xml: <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/NCT05975476</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-300010981</org_study_id>
      <nct_id>NCT05975476</nct_id>
    </id_info>
    <brief_title>Comparison of Two Park-Based Activities on Emotional Well-Being in Adults With Mobility Impairments</brief_title>
    <official_title>Comparison of Two Park-Based Activities to Improve Emotional Well-Being and Reduce Stress of Adults With Mobility Impairments</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Alabama at Birmingham</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Alabama at Birmingham</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>
        This study will examine the impact of a 10-week crossover urban park intervention on the&#xD;
        emotional well-being of people with mobility impairments. Outcomes between 5 weeks of sensory&#xD;
        engagement activity (i.e., enjoy sights, sounds; primarily sedentary) and 5 weeks of physical&#xD;
        activity (i.e., wheeling/walking on trail) while in the park will be compared.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Urban parks promote various forms of recreational activity and are recognized as an effective&#xD;
        means to promote both physical and mental health. People with impaired mobility, however, are&#xD;
        severely underrepresented in available studies on urban parks, Given the high incidence of&#xD;
        secondary conditions (e.g., depression, anxiety, obesity) experienced by adults with&#xD;
        disabilities, this study aims to use green space activities to promote better health. This&#xD;
        study will examine the impact of a 10-week crossover urban park intervention on the emotional&#xD;
        well-being of people with mobility impairments, and compare outcomes between 5 weeks of&#xD;
        sensory engagement activity (i.e., enjoy sights, sounds; primarily sedentary) and 5 weeks of&#xD;
        physical activity (i.e., wheeling/walking on trail) while in the park.&#xD;
  &#xD;
        This project addresses the disparities in mental health and emotional well-being experienced&#xD;
        by individuals with mobility impairments. Findings from this project will serve as a first&#xD;
        step to better understanding the impact of nature-based urban park interventions and will&#xD;
        provide guidance for development of alternative preventive and therapeutic strategies to&#xD;
        promote emotional health for people with mobility impairments. Greater insight into the&#xD;
        mental health benefits of green space exposure among people with mobility impairments is&#xD;
        needed to encourage community and workplace development of local and neighborhood green&#xD;
        spaces with easy access by all.&#xD;
  &#xD;
        Once an individual agrees to participate, meets all study eligibility criteria, and signs the&#xD;
        informed consent, baseline information including demographics, and a hair sample will be&#xD;
        collected. The participant will then scheduled to complete the 10-week park visit program. At&#xD;
        the beginning and end of each phase (physical activity; sensory engagement), the RA will&#xD;
        collect a hair sample (~200 strands) from the participant. For each park visit, participants&#xD;
        will meet a research assistant (RA) at the park entrance. The RA will collect pre-park visit&#xD;
        data which includes having the participant complete two surveys and donate a small amount (~2&#xD;
        ml) of saliva.&#xD;
  &#xD;
        During the first park visit the RA will review park procedures, open an envelope to reveal&#xD;
        the participant's group assignment, and will lead the participant to a designated staging&#xD;
        area inside the park. Each participant will wear a Garmin activity monitor on their wrist,&#xD;
        which will record participant's physical activity-related data. A global positioning system&#xD;
        (GPS) logger will be attached to the participant's wheelchair to track their location in the&#xD;
        park and adherence to the protocol. The RA will record the date and time as the participant&#xD;
        starts the protocol. The RA will be positioned to monitor the participant during the session.&#xD;
  &#xD;
        For participants assigned to the physical activity (PA) group, the RA will provide the&#xD;
        following instructions: Please continuously move at a moderate pace along this trail for 30&#xD;
        minutes, with limited rest periods as needed. At the end of 30 minutes I will meet you here.&#xD;
        Please turn off your cell phone during this time.&#xD;
  &#xD;
        For the sensory engagement activity (SEA) group, the instructions are: Please relax and stay&#xD;
        within this area, enjoy the scenery and engage your senses (see, touch, smell, and listen to&#xD;
        nature around you). You can practice meditation, mindfulness, and daydreaming. At the end of&#xD;
        30 minutes I will meet you here. Please turn off your cell phone during this time.&#xD;
  &#xD;
        The RA will record the time when the participant completes the 30 minute protocol. The&#xD;
        participant will then complete the same surveys used before their park visit, and will&#xD;
        provide a rating of their perceived exertion and level of enjoyment during the session. The&#xD;
        RA will then ask the participant to provide a saliva sample as was done before the park&#xD;
        visit.&#xD;
  &#xD;
        While waiting for the participant to complete the protocol, the RA will use an outdoor&#xD;
        thermometer and hygrometer to record the current weather conditions (temperature and humidity&#xD;
        and sunny, partly sunny, cloudy, or drizzling), and environmental noise levels in the park&#xD;
        activity area.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Crossover Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Emotional Stress - Hair</measure>
      <time_frame>Baseline PA, End of PA Intervention, Baseline SEA, End of SEA Intervention</time_frame>
