Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05975476 |
| Other study ID # |
IRB-300010981 |
| Secondary ID |
Internal grant |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2024 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
April 2024 |
| Source |
University of Alabama at Birmingham |
| Contact |
Laurie Malone, PhD |
| Phone |
1-205-934-1876 |
| Email |
lamalone[@]uab.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
