely for the intervention group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized control trial where subjects will be randomly assigned to a&#xD;
      control or an intervention group. Participants will be recruited through general&#xD;
      advertisements (e.g. radio, newspaper, posters), in Fredericton and surrounding areas. These&#xD;
      participants will be volunteers, and no compensation will be provided besides having access&#xD;
      to a free exercise program in their community. Eligibility will be determined by the research&#xD;
      staff prior to the baseline assessment day.Eligible participants will be evaluated at an&#xD;
      initial day of testing at either a Horizon CommunityHealth Centre or at the University of New&#xD;
      Brunswick in the Cardiometabolic Exercise and Lifestyle Laboratory (CELLab). This first visit&#xD;
      will involve the confirmation of eligibility, reading and signing a consent form, and the&#xD;
      administration of the measurements discussed previously. All research staff will have&#xD;
      received the appropriate training to deliver these fitness assessments, finger pricks, and&#xD;
      interviews.&#xD;
&#xD;
      At the end of the baseline visit, research staff will randomly assign participants to the&#xD;
      intervention or control group. The participant will wear a pedometer for seven consecutive&#xD;
      days following this initial visit. The paper form for any information collected (e.g. consent&#xD;
      form) will be stored in the CELLab at UNB in a locked cabinet. The CELLab has limited access;&#xD;
      only staff has access through a password to the lab. All information will be linked to a&#xD;
      participant number for which the only linkable personal information (e.g., name, age, sex)&#xD;
      will be kept in a password protected computer and only the Principal Investigator,&#xD;
      Co-Investigators, and Research Coordinator will have access to this information. Information&#xD;
      will be stored for a maximum of 7 years.&#xD;
&#xD;
      Following this baseline assessment, participants in the intervention group will be assigned&#xD;
      to an exercise program most convenient to them. This is a 12-week exercise program, offered&#xD;
      twice a week. Full attendance is not mandatory for being a participant. This is a peer-led&#xD;
      exercise program, meaning it is instructed by a leader of similar age. This leader has&#xD;
      received extensive Fitness New Brunswick training to deliver a program aimed to reduce the&#xD;
      risk of falls and help older adults safely increase their physical activity levels. This&#xD;
      60-minute exercise program involves aerobic and resistance exercise, as well as flexibility&#xD;
      and balance activities. The program is currently designed to help individuals meet the&#xD;
      physical activity guidelines. Participants' numbers will be used to register attendance from&#xD;
      the leaders.&#xD;
&#xD;
      Following this 12-week intervention or control period, participants will repeat all the&#xD;
      baseline assessments (including questionnaires and interviews), with an exception that they&#xD;
      will not have to wear the pedometer in the follow up visit. The primary objective will be to&#xD;
      determine whether participants' experiences with the program were positive or negative, and&#xD;
      specifically identifying participants' attributions of why/how the exercise intervention&#xD;
      positively impacted their physical and/or mental health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized to a control or intervention group. The intervention group will have pre- and post-testing following 12-weeks of exercise, while the control group will have pre- and post-testing following 12-weeks of &quot;normal&quot; activity.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Balance</measure>
    <time_frame>Change pre and post (after the 12 weeks)</time_frame>
    <description>One leg stand test (seconds)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Walking Speed</measure>
    <time_frame>Change pre and post (after the 12 weeks)</time_frame>
    <description>6-minute test (meters walked)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Flexibility</measure>
    <time_frame>Change pre and post (after the 12 weeks)</time_frame>
    <description>Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of &quot;0&quot;. If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength, Arm Curl Test</measure>
    <time_frame>Change pre and post (after the 12 weeks)</time_frame>
    <description>Number of bicep curls with light weight</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength, Chair Stand Test</measure>
    <time_frame>Change pre and post (after the 12 weeks)</time_frame>
    <description>Chair stand test, number of chair stand in 30 seconds</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression, Anxiety, Stress</measure>
    <time_frame>Pre and post (before and after the 12 week exercise program)</time_frame>
    <description>Depression Anxiety Stress Scales - 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond &amp; Lovibond, 1995).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Quality of Life</measure>
    <time_frame>Pre and post (before and after the 12 week exercise program)</time_frame>
    <description>The Short Form Health Survey - 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware &amp; Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Researcher-generated Measure of Exercise Self-efficacy Based on Bandura's Concept of Self-efficacy</measure>
    <time_frame>Pre and post (before and after the 12 week exercise program)</time_frame>
    <description>The outcome measure on exercise self-efficacy (based on Bandura's concept of self-efficacy) is measured on a 1-4 scale. A higher score is more desirable than a lower score</description>
  </other_outcome>
  <other_outcome>
    <measure>Connectedness, Sense of Belonging, and Friendships</measure>
    <time_frame>Following the 12 week program</time_frame>
    <description>All collected information via interviews with participants</description>
  </other_outcome>
  <other_outcome>
    <measure>The Amount of Bodily Sway When Performing Tasks and Balancing.</measure>
