<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/NCT03292510</url>
  </required_header>
  <id_info>
    <org_study_id>G-16-00013978</org_study_id>
    <nct_id>NCT03292510</nct_id>
  </id_info>
  <brief_title>Getting Older Adults OUTdoors (GO-OUT)</brief_title>
  <official_title>Getting Older Adults OUTdoors (GO-OUT): A Randomized Controlled Trial of a Theory-based, Task-oriented, Outdoor Walking Program for Older Adults With Difficulty Walking Outdoors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>McGill University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Toronto</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Community walking is an issue that older adults with chronic conditions have described as&#xD;
      important to participation in the community. Walking outside the home is a universally&#xD;
      accessible form of physical activity that has multiple health benefits. Walking for 150&#xD;
      minutes per week can help reduce the risk of cardiovascular disease, hypertension, stroke,&#xD;
      diabetes, osteoporosis, and depression, as well as falls. Practice walking across roads,&#xD;
      slopes and curbs, while talking, and dealing with crowds and traffic, is safe and feasible&#xD;
      and can improve confidence, balance and walking ability. Being physically active outdoors in&#xD;
      nature appears to improve mental health more than being active indoors. Despite these health&#xD;
      benefits, the majority of older Canadians do not walk outside on a regular basis. Barriers to&#xD;
      walking outside include fear, physical disability due to chronic disease, the appropriateness&#xD;
      of footwear and walking aids, and the physical environment, such as uneven pavement, weather&#xD;
      and temperature. To date, the best strategy for getting people to walk outdoors regularly is&#xD;
      unknown. The investigators propose to evaluate the effectiveness of a dynamic 1-day workshop,&#xD;
      at which older adults who infrequently walk outdoors learn strategies to facilitate outdoor&#xD;
      walking, such as appropriate use of footwear, ambulatory aids and equipment, goal setting,&#xD;
      and practice skills related to increasing outdoor walking. The workshop will be compared to&#xD;
      the workshop plus involvement in a walking group for 3 months. Outcomes include outdoor&#xD;
      walking activity, total physical activity, walking ability, participation, and health-related&#xD;
      quality of life. Each participant will have four evaluations: baseline, 3, 5.5 and 12 months&#xD;
      later. The investigators will interview select participants at 6 and 12 months to ask them&#xD;
      about their opinions of what worked and didn't work. Increasing outdoor walking is expected&#xD;
      to improve health and well-being, and help people live independently in the community for&#xD;
      longer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Inability to walk outdoors restricts full participation in physical activity and&#xD;
      community living for older adults that can reduce health-related quality of life (HRQL).&#xD;
      Older adults report limited outdoor walking with only 8% achieving the Canadian&#xD;
      recommendation for older adults of 150 minutes of moderate-to-vigorous (MV) intensity&#xD;
      physical activity per week. Known barriers to walking outside include fear, physical&#xD;
      disability due to chronic disease, the appropriateness of footwear and walking aids, the&#xD;
      physical environment, weather and temperature. Group practice walking outdoors in locations&#xD;
      with variable environmental challenges has the potential to improve physical ability,&#xD;
      confidence, outdoor and overall physical activity and social participation. The extent to&#xD;
      which it is safe and feasible to implement this intervention in people with varying degrees&#xD;
      of physical ability, preferences for where to walk, neighbourhood walkability, and to measure&#xD;
      outdoor walking activity, is unclear.&#xD;
&#xD;
      Objectives: In older adults with a limitation in outdoor community mobility:&#xD;
&#xD;
        1. To estimate the extent to which a 1-day educational workshop and 10-week outdoor&#xD;
           mobility program (GO-OUT intervention) compared to the workshop and weekly reminders&#xD;
           improves outdoor walking activity (primary outcome) and secondary outcomes of physical&#xD;
           activity, lifespace mobility, participation, HRQL, balance, leg strength, walking&#xD;
           self-efficacy, walking speed, walking distance/endurance, and mood over 12 months.&#xD;
&#xD;
        2. To explore participants' perceptions of intended and unintended consequences of the&#xD;
           interventions, potent intervention components, mechanisms of effect, modifying&#xD;
           influences of disability level, sex,neighborhood walkability, weather, car access, and&#xD;
           study site, and recommendations for future program delivery models.&#xD;
&#xD;
      Approaches and Methods:Study Design: A 2-group mixed methods stratified randomized controlled&#xD;
      trial following CONSORT criteria is proposed. Group allocation will be concealed and outcome&#xD;
