NCT06580769

Brief Summary

A tool that could be useful to eliminate the barriers of not practicing physical activity can be immersive virtual reality, which is characterized by being a technique where a person, through the use of a screen mounted on the head, receives images, sounds and tactile sensations of a simulated world. In the area of physical exercise, evidence places immersive virtual reality as a tool that encourages healthy behaviors and the practice of physical activity, increasing adherence to exercise in the long term. In addition to the fact that performing physical activity by this means generates a high level of enjoyment in the participants, so if the use of this technology generates enjoyment in those who use it and contributes to complying with the recommendations of physical activity, it is logical to think that a physical exercise program executed through immersive virtual reality could contribute to improving parameters related to people's health. Therefore, the objective of this randomized controlled trial is to evaluate the effect of a physical exercise program carried out through immersive virtual reality on health-related variables.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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 21, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

November 19, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 21, 2024

Last Update Submit

November 18, 2024

Conditions

Keywords

fatMusclestrengthcardiorespiratory fitness

Outcome Measures

Primary Outcomes (2)

  • Physical fitness

    Cardiorespiratory fitness will be measured through the 20-meter shuttle run test, and maximum oxygen consumption will be estimated. Lower body muscle strength will be measured through the long jump test. Upper body muscle strength will be measured through manual grip strength (Takei 5401). Speed/agility will be assessed through the 4x10 test.

    From registration to the end of the physical activity intervention, it will be a period of 16 weeks.

  • Body Composition

    Weight will be evaluated through a scale (Seca 222), with the participant barefoot and with the least possible clothing. Size will be obtained with a height gauge (Seca 222), with the participant barefoot, in an upright position, at the end of a normal inspiration. Both measures will be taken in duplicate, using the mean for statistical analyses. Body mass index will be determined by dividing weight by height squared. Waist circumference will be determined at the midpoint between the last rib and the iliac crest. The average of two measurements will be used. The percentage of adipose and muscle tissue will be calculated by means of tetrapolar electrical bioimpedance (Tanita MC 780U). It will be complemented by the measurement of body perimeters, bone diameters and skin folds, according to the protocol described by the International Society for the Advancement of Kineanthropometry.

    From registration to the end of the physical activity intervention, it will be a period of 16 weeks.

Study Arms (3)

Experimental

EXPERIMENTAL

They will develop the physics activity program through immersive virtual reality

Other: Physical activity

Experimental 2

EXPERIMENTAL

They will develop a physical activity program through HIIT

Other: Physical activity

Control

NO INTERVENTION

They do not perform physical activity

Interventions

Implementation of a physical activity program, executed through immersive virtual reality

ExperimentalExperimental 2

Eligibility Criteria

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

You may qualify if:

  • Be a university student
  • Present medical consent authorizing the performance of physical activity
  • Signing of informed consent

You may not qualify if:

  • Have a physical or mental impairment that prevents you from engaging in physical activity
  • Have a vision impairment that does not allow you to use the immersive virtual reality
  • Belong to a special interest group (professional athletes or pregnant women)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Giakoni-Ramirez F, Godoy-Cumillaf A, Espoz-Lazo S, Duclos-Bastias D, Del Val Martin P. Physical Activity in Immersive Virtual Reality: A Scoping Review. Healthcare (Basel). 2023 May 25;11(11):1553. doi: 10.3390/healthcare11111553.

    PMID: 37297694BACKGROUND
  • Godoy-Cumillaf A, Fuentes-Merino P, Giakoni-Ramirez F, Duclos-Bastias D, Merellano-Navarro E. Effectiveness of a physical activity intervention on the overweight and obesity of Chilean schoolchildren. Medicine (Baltimore). 2022 Sep 30;101(39):e30908. doi: 10.1097/MD.0000000000030908.

  • Sousa CV, Hwang J, Cabrera-Perez R, Fernandez A, Misawa A, Newhook K, Lu AS. Active video games in fully immersive virtual reality elicit moderate-to-vigorous physical activity and improve cognitive performance in sedentary college students. J Sport Health Sci. 2022 Mar;11(2):164-171. doi: 10.1016/j.jshs.2021.05.002. Epub 2021 May 16.

  • Debska M, Polechonski J, Mynarski A, Polechonski P. Enjoyment and Intensity of Physical Activity in Immersive Virtual Reality Performed on Innovative Training Devices in Compliance with Recommendations for Health. Int J Environ Res Public Health. 2019 Sep 30;16(19):3673. doi: 10.3390/ijerph16193673.

  • Godoy-Cumillaf A, Fuentes-Merino P, Giakoni-Ramirez F, Munoz-Strale C, de Souza-Lima J, Duclos-Bastias D, Parra-Saldias M, Bruneau-Chavez J, Merellano-Navarro E. Effects of a Walking-Based Physical Activity Intervention on Health Indicators in University Students: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Dec 10;14:e83983. doi: 10.2196/83983.

MeSH Terms

Conditions

Motor ActivityPlatelet Glycoprotein IV Deficiency

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Paola Fuentes-Merino, MsC

    Universidad Autónoma de Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andres Godoy-Cumillaf, PhD

CONTACT

Paola Fuentes-Merino, MsC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2024

First Posted

August 30, 2024

Study Start

December 1, 2024

Primary Completion

March 30, 2025

Study Completion

April 30, 2025

Last Updated

November 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share