    <time_frame>Pre and post (before and after the 12 week exercise program)</time_frame>
    <description>Measured by a portable biomechanical board. Can detect sway through sensors.</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine</measure>
    <time_frame>Pre and post (before and after the 12 week exercise program)</time_frame>
    <description>Blood draw via finger prick and analyzed with a Cardiochek machine&#xD;
An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine</description>
  </other_outcome>
  <other_outcome>
    <measure>Measured on a Portable Biomechanical Board.</measure>
    <time_frame>Pre and post (after the 12 weeks)</time_frame>
    <description>An individual's centre of mass as determined by sensors on a biomechanical board.</description>
  </other_outcome>
  <other_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>Pre and post (after the 12 weeks)</time_frame>
    <description>Blood pressure cuff (mmHg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Resting Heart Rate</measure>
    <time_frame>Pre and post (after the 12 weeks)</time_frame>
    <description>Radial pulse palpation (bpm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine for Cholesterol Levels</measure>
    <time_frame>Pre and post (before and after the 12 week exercise program)</time_frame>
    <description>An individual's cholesterol levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Aging</condition>
  <condition>Fall</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants are instructed to continue with their daily activities and their &quot;normal&quot; physical activity levels for 12-weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Zoomers on the Go Exercise Program</intervention_name>
    <description>60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50 years of age or older&#xD;
&#xD;
          -  Can exercise with minimal supervision (cleared for physical activity)&#xD;
&#xD;
          -  Can commit to a 12-week exercise program (2 sessions/week)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 50 years of age&#xD;
&#xD;
          -  Not cleared to perform physical activity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kinesiology Building</name>
      <address>
        <city>Fredericton</city>
        <state>New Brunswick</state>
        <zip>E3B 5A3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <results_first_submitted>December 1, 2020</results_first_submitted>
  <results_first_submitted_qc>July 13, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 14, 2021</results_first_posted>
  <last_update_submitted>July 13, 2021</last_update_submitted>
  <last_update_submitted_qc>July 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New Brunswick</investigator_affiliation>
    <investigator_full_name>Danielle Bouchard</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Older adult</keyword>
  <keyword>Peer-led exercise program</keyword>
  <keyword>Risk of falling</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT03799952/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment occurred between January and March 2019. Participants were recruited through radio advertisements, newspapers, posters, and social media. Per the participants availability they were allocated to the randomization or preferred arm.</recruitment_details>
      <pre_assignment_details>Participants were excluded if they were not cleared by the Get Active Questionnaire and did not receive clearance from their primary physician to participate</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.&#xD;
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Participants are instructed to continue with their daily activities and their &quot;normal&quot; physical activity levels for 12-weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Program was too easy, discontinued</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.&#xD;
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Participants are instructed to continue with their daily activities and their &quot;normal&quot; physical activity levels for 12-weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="29"/>
            <count group_id="B3" value="59"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.6" spread="7.2"/>
                    <measurement group_id="B2" value="66.1" spread="7.0"/>
                    <measurement group_id="B3" value="66.4" spread="7.2"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Race/Ethnicity not collected</description>
          <population>Not collected</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.9" spread="4.5"/>
                    <measurement group_id="B2" value="25.8" spread="4.8"/>
                    <measurement group_id="B3" value="27.4" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Occupation (Retired)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status (Married)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Household Income (&gt;$100,000/year)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.0"/>
                    <measurement group_id="B2" value="6.0"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Physical Activity Level (Steps/day)</title>
          <units>Steps/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6349" spread="2903"/>
                    <measurement group_id="B2" value="7221" spread="2964"/>
                    <measurement group_id="B3" value="6762" spread="2939"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Physical Activity Level (MVPA/week)</title>
          <units>Minutes of MVPA per week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68" spread="68"/>
                    <measurement group_id="B2" value="48" spread="81"/>
                    <measurement group_id="B3" value="58" spread="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Balance</title>
        <description>One leg stand test (seconds)</description>
        <time_frame>Change pre and post (after the 12 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.&#xD;
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants are instructed to continue with their daily activities and their &quot;normal&quot; physical activity levels for 12-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Balance</title>
          <description>One leg stand test (seconds)</description>