      evaluation blinded. The trial will be run at 4 sites (Edmonton, Winnipeg, Toronto, Montreal)&#xD;
      to accrue a sufficient sample size, optimize the external validity of the results to urban&#xD;
      centres variable in population size, weather conditions, and environmental barriers, and&#xD;
      build capacity across 4 provinces to support potential implementation. Following a baseline&#xD;
      assessment, eligible participants will be stratified by site, and randomly assigned to&#xD;
      receive the 1-day educational workshop and 3-month outdoor mobility program (GO-OUT&#xD;
      intervention) or the 1-day workshop plus weekly reminders. Follow-up evaluations will occur&#xD;
      at 3, 5.5 and 12 months from baseline. A sub-sample of participants from the GO-OUT and&#xD;
      workshop groups at each site will participate in face-to-face interviews at 6 and 12 months&#xD;
      to explore their experiences. Interventions and assessments are designed to be implemented in&#xD;
      'good weather' months, to avoid the potential negative effect of season on the primary&#xD;
      outcome of outdoor walking activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2018</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</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>Experimental: GO-OUT program An outdoor walking workshop with stations to learn various outdoor walking skills and information, followed by a supervised, group based outdoor walking program, twice a week for 60 minutes, for 10 weeks.&#xD;
Intervention: Other: GO-OUT program Active Comparator: Task-oriented outdoor walking workshop An outdoor walking workshop with stations to learn various outdoor walking skills and information.&#xD;
Intervention: Other: Task-oriented outdoor walking workshop</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>A 2-group mixed methods stratified randomized controlled trial following CONSORT criteria is proposed. Group allocation will be concealed and outcome evaluation blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in average number of minutes per week spent walking outdoors</measure>
    <time_frame>baseline, 3, 5.5, 12 months</time_frame>
    <description>The ActiGraph GT3X+ activity monitor (www.actigraphcorp.com/products/wgt3x-monitor/, ActiGraph, Pensacola, FL) and Qstarz BT-Q1000XT A-GPS Travel Recorder (http://www.qstarz.com/Products/GPS%20Products/BT-Q1000XT-F.htm) will be worn by each participant, clipped onto their waist band over the right hip during waking hours for 8 consecutive days at each evaluation timepoint (baseline, 3, 5.5, and 12 months).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the mean time per week spent walking outdoors on the Community Health Activities Model Program for Seniors (CHAMPS) Questionnaire</measure>
    <time_frame>baseline, 3, 5.5, 12 months</time_frame>
    <description>The Community Health Activities Model Program for Seniors (CHAMPS) questionnaire is a measure of participation, physical activity and outdoor walking. Participants self-report time spent performing various social, leisure, and physical activities in a typical week during the last 4 weeks. Total time spent per week in outdoor walking will be determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the mean time per week spent in meaningful activity on the Community Health Activities Model Program for Seniors (CHAMPS) Questionnaire</measure>
    <time_frame>baseline, 3, 5.5, 12 months</time_frame>
    <description>The Community Health Activities Model Program for Seniors (CHAMPS) questionnaire is a measure of participation, physical activity and outdoor walking. Participants self-report time spent performing various social, leisure, and physical activities in a typical week during the last 4 weeks. Total time spent per week in any activity will be determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the mean self-reported time per week spent in moderate- to vigorous-intensity physical activity on the Community Health Activities Model Program for Seniors (CHAMPS) Questionnaire</measure>
    <time_frame>baseline, 3, 5.5, 12 months</time_frame>
    <description>The Community Health Activities Model Program for Seniors (CHAMPS) questionnaire is a measure of participation, physical activity and outdoor walking. Participants self-report time spent performing various social, leisure, and physical activities in a typical week during the last 4 weeks. Total time spent per week in moderate- to vigorous-intensity aerobic physical activity is determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the mean time per week spent in moderate- to vigorous-intensity physical activity directly measured using ActiGraph and GPS devices</measure>
    <time_frame>baseline, 3, 5.5, 12 months</time_frame>
    <description>The ActiGraph GT3X+ activity monitor (www.actigraphcorp.com/products/wgt3x-monitor/, ActiGraph, Pensacola, FL) and Qstarz BT-Q1000XT A-GPS Travel Recorder (http://www.qstarz.com/Products/GPS%20Products/BT-Q1000XT-F.htm) will be worn by each participant, clipped onto their waist band over the right hip during waking hours for 8 consecutive days at each evaluation timepoint (baseline, 3, 5.5, and 12 months).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the mean score on the Life Space Assessment Questionnaire</measure>
