Effects of Exercise and Virtual Reality on Depression

NCT05973461 | Recruiting FDA Device

• 1 other identifier: 2020-0376
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Symptoms of Depression

Outcome Measures

Primary Outcomes (3)

• 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

• Spatial Working Memory (SWM)

  A measure of the key aspects of working memory and storage of information over short periods of time.

  8 minutes

• 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 Outcomes (1)

• Neuropsychological Outcomes: MOT Mean Latency, MOT Total Correct, and MOT Total Errors

  10 minutes

Study Arms (2)

Cycle Ergometer and Virtual Reality

EXPERIMENTAL

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

Device: Exercise and virtual reality

Cycle Ergometer

EXPERIMENTAL

30 min ride on cycle ergometer

Other: Riding a cycle ergometer

Interventions

Riding a cycle ergometer OTHER

Riding on a cycle ergometer without experiencing virtual reality

Cycle Ergometer

Exercise and virtual reality DEVICE

Riding a cycle ergometer while experiencing virtual reality

Cycle Ergometer and Virtual Reality

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas at Arlington: lead

Study Sites (1)

UTArlington

Arlington, Texas, 76019, United States

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Judy R Wilson, Ph.D.

  UTArlington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judy R Wilson, PH.D.

CONTACT

817-272-3128; jrwilson@exchange.uta.edu

Xiangli Gu, Ph.D.

CONTACT

xiangli.gu@uta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: males and females, with and without symptoms of depression

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: August 2, 2023
• Study Start: May 17, 2022
• Primary Completion (Estimated): June 14, 2026
• Study Completion (Estimated): June 14, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)