          <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="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre (eyes open)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.7" spread="14.4"/>
                    <measurement group_id="O2" value="27.9" spread="16.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post (eyes open)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.7" spread="13.4"/>
                    <measurement group_id="O2" value="29.7" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre (eyes closed)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="3.4"/>
                    <measurement group_id="O2" value="4.9" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post (eyes closed)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="3.5"/>
                    <measurement group_id="O2" value="4.4" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Walking Speed</title>
        <description>6-minute test (meters walked)</description>
        <time_frame>Change pre and post (after the 12 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.&#xD;
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants are instructed to continue with their daily activities and their &quot;normal&quot; physical activity levels for 12-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Walking Speed</title>
          <description>6-minute test (meters walked)</description>
          <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="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="476" spread="94.3"/>
                    <measurement group_id="O2" value="507" spread="90.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="539" spread="82.5"/>
                    <measurement group_id="O2" value="504" spread="79.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Flexibility</title>
        <description>Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of &quot;0&quot;. If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch.</description>
        <time_frame>Change pre and post (after the 12 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.&#xD;
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants are instructed to continue with their daily activities and their &quot;normal&quot; physical activity levels for 12-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Flexibility</title>
          <description>Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of &quot;0&quot;. If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch.</description>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.5" spread="9.9"/>
                    <measurement group_id="O2" value="-5.2" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.7" spread="9.9"/>
                    <measurement group_id="O2" value="-4.7" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Strength, Arm Curl Test</title>
        <description>Number of bicep curls with light weight</description>
        <time_frame>Change pre and post (after the 12 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.&#xD;
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants are instructed to continue with their daily activities and their &quot;normal&quot; physical activity levels for 12-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Strength, Arm Curl Test</title>
          <description>Number of bicep curls with light weight</description>
          <units>reps/30 seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.1" spread="5.1"/>
                    <measurement group_id="O2" value="17.3" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.9" spread="4.9"/>
                    <measurement group_id="O2" value="17.4" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Strength, Chair Stand Test</title>
        <description>Chair stand test, number of chair stand in 30 seconds</description>
        <time_frame>Change pre and post (after the 12 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.&#xD;
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants are instructed to continue with their daily activities and their &quot;normal&quot; physical activity levels for 12-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Strength, Chair Stand Test</title>
          <description>Chair stand test, number of chair stand in 30 seconds</description>
          <units>reps/30 seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1" spread="2.6"/>
                    <measurement group_id="O2" value="13.6" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.9" spread="4.4"/>
                    <measurement group_id="O2" value="14.1" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression, Anxiety, Stress</title>
        <description>Depression Anxiety Stress Scales - 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond &amp; Lovibond, 1995).</description>
        <time_frame>Pre and post (before and after the 12 week exercise program)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.&#xD;
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants are instructed to continue with their daily activities and their &quot;normal&quot; physical activity levels for 12-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Depression, Anxiety, Stress</title>
          <description>Depression Anxiety Stress Scales - 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond &amp; Lovibond, 1995).</description>
          <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="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre Stress (0-28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="5.6"/>
                    <measurement group_id="O2" value="5.7" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Stress (0-28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="3.9"/>
                    <measurement group_id="O2" value="8.2" spread="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre Anxiety (0-20)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="3.8"/>
                    <measurement group_id="O2" value="2.6" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Anxiety (0-20)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="3.3"/>
                    <measurement group_id="O2" value="5.0" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre Depression (0-34)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="6.3"/>
