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Effects of Exercise and Virtual Reality on Depression

Primary Purpose

Symptoms of Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise and virtual reality
Riding a cycle ergometer
Sponsored by
The University of Texas at Arlington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Symptoms of Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Males and females over the age of 18 years With or without symptoms of depression Physically inactive or sedentary (less than 30 minutes per day) Normal vision and no color blindness No physical disorders such as walking with assistance Exclusion Criteria: Below the age of 18 years or over 65 years, Women who are pregnant Individuals who have been diagnosed with mental disorders Individuals with leg injuries Individuals with cardiac problems Individuals with a history of asthma Individuals with a body mass index over 30.

Sites / Locations

  • UTArlingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cycle Ergometer and Virtual Reality

Cycle Ergometer

Arm Description

30 min ride on cycle ergometer while viewing neighborhood scenes using virtual reality

30 min ride on cycle ergometer

Outcomes

Primary Outcome Measures

Beck Depression Inventory Scale of Measurement
Assessment of symptoms of depression pre and post-intervention cycle exercise. The Beck Depression Inventory is a 21-item, multiple-choice, self-report survey that measures characteristic attitudes and symptoms of depression. The score range is 0-63. The higher the score the more severe the depression. Scores above 41 are considered "extreme depression."
Spatial Working Memory (SWM)
A measure of the key aspects of working memory and storage of information over short periods of time.
Neuropsychological Outcomes: Motor Screen Tasks (MOT)
MOT provides a general indication that psychomotor function is intact enough to proceed with more sophisticated cognitive testing:

Secondary Outcome Measures

Neuropsychological Outcomes: MOT Mean Latency, MOT Total Correct, and MOT Total Errors
This test is a general assessment of whether there are sensorimotor deficits or lack of comprehension. Outcome is measured by reaction time in milliseconds of the participant reaching out and touching the "X" correctly (in the middle of the X) on the tablet in response to the stimulus. The maximum score is 6000 milliseconds. The number of total correct touches and total errors in not touching correctly out of 10 are recorded. Ex: MOT mean latency = 927.9 ml +/- 131.43 ms; MOT Total Correct = 10; MOT Total Errors = 0.

Full Information

First Posted
May 11, 2023
Last Updated
July 31, 2023
Sponsor
The University of Texas at Arlington
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1. Study Identification

Unique Protocol Identification Number
NCT05973461
Brief Title
Effects of Exercise and Virtual Reality on Depression
Official Title
Effects of Exercise With Virtual Reality on Females and Males With or Without Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas at Arlington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is evaluating the effects of riding on a cycle ergometer while experiencing virtual reality to determine its effect on mood.
Detailed Description
Adults (males and females) above the age of 18 yrs will be recruited to determine if they have symptoms of depression based on a questionnaire (Center for Epidemiologic Studies - Depression Scale (CES-D). They will then complete a Beck Inventory before and after the exercise. Participants will be divided into groups either having symptoms of depression or not. They will be randomized to ride on a cycle ergometer with or without using Virtual Reality (VR) that will allow them to view neighborhoods or parks during the exercise. The ergometer will be set at resistance raising the heart rate to 65% of their age-predicted heart rate maximum. They will ride for 20 min and then complete the Beck Inventory to determine any changes in their depressive symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptoms of Depression

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
males and females, with and without symptoms of depression
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cycle Ergometer and Virtual Reality
Arm Type
Experimental
Arm Description
30 min ride on cycle ergometer while viewing neighborhood scenes using virtual reality
Arm Title
Cycle Ergometer
Arm Type
Experimental
Arm Description
30 min ride on cycle ergometer
Intervention Type
Device
Intervention Name(s)
Exercise and virtual reality
Intervention Description
Riding a cycle ergometer while experiencing virtual reality
Intervention Type
Other
Intervention Name(s)
Riding a cycle ergometer
Intervention Description
Riding on a cycle ergometer without experiencing virtual reality
Primary Outcome Measure Information:
Title
Beck Depression Inventory Scale of Measurement
Description
Assessment of symptoms of depression pre and post-intervention cycle exercise. The Beck Depression Inventory is a 21-item, multiple-choice, self-report survey that measures characteristic attitudes and symptoms of depression. The score range is 0-63. The higher the score the more severe the depression. Scores above 41 are considered "extreme depression."
Time Frame
5 minutes
Title
Spatial Working Memory (SWM)
Description
A measure of the key aspects of working memory and storage of information over short periods of time.
Time Frame
8 minutes
Title
Neuropsychological Outcomes: Motor Screen Tasks (MOT)
Description
MOT provides a general indication that psychomotor function is intact enough to proceed with more sophisticated cognitive testing:
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
Neuropsychological Outcomes: MOT Mean Latency, MOT Total Correct, and MOT Total Errors
Description
This test is a general assessment of whether there are sensorimotor deficits or lack of comprehension. Outcome is measured by reaction time in milliseconds of the participant reaching out and touching the "X" correctly (in the middle of the X) on the tablet in response to the stimulus. The maximum score is 6000 milliseconds. The number of total correct touches and total errors in not touching correctly out of 10 are recorded. Ex: MOT mean latency = 927.9 ml +/- 131.43 ms; MOT Total Correct = 10; MOT Total Errors = 0.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females over the age of 18 years With or without symptoms of depression Physically inactive or sedentary (less than 30 minutes per day) Normal vision and no color blindness No physical disorders such as walking with assistance Exclusion Criteria: Below the age of 18 years or over 65 years, Women who are pregnant Individuals who have been diagnosed with mental disorders Individuals with leg injuries Individuals with cardiac problems Individuals with a history of asthma Individuals with a body mass index over 30.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judy R Wilson, PH.D.
Phone
817-272-3128
Email
jrwilson@exchange.uta.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangli Gu, Ph.D.
Email
xiangli.gu@uta.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy R Wilson, Ph.D.
Organizational Affiliation
UTArlington
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTArlington
City
Arlington
State/Province
Texas
ZIP/Postal Code
76019
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judy R Wilson, Ph.D.
Phone
817-272-3128
Email
jrwilson@exchange.uta.edu
First Name & Middle Initial & Last Name & Degree
Xiangli Gu, Ph.D.
Email
xiangli.gu@uta.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Exercise and Virtual Reality on Depression

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