What side effects are associated with this type of intervention?

Physical exercise as a treatment for depression is generally well-tolerated with minimal side effects, though some individuals may experience muscle soreness, fatigue, or injury if not performed correctly. Virtual reality-based therapies are relatively new, but potential side effects may include motion sickness, dizziness, and eye strain. Overall, these treatments are considered to have fewer and less severe side effects compared to pharmacologic treatments such as antidepressants, which can include nausea, weight gain, sexual dysfunction, and insomnia.

What prior FDA approvals exist?

The FDA has approved several treatments for depression, primarily focusing on pharmacotherapy and psychotherapy. While traditional treatments include antidepressants like SSRIs and SNRIs, there is growing interest in non-pharmacological approaches such as physical exercise. Although specific FDA approvals for treatments combining physical exercise with immersive experiences like virtual reality are not mentioned, exercise itself has shown moderate clinical benefits for depression. This suggests potential for innovative treatments like the Cycle Ergometer with Virtual Reality being studied, which combines physical activity with enhanced immersive experiences to improve mood.

What other types of research exist?

Promising alternatives to Cycle Ergometer with Virtual Reality for treating depression include: 1) Active video games (exergaming) using motion-sensing controllers, which combine physical activity with engaging gameplay. 2) Compulsive Exercise Activity Therapy (LEAP), which addresses compulsive exercise behaviors in a structured manner. 3) Mixed exercise training programs that incorporate various forms of physical activity tailored to individual preferences and capabilities.

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Exercise with Virtual Reality for Depression

N/A

Recruiting

Led By Judy R Wilson, Ph.D.

Research Sponsored by The University of Texas at Arlington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if riding a stationary bike while watching virtual reality scenes can improve mood in adults over 18, especially those with depressive symptoms. The exercise raises heart rate and releases endorphins, while VR makes it more enjoyable.

Who is the study for?

This trial is for men and women over 18 who are mostly inactive, have normal vision without color blindness, and may or may not be experiencing symptoms of depression. It's not suitable for those under 18 or over 65, pregnant women, individuals with asthma, leg injuries, mental disorders other than depression, cardiac issues, or a BMI over 30.

What is being tested?

The study is testing the impact of exercise combined with virtual reality on mood. Participants will ride a cycle ergometer—a stationary exercise bike—while immersed in a virtual environment to see if it affects their depression.

What are the potential side effects?

Since this intervention involves physical activity and virtual reality exposure, potential side effects might include motion sickness from VR use and typical exercise-related discomforts such as muscle soreness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Beck Depression Inventory Scale of Measurement

Neuropsychological Outcomes: Motor Screen Tasks (MOT)

Spatial Working Memory (SWM)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cycle Ergometer and Virtual RealityExperimental Treatment1 Intervention

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

Group II: Cycle ErgometerExperimental Treatment1 Intervention

30 min ride on cycle ergometer

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise and virtual reality

2022

N/A

~100

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression, such as physical exercise and virtual reality (VR) therapies, work through several mechanisms. Physical exercise boosts mood by increasing endorphins and neurotransmitters like serotonin and dopamine, which are often low in depression. It also reduces inflammation and promotes neurogenesis, enhancing brain function and resilience. VR therapies offer immersive experiences that distract from negative thoughts, reduce anxiety, and create positive, engaging environments. These mechanisms are important for depression patients as they provide non-pharmacological options that can complement traditional treatments, potentially leading to better overall outcomes.

Movement therapy with depressed inpatients: a randomized multiple single case design.Efficacy and acceptability of different interventions for acrophobia: A network meta-analysis of randomised controlled trials.Using virtual reality to target positive autobiographical memory in individuals with moderate-to-moderately severe depressive symptoms: A single case experimental design.