    <time_frame>baseline, 3, 5.5, 12 months</time_frame>
    <description>The Life Space Assessment Questionnaire is a measure of life space mobility. Total scores can range from 0 (totally bed bound) to 120 (travels out of the city every day without assistance). The score indicates level, degree of independence and frequency of attainment of mobility in five living spaces in the past four weeks: rooms in the house, the area outside the house, places in the neighbourhood, places outside the neighbourhood but within the city, and places outside the city.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the mean scores on the Patient Generated Index (PGI)</measure>
    <time_frame>baseline, 3, 5.5, 12 months</time_frame>
    <description>For the PGI, participants select five most important areas of their life that are affected by their health, then rates the degree to which each area is affected from 0 (worst level imaginable) to 10 (best level of function possible).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the mean scores on the Research ANd Development-36 (RAND-36)</measure>
    <time_frame>baseline, 3, 5.5, 12 months</time_frame>
    <description>The RAND-36 is a 36-item self-report measure of 8 health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain and general health perceptions. Total scores range from 0 to 100, where higher scores represent the most optimal health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the mean total score on the Mini Balance Evaluations Systems Test (Mini BESTest)</measure>
    <time_frame>baseline, 3, 5.5, 12 months</time_frame>
    <description>The Mini BESTest is a measure of balance. Total scores can range from 0 to 28 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the mean number of sit-to-stands completed in 30 seconds in the 30-second Sit to Stand Test.</measure>
    <time_frame>baseline, 3, 5.5, 12 months</time_frame>
    <description>The 30-second Sit to Stand Test is a measure of lower extremity strength. The minimum score is 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the mean score on the Ambulatory Self-Confidence Questionnaire</measure>
    <time_frame>baseline, 3, 5.5, 12 months</time_frame>
    <description>The Ambulatory Self-Confidence Questionnaire is a 22-item questionnaire to measure self-efficacy to walk at home and/or in the community. The total score is the mean of item-level scores and can range from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the mean walking speed on the 10m Walk Test, completed at a comfortable pace and a fast pace</measure>
    <time_frame>baseline, 3, 5.5, 12 months</time_frame>
    <description>The 10m Walk Test is a measure of the participant's walking speed at a comfortable and fast pace. The participant uses his/her usual assistive device(s) and corrective eyewear.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the mean distance (in metres) walked on the 6-Minute Walk Test</measure>
    <time_frame>baseline, 3, 5.5, 12 months</time_frame>
    <description>The 6-Minute Walk Test is a measure of walking endurance. Participants walk for 6 minutes unassisted using his/her usual mobility device. The distance walked in metres in 6 minutes is recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in resting heart rate</measure>
    <time_frame>baseline, 3, 5.5, 12 months</time_frame>
    <description>Heart rate (HR) is taken at rest after sitting for at least 5 minutes with back supported and feet flat on the floor. HR is taken through manual palpation of the radial artery for 1 minute. Resting HR is part of the screening for participants prior to administering the 6-Minute Walk Test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in resting blood pressure</measure>
    <time_frame>baseline, 3, 5.5, 12 months</time_frame>
    <description>Blood pressure (BP) is taken at rest after sitting for at least 5 minutes with back supported and feet flat on the floor. BP is taken using a manual or automated documented. Resting BP is part of the screening for participants prior to administering the 6-Minute Walk Test.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">191</enrollment>
  <condition>Older Adults With Decreased Outdoor Walking Ability</condition>
  <arm_group>
    <arm_group_label>GO-OUT Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants attend 1-day walking workshop followed by a 3-month outdoor walking group intervention, twice weekly for 60-minutes. The same activities are completed during both sessions within the same week. Each session includes a 10-minute warm-up, a distance walk, practice of a specific outdoor walking skill, a distance walk, and a 10-minute cool down. The warm up and cool down include stretching, functional strengthening exercises and balance exercises taught during the workshop. The program incorporates the principles of task-specific training by emphasizing repetitive practice of progressively more difficult outdoor walking tasks. The outdoor walking program is conducted in one or more large park settings given