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Comparison of Two Park-Based Activities on Emotional Well-Being in Adults With Mobility Impairments

Primary Purpose

Mobility Limitation, Physical Disability

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical Activity
Sensory Engagement
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mobility Limitation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: (1) ages between 18 and 60 years (2) non-progressive mobility impairment who use a manual wheelchair (e.g., SCI, transverse myelitis, amputation, spina bifida) (3) able to propel a manual wheelchair outdoors on even terrain independently (4) commit to complete the 5-week park visit program in both Fall and Spring seasons. Exclusion Criteria: (1) bald or not willing to donate a hair sample (2) weekly park visit to an urban park during the last 3 months (3) weekly moderate intensity exercise regimen during the last 3 months (4) having an endocrine disorder (that can affect cortisol levels (5) taking oral corticosteroids (6) receiving hormonal therapy (7) unstable medical condition that prevents outdoor moderate intensity activity (8) inadequate comprehension and verbal communication in English (i.e., inability to express basic needs, participate in measurement of outcomes, or provide consent to participate in the study) (9) visual impairment that cannot be corrected using assistive devices

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Physical Activity

    Sensory Engagement

    Arm Description

    Individuals in this group will wheel on a paved trail within the park for 30 minutes 2 times per week for 5 weeks.

    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.

    Outcomes

    Primary Outcome Measures

    Emotional Stress - Hair
    A total of about 200 strands of hair will be cut from different parts of the scalp.
    Emotional Stress - Saliva
    Each participant will be instructed to drool ~1.0 ml of saliva into a vial.

    Secondary Outcome Measures

    Subjective Well-Being (SWLS)
    Satisfaction with Life Scale, 5 survey questions
    Subjective Well-Being (PANAS)
    Positive Affect and Negative Affect Schedule, 20 survey questions

    Full Information

    First Posted
    July 27, 2023
    Last Updated
    September 22, 2023
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05975476
    Brief Title
    Comparison of Two Park-Based Activities on Emotional Well-Being in Adults With Mobility Impairments
    Official Title
    Comparison of Two Park-Based Activities to Improve Emotional Well-Being and Reduce Stress of Adults With Mobility Impairments
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    September 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mobility Limitation, Physical Disability

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical Activity
    Arm Type
    Experimental
    Arm 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 Title
    Sensory Engagement
    Arm Type
    Experimental
    Arm 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(s)
    Physical Activity
    Intervention 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Sensory Engagement
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Emotional Stress - Hair
    Description
    A total of about 200 strands of hair will be cut from different parts of the scalp.
    Time Frame
    Baseline PA, End of PA Intervention, Baseline SEA, End of SEA Intervention
    Title
    Emotional Stress - Saliva
    Description
    Each participant will be instructed to drool ~1.0 ml of saliva into a vial.
    Time Frame
    Before Each Park Visit, End of Each Park Visit
    Secondary Outcome Measure Information:
    Title
    Subjective Well-Being (SWLS)
    Description
    Satisfaction with Life Scale, 5 survey questions
    Time Frame
    Before Each Park Visit, End of Each Park Visit
    Title
    Subjective Well-Being (PANAS)
    Description
    Positive Affect and Negative Affect Schedule, 20 survey questions
    Time Frame
    Before Each Park Visit, End of Each Park Visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: (1) ages between 18 and 60 years (2) non-progressive mobility impairment who use a manual wheelchair (e.g., SCI, transverse myelitis, amputation, spina bifida) (3) able to propel a manual wheelchair outdoors on even terrain independently (4) commit to complete the 5-week park visit program in both Fall and Spring seasons. Exclusion Criteria: (1) bald or not willing to donate a hair sample (2) weekly park visit to an urban park during the last 3 months (3) weekly moderate intensity exercise regimen during the last 3 months (4) having an endocrine disorder (that can affect cortisol levels (5) taking oral corticosteroids (6) receiving hormonal therapy (7) unstable medical condition that prevents outdoor moderate intensity activity (8) inadequate comprehension and verbal communication in English (i.e., inability to express basic needs, participate in measurement of outcomes, or provide consent to participate in the study) (9) visual impairment that cannot be corrected using assistive devices
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laurie Malone, PhD
    Phone
    1-205-934-1876
    Email
    lamalone@uab.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jie Gao, PhD
    Phone
    1-205-934-7638
    Email
    gaoj@uab.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laurie Malone, PhD
    Organizational Affiliation
    The University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan 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.

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    Comparison of Two Park-Based Activities on Emotional Well-Being in Adults With Mobility Impairments

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