Effects of Exercise and Virtual Reality on Depression

Sponsor

The University of Texas at Arlington (Other)

Overall Status

Recruiting

CT.gov ID

NCT05973461

Collaborator

(none)

100

Enrollment

Location

Arms

27.5

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Symptoms of Depression	Device: Exercise and virtual reality Other: Riding a cycle ergometer	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

males and females, with and without symptoms of depressionmales and females, with and without symptoms of depression

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

May 17, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cycle Ergometer and Virtual Reality 30 min ride on cycle ergometer while viewing neighborhood scenes using virtual reality	Device: Exercise and virtual reality Riding a cycle ergometer while experiencing virtual reality
Experimental: Cycle Ergometer 30 min ride on cycle ergometer	Other: Riding a cycle ergometer Riding on a cycle ergometer without experiencing virtual reality

Arm

Intervention/Treatment

Experimental: Cycle Ergometer and Virtual Reality

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

Device: Exercise and virtual reality

Riding a cycle ergometer while experiencing virtual reality

Experimental: Cycle Ergometer

30 min ride on cycle ergometer

Other: Riding a cycle ergometer

Riding on a cycle ergometer without experiencing virtual reality

Outcome Measures

Primary Outcome Measures

Beck Depression Inventory Scale of Measurement [5 minutes]
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) [8 minutes]
A measure of the key aspects of working memory and storage of information over short periods of time.
Neuropsychological Outcomes: Motor Screen Tasks (MOT) [3 minutes]
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 [10 minutes]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UTArlington	Arlington	Texas	United States	76019

Sponsors and Collaborators

The University of Texas at Arlington

Investigators

Principal Investigator: Judy R Wilson, Ph.D., UTArlington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Judy Wilson, Associate Professor, The University of Texas at Arlington

ClinicalTrials.gov Identifier:

NCT05973461

Other Study ID Numbers:

2020-0376

First Posted:

Aug 2, 2023

Last Update Posted:

Aug 2, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Depression

Depressive Disorder

Study Results

No Results Posted as of Aug 2, 2023