the mental health benefits of exercising in a natural environment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Workshop Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The 1-day workshop will be 5 hours with breaks. Participants will complete a series of stations learning information, strategies and skills related to safely walking outdoors. Stations include: pedometer use; walking pole use; footwear; footcare; fall prevention; balance exercises; proper use of walking aids; correct posture; self-management of exercise intensity; goal setting; and walking safely outdoors. Participants will receive a workbook with Canadian Physical Activity Guidelines, benefits of outdoor walking, information for each workshop station and a pedometer. Participants will use the workbook as an information resource and to record their community ambulation goals, planning routes, and walking time. All participants will be encouraged to walk outside with a partner, for safety.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GO-OUT Group</intervention_name>
    <description>Following a baseline assessment, eligible participants will be stratified by site, and randomly assigned to receive the 1-day educational workshop and 3-month outdoor mobility program (GO-OUT intervention). Follow-up evaluations will occur at 3, 5.5 and 12 months from baseline.</description>
    <arm_group_label>GO-OUT Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Workshop Group</intervention_name>
    <description>the 1-day workshop plus reminders. Follow-up evaluations will occur at 3, 5.5 and 12 months from baseline</description>
    <arm_group_label>Workshop Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. older adults defined as age 65 years or older;&#xD;
&#xD;
          2. living independently in the community;&#xD;
&#xD;
          3. ambulatory defined as self-reported ability to walk at least one block (~50 m)&#xD;
             continuously on a flat surface with or without a walking aid and without supervision;&#xD;
&#xD;
          4. self-reported difficulty walking in the outdoor community environment (this could&#xD;
             include physical impairments or decreased confidence);&#xD;
&#xD;
          5. willingness to sign a liability waiver (required at three sites) or send a letter to&#xD;
             their physician (required at one site) regarding clearance to exercise;&#xD;
&#xD;
          6. mental competency defined by a score of at least 18 out of 22 on the Mini-Mental State&#xD;
             Exam telephone version;&#xD;
&#xD;
          7. available for a scheduled workshop and at least 5 of 10 weeks of the outdoor walking&#xD;
             program; and&#xD;
&#xD;
          8. ability to speak and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. physically active defined as self-reported participation in physical activities, such&#xD;
             as walking and playing golf, 150 min per week;&#xD;
&#xD;
          2. currently receiving rehabilitation treatment, such as physical or occupational&#xD;
             therapy, for goals related to walking (self-report);&#xD;
&#xD;
          3. at high falls risk defined by meeting one or more of the following American Geriatric&#xD;
             Society criteria: (A) ≥2 falls in the last 12 months or presents with an acute fall;&#xD;
             (B) cardiac, respiratory, peripheral vascular or other health conditions that would&#xD;
             prevent safe and full participation in the interventions (self-report); (C) postural&#xD;
             hypotension defined as a drop in systolic BP of &gt;20 mm Hg or a drop in diastolic BP of&#xD;
             &gt;10 mm Hg taken after lying supine for 5 min and after standing for 2 min; (D) resting&#xD;
             HR &lt;45 or &gt;100 beats per minute; and (E) severe limitation in visual acuity defined as&#xD;
             self-reported difficulty reading the newspaper while wearing regular reading glasses&#xD;
             or bifocals, or self-reported inability to distinguish a person's facial features from&#xD;
             across a room while wearing glasses.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy Salbach, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Knowledge to Action Lab, Department of Physical Therapy, University of Toronto</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>January 8, 2021</last_update_submitted>
  <last_update_submitted_qc>January 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Toronto</investigator_affiliation>
    <investigator_full_name>Dr. Nancy Salbach</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03292510
org study id: G-16-00013978
nct id: NCT03292510
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Community walking is an issue that older adults with chronic conditions have described as
      important to participation in the community. Walking outside the home is a universally
      accessible form of physical activity that has multiple health benefits. Walking for 150
      minutes per week can help reduce the risk of cardiovascular disease, hypertension, stroke,
      diabetes, osteoporosis, and depression, as well as falls. Practice walking across roads,
