NCT05985096

Brief Summary

If we examine the demographic data of the 2021 reports of the Turkish Statistical Institute (TUIK), we can see that the young population between the ages of 15 and 24 is 12,971,289 people, which is 15.3% of the total population. Considering the proportion of young population in our country, the evaluation of physical activity level has an important place, while the proportion of female university students who achieved sufficient physical activity level according to the scoring of the International Physical Activity Questionnaire (UFAA) was 8.5%, while the proportion of male students was 28.1% in previous studies (Arslan 2015). ). We know from previous studies that achieving an adequate level of physical activity directly reduces the body mass index and indirectly reduces the cardiovascular risk associated with obesity (Swift 2018). Exercise reduces depression levels and the effects of depression. Although the neural mechanisms are not very clear, there are some predictions for physical exercise to reduce the level of depression (Gujral 2017). The hippocampus is an important cognitive and sensory centre, and it has been reported that hippocampal volume decreases by 5% in depressed individuals (Cole 2011). Hippocampal volume has been reported to increase rapidly with exercise (Bugg 2012). The brain region most affected in major depressive disorder is the prefrontal cortex. After the prefrontal cortex is affected, symptoms such as negative affect and learned helplessness appear (Pizagalli 2021). Experimental studies in mice have shown that treadmill training creates new synaptic pathways in the prefrontal cortex and hippocampus (Mu 2022). Another brain region affected by depression is the corpus striatum. Loss of corpus striatum volume is observed in patients with major depression (Zhang 2020). The volume of the corpus striatum modulates when physical exercise reaches a sufficient level. (Rotttensteiner 2015). Adequate levels of physical activity not only reduce depression, but also prevent neural dysfunction that can occur as a result of depression. However, young people do not get enough exercise. Based on this fact, we believe that it is necessary to use 3D virtual reality applications to increase physical activity levels and exercise motivation. The aim of our study is to investigate the effect of virtual reality training on balance, depression, anxiety and stress parameters in healthy young people.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2024

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 2, 2023

Last Update Submit

August 2, 2023

Conditions

Keywords

DepressionStressAnxietyVirtual reality glasses

Outcome Measures

Primary Outcomes (1)

  • Decrease in depression, anxiety stress parameters

    The specified parameters are calculated using the DASS 21 scale before and after the intervention.

    6 weeks

Secondary Outcomes (1)

  • Increased hand reaction

    6 weeks

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Adequate physical activity not only reduces depression, but also prevents the neural dysfunction that can occur as a result of depression. However, the level of physical activity among young people is not sufficient. Based on this fact, we believe that it is necessary to use 3D virtual reality applications to increase physical activity levels and exercise motivation. The aim of our study is to investigate the effect of virtual reality training on balance, depression, anxiety and stress parameters in healthy young people.

Diagnostic Test: Virtual reality group

Control Group

NO INTERVENTION

The control group will perform individual exercise. The physical activity will be monitored with video recordings.

Interventions

Virtual reality groupDIAGNOSTIC_TEST

Participants in this group will be expected to meet their physical activity levels using the Oculus Quest 2 VR Goggles platform with Racket, Climb, Acron, Skiing, Cycling games.

Virtual Reality Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteering
  • Being between 18-25 years old

You may not qualify if:

  • Having a musculoskeletal disease
  • Having a systemic (cardiovascular, neurological) disease
  • Not attending the training sessions more than once

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University Faculty of Medicine Department of Anatomy

Ordu, Black Sea, 52000, Turkey (Türkiye)

Location

Related Publications (13)

  • Bugg JM, Shah K, Villareal DT, Head D. Cognitive and neural correlates of aerobic fitness in obese older adults. Exp Aging Res. 2012;38(2):131-45. doi: 10.1080/0361073X.2012.659995.

    PMID: 22404537BACKGROUND
  • Cole J, Costafreda SG, McGuffin P, Fu CH. Hippocampal atrophy in first episode depression: a meta-analysis of magnetic resonance imaging studies. J Affect Disord. 2011 Nov;134(1-3):483-7. doi: 10.1016/j.jad.2011.05.057. Epub 2011 Jul 13.