                    <measurement group_id="O2" value="3.2" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Depression (0-34)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="5.6"/>
                    <measurement group_id="O2" value="5.5" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Perceived Quality of Life</title>
        <description>The Short Form Health Survey - 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware &amp; Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent).</description>
        <time_frame>Pre and post (before and after the 12 week exercise program)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.&#xD;
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants are instructed to continue with their daily activities and their &quot;normal&quot; physical activity levels for 12-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Perceived Quality of Life</title>
          <description>The Short Form Health Survey - 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware &amp; Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent).</description>
          <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="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre Physical Functioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.0" spread="21.2"/>
                    <measurement group_id="O2" value="80.9" spread="20.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Physical Functioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.2" spread="20.2"/>
                    <measurement group_id="O2" value="80.4" spread="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre Limitations due to Physical Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.3" spread="33.9"/>
                    <measurement group_id="O2" value="81.7" spread="28.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Limitations due to Physical Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.8" spread="24.1"/>
                    <measurement group_id="O2" value="79.0" spread="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.5" spread="22.3"/>
                    <measurement group_id="O2" value="79.1" spread="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.9" spread="20.8"/>
                    <measurement group_id="O2" value="71.0" spread="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre General Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.2" spread="19.1"/>
                    <measurement group_id="O2" value="72.4" spread="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post General Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.5" spread="15.6"/>
                    <measurement group_id="O2" value="69.8" spread="16.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre Energy/Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.5" spread="19.1"/>
                    <measurement group_id="O2" value="67.4" spread="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Energy/Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.7" spread="16.3"/>
                    <measurement group_id="O2" value="65.4" spread="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre Social Functioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.2" spread="14.9"/>
                    <measurement group_id="O2" value="88.9" spread="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Social Functioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.1" spread="13.7"/>
                    <measurement group_id="O2" value="86.4" spread="19.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre Limitations Emotional Problems</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.6" spread="28.3"/>
                    <measurement group_id="O2" value="78.8" spread="33.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Limitations Emotional Problems</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.9" spread="25.3"/>
                    <measurement group_id="O2" value="84.0" spread="32.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre Emotional Well-Being</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.4" spread="13.5"/>
                    <measurement group_id="O2" value="82.5" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Emotional Well-Being</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.7" spread="10.2"/>
                    <measurement group_id="O2" value="78.7" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Researcher-generated Measure of Exercise Self-efficacy Based on Bandura's Concept of Self-efficacy</title>
        <description>The outcome measure on exercise self-efficacy (based on Bandura's concept of self-efficacy) is measured on a 1-4 scale. A higher score is more desirable than a lower score</description>
        <time_frame>Pre and post (before and after the 12 week exercise program)</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Connectedness, Sense of Belonging, and Friendships</title>
        <description>All collected information via interviews with participants</description>
        <time_frame>Following the 12 week program</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>The Amount of Bodily Sway When Performing Tasks and Balancing.</title>
        <description>Measured by a portable biomechanical board. Can detect sway through sensors.</description>
        <time_frame>Pre and post (before and after the 12 week exercise program)</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine</title>
        <description>Blood draw via finger prick and analyzed with a Cardiochek machine&#xD;
An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine</description>
        <time_frame>Pre and post (before and after the 12 week exercise program)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.&#xD;
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants are instructed to continue with their daily activities and their &quot;normal&quot; physical activity levels for 12-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine</title>
          <description>Blood draw via finger prick and analyzed with a Cardiochek machine&#xD;
An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.34" spread="0.69"/>
                    <measurement group_id="O2" value="5.61" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.70" spread="0.52"/>