      slopes and curbs, while talking, and dealing with crowds and traffic, is safe and feasible
      and can improve confidence, balance and walking ability. Being physically active outdoors in
      nature appears to improve mental health more than being active indoors. Despite these health
      benefits, the majority of older Canadians do not walk outside on a regular basis. Barriers to
      walking outside include fear, physical disability due to chronic disease, the appropriateness
      of footwear and walking aids, and the physical environment, such as uneven pavement, weather
      and temperature. To date, the best strategy for getting people to walk outdoors regularly is
      unknown. The investigators propose to evaluate the effectiveness of a dynamic 1-day workshop,
      at which older adults who infrequently walk outdoors learn strategies to facilitate outdoor
      walking, such as appropriate use of footwear, ambulatory aids and equipment, goal setting,
      and practice skills related to increasing outdoor walking. The workshop will be compared to
      the workshop plus involvement in a walking group for 3 months. Outcomes include outdoor
      walking activity, total physical activity, walking ability, participation, and health-related
      quality of life. Each participant will have four evaluations: baseline, 3, 5.5 and 12 months
      later. The investigators will interview select participants at 6 and 12 months to ask them
      about their opinions of what worked and didn't work. Increasing outdoor walking is expected
      to improve health and well-being, and help people live independently in the community for
      longer.
Background: Inability to walk outdoors restricts full participation in physical activity and
      community living for older adults that can reduce health-related quality of life (HRQL).
      Older adults report limited outdoor walking with only 8% achieving the Canadian
      recommendation for older adults of 150 minutes of moderate-to-vigorous (MV) intensity
      physical activity per week. Known barriers to walking outside include fear, physical
      disability due to chronic disease, the appropriateness of footwear and walking aids, the
      physical environment, weather and temperature. Group practice walking outdoors in locations
      with variable environmental challenges has the potential to improve physical ability,
      confidence, outdoor and overall physical activity and social participation. The extent to
      which it is safe and feasible to implement this intervention in people with varying degrees
      of physical ability, preferences for where to walk, neighbourhood walkability, and to measure
      outdoor walking activity, is unclear.

      Objectives: In older adults with a limitation in outdoor community mobility:

        1. To estimate the extent to which a 1-day educational workshop and 10-week outdoor
           mobility program (GO-OUT intervention) compared to the workshop and weekly reminders
           improves outdoor walking activity (primary outcome) and secondary outcomes of physical
           activity, lifespace mobility, participation, HRQL, balance, leg strength, walking
           self-efficacy, walking speed, walking distance/endurance, and mood over 12 months.

        2. To explore participants' perceptions of intended and unintended consequences of the
           interventions, potent intervention components, mechanisms of effect, modifying
           influences of disability level, sex,neighborhood walkability, weather, car access, and
           study site, and recommendations for future program delivery models.

      Approaches and Methods:Study Design: A 2-group mixed methods stratified randomized controlled
      trial following CONSORT criteria is proposed. Group allocation will be concealed and outcome
      evaluation blinded. The trial will be run at 4 sites (Edmonton, Winnipeg, Toronto, Montreal)
      to accrue a sufficient sample size, optimize the external validity of the results to urban
      centres variable in population size, weather conditions, and environmental barriers, and
      build capacity across 4 provinces to support potential implementation. Following a baseline
      assessment, eligible participants will be stratified by site, and randomly assigned to
      receive the 1-day educational workshop and 3-month outdoor mobility program (GO-OUT
      intervention) or the 1-day workshop plus weekly reminders. Follow-up evaluations will occur
      at 3, 5.5 and 12 months from baseline. A sub-sample of participants from the GO-OUT and
      workshop groups at each site will participate in face-to-face interviews at 6 and 12 months
      to explore their experiences. Interventions and assessments are designed to be implemented in
      'good weather' months, to avoid the potential negative effect of season on the primary
      outcome of outdoor walking activity.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Experimental: GO-OUT program An outdoor walking workshop with stations to learn various outdoor walking skills and information, followed by a supervised, group based outdoor walking program, twice a week for 60 minutes, for 10 weeks.