      <description>A total of about 200 strands of hair will be cut from different parts of the scalp.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Emotional Stress - Saliva</measure>
      <time_frame>Before Each Park Visit, End of Each Park Visit</time_frame>
      <description>Each participant will be instructed to drool ~1.0 ml of saliva into a vial.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Subjective Well-Being (SWLS)</measure>
      <time_frame>Before Each Park Visit, End of Each Park Visit</time_frame>
      <description>Satisfaction with Life Scale, 5 survey questions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective Well-Being (PANAS)</measure>
      <time_frame>Before Each Park Visit, End of Each Park Visit</time_frame>
      <description>Positive Affect and Negative Affect Schedule, 20 survey questions</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Mobility Limitation</condition>
    <condition>Physical Disability</condition>
    <arm_group>
      <arm_group_label>Physical Activity</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Individuals in this group will wheel on a paved trail within the park for 30 minutes 2 times per week for 5 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sensory Engagement</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Individuals in this group will sit comfortably in a peaceful area of the park and enjoy the sights and sounds of nature for 30 minutes 2 times per week for 5 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Physical Activity</intervention_name>
      <description>Participants will be asked to continuously move at a moderate pace along a park trail for 30 minutes, with limited rest periods. The research assistant will monitor the person while in the park and the participant will be asked to turn off their cell phone during this time.</description>
      <arm_group_label>Physical Activity</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Sensory Engagement</intervention_name>
      <description>Participants will be asked to stay within a specific area of the park, relax and enjoy the scenery and engage their senses (see, touch, smell, and listen to nature). In addition, the participant will be told they can engage in meditation, mindfulness, and daydreaming. The research assistant will monitor the person while in the park and the participant will be asked to turn off their cell phone during this time.</description>
      <arm_group_label>Sensory Engagement</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  (1) ages between 18 and 60 years&#xD;
  &#xD;
            -  (2) non-progressive mobility impairment who use a manual wheelchair (e.g., SCI,&#xD;
               transverse myelitis, amputation, spina bifida)&#xD;
  &#xD;
            -  (3) able to propel a manual wheelchair outdoors on even terrain independently&#xD;
  &#xD;
            -  (4) commit to complete the 5-week park visit program in both Fall and Spring seasons.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  (1) bald or not willing to donate a hair sample&#xD;
  &#xD;
            -  (2) weekly park visit to an urban park during the last 3 months&#xD;
  &#xD;
            -  (3) weekly moderate intensity exercise regimen during the last 3 months&#xD;
  &#xD;
            -  (4) having an endocrine disorder (that can affect cortisol levels&#xD;
  &#xD;
            -  (5) taking oral corticosteroids&#xD;
  &#xD;
            -  (6) receiving hormonal therapy&#xD;
  &#xD;
            -  (7) unstable medical condition that prevents outdoor moderate intensity activity&#xD;
  &#xD;
            -  (8) inadequate comprehension and verbal communication in English (i.e., inability to&#xD;
               express basic needs, participate in measurement of outcomes, or provide consent to&#xD;
               participate in the study)&#xD;
  &#xD;
            -  (9) visual impairment that cannot be corrected using assistive devices&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Laurie Malone, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Alabama at Birmingham</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Laurie Malone, PhD</last_name>
      <phone>1-205-934-1876</phone>
      <email>lamalone@uab.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jie Gao, PhD</last_name>
      <phone>1-205-934-7638</phone>
      <email>gaoj@uab.edu</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
      <investigator_full_name>Laurie A Malone, PhD</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mobility Limitation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Given that this is a feasibility study no plans have been made to share the data with other researchers beyond that what is published.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975476
  org study id: IRB-300010981
  nct id: NCT05975476
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will examine the impact of a 10-week crossover urban park intervention on the
        emotional well-being of people with mobility impairments. Outcomes between 5 weeks of sensory
        engagement activity (i.e., enjoy sights, sounds; primarily sedentary) and 5 weeks of physical
        activity (i.e., wheeling/walking on trail) while in the park will be compared.
  Urban parks promote various forms of recreational activity and are recognized as an effective
        means to promote both physical and mental health. People with impaired mobility, however, are
        severely underrepresented in available studies on urban parks, Given the high incidence of
        secondary conditions (e.g., depression, anxiety, obesity) experienced by adults with
        disabilities, this study aims to use green space activities to promote better health. This
        study will examine the impact of a 10-week crossover urban park intervention on the emotional
        well-being of people with mobility impairments, and compare outcomes between 5 weeks of
        sensory engagement activity (i.e., enjoy sights, sounds; primarily sedentary) and 5 weeks of
        physical activity (i.e., wheeling/walking on trail) while in the park.
  