                    <measurement group_id="O2" value="5.11" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Measured on a Portable Biomechanical Board.</title>
        <description>An individual's centre of mass as determined by sensors on a biomechanical board.</description>
        <time_frame>Pre and post (after the 12 weeks)</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Systolic Blood Pressure</title>
        <description>Blood pressure cuff (mmHg)</description>
        <time_frame>Pre and post (after the 12 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.&#xD;
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants are instructed to continue with their daily activities and their &quot;normal&quot; physical activity levels for 12-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure</title>
          <description>Blood pressure cuff (mmHg)</description>
          <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="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123.8" spread="12.6"/>
                    <measurement group_id="O2" value="127.5" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125.7" spread="14.9"/>
                    <measurement group_id="O2" value="124.5" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Resting Heart Rate</title>
        <description>Radial pulse palpation (bpm)</description>
        <time_frame>Pre and post (after the 12 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.&#xD;
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants are instructed to continue with their daily activities and their &quot;normal&quot; physical activity levels for 12-weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Resting Heart Rate</title>
          <description>Radial pulse palpation (bpm)</description>
          <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="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.1" spread="9.4"/>
                    <measurement group_id="O2" value="70.5" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.0" spread="7.0"/>
                    <measurement group_id="O2" value="67.2" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine for Cholesterol Levels</title>
        <description>An individual's cholesterol levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine</description>
        <time_frame>Pre and post (before and after the 12 week exercise program)</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored from the beginning of the study, through to study completion.</time_frame>
      <desc>There were no adverse events that took place from the beginning to the end of the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.&#xD;
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Participants are instructed to continue with their daily activities and their &quot;normal&quot; physical activity levels for 12-weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Danielle Bouchard</name_or_title>
      <organization>University of New Brunswick</organization>
      <phone>1 (506) 443-3908</phone>
      <email>danielle.bouchard@unb.ca</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/NCT03799952
org study id: 2019-01Zoom
nct id: NCT03799952
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to recruit a group of older adults and study a broad set of
      physical health, mental health, and social outcomes when participants exercise with an older
      adult, peer-led exercise program.

      The program to be evaluated is called Zoomers on the Go. It is a 12-week program which
      involves two 60-minute sessions per week and educates participants about falls, along with
      aerobic and resistance exercise, flexibility, and balance activities. The program is offered
      to older adults (age 50+) and it is delivered in their community by an older adult who is
      trained as a certified Zoomers group exercise leader.

      Participants will be recruited, then randomized so that half of them can participate in a
      Zoomers class in the spring (intervention group) while half will have to wait until the fall
      of 2019 (control group). Pre-testing for both groups will begin around March 2019. The
      intervention group will participate in the program for 12 weeks, then there will be
      post-testing following this 12-weeks for both groups. Outcomes will be compared for the
      intervention and control groups, to determine if there are changes in the data pre- to
      post-measurements that are evident solely for the intervention group.
This study is a randomized control trial where subjects will be randomly assigned to a
      control or an intervention group. Participants will be recruited through general
      advertisements (e.g. radio, newspaper, posters), in Fredericton and surrounding areas. These
      participants will be volunteers, and no compensation will be provided besides having access
      to a free exercise program in their community. Eligibility will be determined by the research
      staff prior to the baseline assessment day.Eligible participants will be evaluated at an
      initial day of testing at either a Horizon CommunityHealth Centre or at the University of New
      Brunswick in the Cardiometabolic Exercise and Lifestyle Laboratory (CELLab). This first visit
      will involve the confirmation of eligibility, reading and signing a consent form, and the
      administration of the measurements discussed previously. All research staff will have
      received the appropriate training to deliver these fitness assessments, finger pricks, and
      interviews.

      At the end of the baseline visit, research staff will randomly assign participants to the
      intervention or control group. The participant will wear a pedometer for seven consecutive
      days following this initial visit. The paper form for any information collected (e.g. consent
      form) will be stored in the CELLab at UNB in a locked cabinet. The CELLab has limited access;
      only staff has access through a password to the lab. All information will be linked to a
      participant number for which the only linkable personal information (e.g., name, age, sex)
      will be kept in a password protected computer and only the Principal Investigator,
      Co-Investigators, and Research Coordinator will have access to this information. Information
      will be stored for a maximum of 7 years.