Intervention: Other: GO-OUT program Active Comparator: Task-oriented outdoor walking workshop An outdoor walking workshop with stations to learn various outdoor walking skills and information.
Intervention: Other: Task-oriented outdoor walking workshop
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: A 2-group mixed methods stratified randomized controlled trial following CONSORT criteria is proposed. Group allocation will be concealed and outcome evaluation blinded
measure: Change in average number of minutes per week spent walking outdoors
time frame: baseline, 3, 5.5, 12 months
description: The ActiGraph GT3X+ activity monitor (www.actigraphcorp.com/products/wgt3x-monitor/, ActiGraph, Pensacola, FL) and Qstarz BT-Q1000XT A-GPS Travel Recorder (http://www.qstarz.com/Products/GPS%20Products/BT-Q1000XT-F.htm) will be worn by each participant, clipped onto their waist band over the right hip during waking hours for 8 consecutive days at each evaluation timepoint (baseline, 3, 5.5, and 12 months).
measure: Change in the mean time per week spent walking outdoors on the Community Health Activities Model Program for Seniors (CHAMPS) Questionnaire
time frame: baseline, 3, 5.5, 12 months
description: The Community Health Activities Model Program for Seniors (CHAMPS) questionnaire is a measure of participation, physical activity and outdoor walking. Participants self-report time spent performing various social, leisure, and physical activities in a typical week during the last 4 weeks. Total time spent per week in outdoor walking will be determined.
measure: Change in the mean time per week spent in meaningful activity on the Community Health Activities Model Program for Seniors (CHAMPS) Questionnaire
time frame: baseline, 3, 5.5, 12 months
description: The Community Health Activities Model Program for Seniors (CHAMPS) questionnaire is a measure of participation, physical activity and outdoor walking. Participants self-report time spent performing various social, leisure, and physical activities in a typical week during the last 4 weeks. Total time spent per week in any activity will be determined.
measure: Change in the mean self-reported time per week spent in moderate- to vigorous-intensity physical activity on the Community Health Activities Model Program for Seniors (CHAMPS) Questionnaire
time frame: baseline, 3, 5.5, 12 months
description: The Community Health Activities Model Program for Seniors (CHAMPS) questionnaire is a measure of participation, physical activity and outdoor walking. Participants self-report time spent performing various social, leisure, and physical activities in a typical week during the last 4 weeks. Total time spent per week in moderate- to vigorous-intensity aerobic physical activity is determined.
measure: Change in the mean time per week spent in moderate- to vigorous-intensity physical activity directly measured using ActiGraph and GPS devices
time frame: baseline, 3, 5.5, 12 months
description: The ActiGraph GT3X+ activity monitor (www.actigraphcorp.com/products/wgt3x-monitor/, ActiGraph, Pensacola, FL) and Qstarz BT-Q1000XT A-GPS Travel Recorder (http://www.qstarz.com/Products/GPS%20Products/BT-Q1000XT-F.htm) will be worn by each participant, clipped onto their waist band over the right hip during waking hours for 8 consecutive days at each evaluation timepoint (baseline, 3, 5.5, and 12 months).
measure: Change in the mean score on the Life Space Assessment Questionnaire
time frame: baseline, 3, 5.5, 12 months
description: The Life Space Assessment Questionnaire is a measure of life space mobility. Total scores can range from 0 (totally bed bound) to 120 (travels out of the city every day without assistance). The score indicates level, degree of independence and frequency of attainment of mobility in five living spaces in the past four weeks: rooms in the house, the area outside the house, places in the neighbourhood, places outside the neighbourhood but within the city, and places outside the city.
measure: Change in the mean scores on the Patient Generated Index (PGI)
time frame: baseline, 3, 5.5, 12 months
description: For the PGI, participants select five most important areas of their life that are affected by their health, then rates the degree to which each area is affected from 0 (worst level imaginable) to 10 (best level of function possible).
measure: Change in the mean scores on the Research ANd Development-36 (RAND-36)
time frame: baseline, 3, 5.5, 12 months
description: The RAND-36 is a 36-item self-report measure of 8 health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain and general health perceptions. Total scores range from 0 to 100, where higher scores represent the most optimal health state.