        This project addresses the disparities in mental health and emotional well-being experienced
        by individuals with mobility impairments. Findings from this project will serve as a first
        step to better understanding the impact of nature-based urban park interventions and will
        provide guidance for development of alternative preventive and therapeutic strategies to
        promote emotional health for people with mobility impairments. Greater insight into the
        mental health benefits of green space exposure among people with mobility impairments is
        needed to encourage community and workplace development of local and neighborhood green
        spaces with easy access by all.
  
        Once an individual agrees to participate, meets all study eligibility criteria, and signs the
        informed consent, baseline information including demographics, and a hair sample will be
        collected. The participant will then scheduled to complete the 10-week park visit program. At
        the beginning and end of each phase (physical activity; sensory engagement), the RA will
        collect a hair sample (~200 strands) from the participant. For each park visit, participants
        will meet a research assistant (RA) at the park entrance. The RA will collect pre-park visit
        data which includes having the participant complete two surveys and donate a small amount (~2
        ml) of saliva.
  
        During the first park visit the RA will review park procedures, open an envelope to reveal
        the participant's group assignment, and will lead the participant to a designated staging
        area inside the park. Each participant will wear a Garmin activity monitor on their wrist,
        which will record participant's physical activity-related data. A global positioning system
        (GPS) logger will be attached to the participant's wheelchair to track their location in the
        park and adherence to the protocol. The RA will record the date and time as the participant
        starts the protocol. The RA will be positioned to monitor the participant during the session.
  
        For participants assigned to the physical activity (PA) group, the RA will provide the
        following instructions: Please continuously move at a moderate pace along this trail for 30
        minutes, with limited rest periods as needed. At the end of 30 minutes I will meet you here.
        Please turn off your cell phone during this time.
  
        For the sensory engagement activity (SEA) group, the instructions are: Please relax and stay
        within this area, enjoy the scenery and engage your senses (see, touch, smell, and listen to
        nature around you). You can practice meditation, mindfulness, and daydreaming. At the end of
        30 minutes I will meet you here. Please turn off your cell phone during this time.
  
        The RA will record the time when the participant completes the 30 minute protocol. The
        participant will then complete the same surveys used before their park visit, and will
        provide a rating of their perceived exertion and level of enjoyment during the session. The
        RA will then ask the participant to provide a saliva sample as was done before the park
        visit.
  
        While waiting for the participant to complete the protocol, the RA will use an outdoor
        thermometer and hygrometer to record the current weather conditions (temperature and humidity
        and sunny, partly sunny, cloudy, or drizzling), and environmental noise levels in the park
        activity area.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Emotional Stress - Hair
  time frame: Baseline PA, End of PA Intervention, Baseline SEA, End of SEA Intervention
  description: A total of about 200 strands of hair will be cut from different parts of the scalp.
  measure: Emotional Stress - Saliva
  time frame: Before Each Park Visit, End of Each Park Visit
  description: Each participant will be instructed to drool ~1.0 ml of saliva into a vial.
  measure: Subjective Well-Being (SWLS)
  time frame: Before Each Park Visit, End of Each Park Visit
  description: Satisfaction with Life Scale, 5 survey questions
  measure: Subjective Well-Being (PANAS)
  time frame: Before Each Park Visit, End of Each Park Visit
  description: Positive Affect and Negative Affect Schedule, 20 survey questions
  arm group label: Physical Activity
  arm group type: Experimental
  description: Individuals in this group will wheel on a paved trail within the park for 30 minutes 2 times per week for 5 weeks.
  arm group label: Sensory Engagement
  arm group type: Experimental
  description: Individuals in this group will sit comfortably in a peaceful area of the park and enjoy the sights and sounds of nature for 30 minutes 2 times per week for 5 weeks.
  intervention type: Behavioral
  intervention name: Physical Activity
  description: Participants will be asked to continuously move at a moderate pace along a park trail for 30 minutes, with limited rest periods. The research assistant will monitor the person while in the park and the participant will be asked to turn off their cell phone during this time.
  arm group label: Physical Activity
  intervention type: Behavioral
  intervention name: Sensory Engagement
  description: Participants will be asked to stay within a specific area of the park, relax and enjoy the scenery and engage their senses (see, touch, smell, and listen to nature). In addition, the participant will be told they can engage in meditation, mindfulness, and daydreaming. The research assistant will monitor the person while in the park and the participant will be asked to turn off their cell phone during this time.
  arm group label: Sensory Engagement
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Laurie Malone, PhD
  role: Principal Investigator
  affiliation: The University of Alabama at Birmingham
  last name: Laurie Malone, PhD
  phone: 1-205-934-1876
  email: lamalone@uab.edu
  last name: Jie Gao, PhD
  phone: 1-205-934-7638
  email: gaoj@uab.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Alabama at Birmingham
  investigator full name: Laurie A Malone, PhD
  investigator title: Associate Professor
  mesh term: Mobility Limitation
  sharing ipd: No
  ipd description: Given that this is a feasibility study no plans have been made to share the data with other researchers beyond that what is published.