      Following this baseline assessment, participants in the intervention group will be assigned
      to an exercise program most convenient to them. This is a 12-week exercise program, offered
      twice a week. Full attendance is not mandatory for being a participant. This is a peer-led
      exercise program, meaning it is instructed by a leader of similar age. This leader has
      received extensive Fitness New Brunswick training to deliver a program aimed to reduce the
      risk of falls and help older adults safely increase their physical activity levels. This
      60-minute exercise program involves aerobic and resistance exercise, as well as flexibility
      and balance activities. The program is currently designed to help individuals meet the
      physical activity guidelines. Participants' numbers will be used to register attendance from
      the leaders.

      Following this 12-week intervention or control period, participants will repeat all the
      baseline assessments (including questionnaires and interviews), with an exception that they
      will not have to wear the pedometer in the follow up visit. The primary objective will be to
      determine whether participants' experiences with the program were positive or negative, and
      specifically identifying participants' attributions of why/how the exercise intervention
      positively impacted their physical and/or mental health.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized to a control or intervention group. The intervention group will have pre- and post-testing following 12-weeks of exercise, while the control group will have pre- and post-testing following 12-weeks of "normal" activity.
primary purpose: Prevention
masking: Single (Participant)
measure: Balance
time frame: Change pre and post (after the 12 weeks)
description: One leg stand test (seconds)
measure: Walking Speed
time frame: Change pre and post (after the 12 weeks)
description: 6-minute test (meters walked)
measure: Flexibility
time frame: Change pre and post (after the 12 weeks)
description: Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch.
measure: Strength, Arm Curl Test
time frame: Change pre and post (after the 12 weeks)
description: Number of bicep curls with light weight
measure: Strength, Chair Stand Test
time frame: Change pre and post (after the 12 weeks)
description: Chair stand test, number of chair stand in 30 seconds
measure: Depression, Anxiety, Stress
time frame: Pre and post (before and after the 12 week exercise program)
description: Depression Anxiety Stress Scales - 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995).
measure: Perceived Quality of Life
time frame: Pre and post (before and after the 12 week exercise program)
description: The Short Form Health Survey - 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent).
measure: Researcher-generated Measure of Exercise Self-efficacy Based on Bandura's Concept of Self-efficacy
time frame: Pre and post (before and after the 12 week exercise program)
description: The outcome measure on exercise self-efficacy (based on Bandura's concept of self-efficacy) is measured on a 1-4 scale. A higher score is more desirable than a lower score
measure: Connectedness, Sense of Belonging, and Friendships
time frame: Following the 12 week program
description: All collected information via interviews with participants
measure: The Amount of Bodily Sway When Performing Tasks and Balancing.
time frame: Pre and post (before and after the 12 week exercise program)
description: Measured by a portable biomechanical board. Can detect sway through sensors.
measure: Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine
time frame: Pre and post (before and after the 12 week exercise program)
description: Blood draw via finger prick and analyzed with a Cardiochek machine
An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine
measure: Measured on a Portable Biomechanical Board.
time frame: Pre and post (after the 12 weeks)
description: An individual's centre of mass as determined by sensors on a biomechanical board.
measure: Systolic Blood Pressure
time frame: Pre and post (after the 12 weeks)
description: Blood pressure cuff (mmHg)
measure: Resting Heart Rate
time frame: Pre and post (after the 12 weeks)
description: Radial pulse palpation (bpm)
measure: Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine for Cholesterol Levels
time frame: Pre and post (before and after the 12 week exercise program)
description: An individual's cholesterol levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine
arm group label: Intervention
arm group type: Experimental
description: Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.
arm group label: Control
arm group type: No Intervention
description: Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks.
intervention type: Behavioral
intervention name: Zoomers on the Go Exercise Program
description: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.
arm group label: Intervention
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of New Brunswick
investigator full name: Danielle Bouchard
investigator title: Associate Professor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 