Effects of Exercise and Virtual Reality on Depression

Symptoms of Depression Clinical Trial

Official title:

Effects of Exercise With Virtual Reality on Females and Males With or Without Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05973461
• Other study ID #: 2020-0376
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: June 14, 2025

Study information

• Verified date: April 2024
• Source: The University of Texas at Arlington
• Contact: Judy R Wilson, PH.D.
• Phone: 817-272-3128
• Email: jrwilson[@]exchange.uta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is evaluating the effects of riding on a cycle ergometer while experiencing virtual reality to determine its effect on mood.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 14, 2025
• Est. primary completion date: June 14, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Symptoms of Depression

Intervention

Device:
• Exercise and virtual reality
Riding a cycle ergometer while experiencing virtual reality

Other:
• Riding a cycle ergometer
Riding on a cycle ergometer without experiencing virtual reality

Locations

Country	Name	City	State
United States	UTArlington	Arlington	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas at Arlington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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."	5 minutes
Primary	Spatial Working Memory (SWM)	A measure of the key aspects of working memory and storage of information over short periods of time.	8 minutes
Primary	Neuropsychological Outcomes: Motor Screen Tasks (MOT)	MOT provides a general indication that psychomotor function is intact enough to proceed with more sophisticated cognitive testing:	3 minutes
Secondary	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.	10 minutes