    PMID: 21745692BACKGROUND
  • Perez-de la Cruz S. Comparison between Three Therapeutic Options for the Treatment of Balance and Gait in Stroke: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jan 7;18(2):426. doi: 10.3390/ijerph18020426.

    PMID: 33430476BACKGROUND
  • Cunningham G, Charbonnier C, Ladermann A, Chague S, Sonnabend DH. Shoulder Motion Analysis During Codman Pendulum Exercises. Arthrosc Sports Med Rehabil. 2020 Jun 26;2(4):e333-e339. doi: 10.1016/j.asmr.2020.04.013. eCollection 2020 Aug.

    PMID: 32875297BACKGROUND
  • Gribble PA, Kelly SE, Refshauge KM, Hiller CE. Interrater reliability of the star excursion balance test. J Athl Train. 2013 Sep-Oct;48(5):621-6. doi: 10.4085/1062-6050-48.3.03. Epub 2013 Mar 19.

    PMID: 24067151BACKGROUND
  • Gujral S, Aizenstein H, Reynolds CF 3rd, Butters MA, Erickson KI. Exercise effects on depression: Possible neural mechanisms. Gen Hosp Psychiatry. 2017 Nov;49:2-10. doi: 10.1016/j.genhosppsych.2017.04.012.

    PMID: 29122145BACKGROUND
  • Kubo K, Ikebukuro T, Yata H. Effects of squat training with different depths on lower limb muscle volumes. Eur J Appl Physiol. 2019 Sep;119(9):1933-1942. doi: 10.1007/s00421-019-04181-y. Epub 2019 Jun 22.

    PMID: 31230110BACKGROUND
  • Mu L, Cai J, Gu B, Yu L, Li C, Liu QS, Zhao L. Treadmill Exercise Prevents Decline in Spatial Learning and Memory in 3xTg-AD Mice through Enhancement of Structural Synaptic Plasticity of the Hippocampus and Prefrontal Cortex. Cells. 2022 Jan 12;11(2):244. doi: 10.3390/cells11020244.

    PMID: 35053360BACKGROUND
  • Pizzagalli DA, Roberts AC. Prefrontal cortex and depression. Neuropsychopharmacology. 2022 Jan;47(1):225-246. doi: 10.1038/s41386-021-01101-7. Epub 2021 Aug 2.

    PMID: 34341498BACKGROUND
  • Rottensteiner M, Leskinen T, Niskanen E, Aaltonen S, Mutikainen S, Wikgren J, Heikkila K, Kovanen V, Kainulainen H, Kaprio J, Tarkka IM, Kujala UM. Physical activity, fitness, glucose homeostasis, and brain morphology in twins. Med Sci Sports Exerc. 2015 Mar;47(3):509-18. doi: 10.1249/MSS.0000000000000437.

    PMID: 25003773BACKGROUND
  • Shaffer SW, Teyhen DS, Lorenson CL, Warren RL, Koreerat CM, Straseske CA, Childs JD. Y-balance test: a reliability study involving multiple raters. Mil Med. 2013 Nov;178(11):1264-70. doi: 10.7205/MILMED-D-13-00222.

    PMID: 24183777BACKGROUND
  • Swift DL, McGee JE, Earnest CP, Carlisle E, Nygard M, Johannsen NM. The Effects of Exercise and Physical Activity on Weight Loss and Maintenance. Prog Cardiovasc Dis. 2018 Jul-Aug;61(2):206-213. doi: 10.1016/j.pcad.2018.07.014. Epub 2018 Jul 9.

    PMID: 30003901BACKGROUND
  • Zhang Y, Yang Y, Zhu L, Zhu Q, Jia Y, Zhang L, Peng Q, Wang J, Liu J, Fan W, Wang J. Volumetric Deficit Within the Fronto-Limbic-Striatal Circuit in First-Episode Drug Naive Patients With Major Depression Disorder. Front Psychiatry. 2021 Jan 20;11:600583. doi: 10.3389/fpsyt.2020.600583. eCollection 2020.

    PMID: 33551870BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 14, 2023

Study Start

September 15, 2023

Primary Completion

March 15, 2024

Study Completion

June 5, 2024

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

Locations