measure: Change in the mean total score on the Mini Balance Evaluations Systems Test (Mini BESTest)
time frame: baseline, 3, 5.5, 12 months
description: The Mini BESTest is a measure of balance. Total scores can range from 0 to 28 points.
measure: Change in the mean number of sit-to-stands completed in 30 seconds in the 30-second Sit to Stand Test.
time frame: baseline, 3, 5.5, 12 months
description: The 30-second Sit to Stand Test is a measure of lower extremity strength. The minimum score is 0.
measure: Change in the mean score on the Ambulatory Self-Confidence Questionnaire
time frame: baseline, 3, 5.5, 12 months
description: The Ambulatory Self-Confidence Questionnaire is a 22-item questionnaire to measure self-efficacy to walk at home and/or in the community. The total score is the mean of item-level scores and can range from 0 to 10.
measure: Change in the mean walking speed on the 10m Walk Test, completed at a comfortable pace and a fast pace
time frame: baseline, 3, 5.5, 12 months
description: The 10m Walk Test is a measure of the participant's walking speed at a comfortable and fast pace. The participant uses his/her usual assistive device(s) and corrective eyewear.
measure: Change in the mean distance (in metres) walked on the 6-Minute Walk Test
time frame: baseline, 3, 5.5, 12 months
description: The 6-Minute Walk Test is a measure of walking endurance. Participants walk for 6 minutes unassisted using his/her usual mobility device. The distance walked in metres in 6 minutes is recorded.
measure: Change in resting heart rate
time frame: baseline, 3, 5.5, 12 months
description: Heart rate (HR) is taken at rest after sitting for at least 5 minutes with back supported and feet flat on the floor. HR is taken through manual palpation of the radial artery for 1 minute. Resting HR is part of the screening for participants prior to administering the 6-Minute Walk Test.
measure: Change in resting blood pressure
time frame: baseline, 3, 5.5, 12 months
description: Blood pressure (BP) is taken at rest after sitting for at least 5 minutes with back supported and feet flat on the floor. BP is taken using a manual or automated documented. Resting BP is part of the screening for participants prior to administering the 6-Minute Walk Test.
arm group label: GO-OUT Group
arm group type: Experimental
description: Participants attend 1-day walking workshop followed by a 3-month outdoor walking group intervention, twice weekly for 60-minutes. The same activities are completed during both sessions within the same week. Each session includes a 10-minute warm-up, a distance walk, practice of a specific outdoor walking skill, a distance walk, and a 10-minute cool down. The warm up and cool down include stretching, functional strengthening exercises and balance exercises taught during the workshop. The program incorporates the principles of task-specific training by emphasizing repetitive practice of progressively more difficult outdoor walking tasks. The outdoor walking program is conducted in one or more large park settings given the mental health benefits of exercising in a natural environment.
arm group label: Workshop Group
arm group type: Active Comparator
description: The 1-day workshop will be 5 hours with breaks. Participants will complete a series of stations learning information, strategies and skills related to safely walking outdoors. Stations include: pedometer use; walking pole use; footwear; footcare; fall prevention; balance exercises; proper use of walking aids; correct posture; self-management of exercise intensity; goal setting; and walking safely outdoors. Participants will receive a workbook with Canadian Physical Activity Guidelines, benefits of outdoor walking, information for each workshop station and a pedometer. Participants will use the workbook as an information resource and to record their community ambulation goals, planning routes, and walking time. All participants will be encouraged to walk outside with a partner, for safety.
intervention type: Other
intervention name: GO-OUT Group
description: Following a baseline assessment, eligible participants will be stratified by site, and randomly assigned to receive the 1-day educational workshop and 3-month outdoor mobility program (GO-OUT intervention). Follow-up evaluations will occur at 3, 5.5 and 12 months from baseline.
arm group label: GO-OUT Group
intervention type: Other
intervention name: Workshop Group
description: the 1-day workshop plus reminders. Follow-up evaluations will occur at 3, 5.5 and 12 months from baseline
arm group label: Workshop Group
criteria: 
gender: All
minimum age: 65 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nancy Salbach, PhD
role: Principal Investigator
affiliation: Associate Professor
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: Dr. Nancy Salbach
investigator title: Professor
sharing ipd: No