Physical ActivityNCT06580769
Effects of an Immersive Virtual Reality Program
A study testing Physical activity in people with Physical Activity and Virtual Reality, run by Universidad Autónoma de Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Virtual Reality, Physical Fitness
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be a university student
- Present medical consent authorizing the performance of physical activity
- Signing of informed consent
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects on Physical Condition and Body Composition of a Physical Exercise Program Implemented Through Immersive Virtual Reality in University Adults: Protocol for a Randomized Controlled Trial
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.
Read the detailed description
Physical fitness (PF) is a measure that integrates most of the body's functions that are involved during the performance of any physical activity or physical exercise. Although its variation depends largely on genetic components, the physical exercise factor is one of the environmental conditioning factors that most influence its development. Evidence indicates that adequate PF values are considered important for people's health as they are related to better cardiovascular, skeletal, and mental health, which is why PF is considered an important component of a healthy lifestyle.
On the other hand, there is body composition, which is responsible for quantifying, determining relationships and defining the quantitative changes of the different components of the human body. Its study is important to understand the effect of environmental factors such as growth, diet, diseases and physical exercise on the body. Research that has studied the effects of physical activity interventions aimed at improving PF indicates that they lead to improvements in people's body composition, specifically, reductions in fat and increases in muscle mass. This is beneficial for health, since a greater accumulation of fat in regions such as the waist and abdomen increases the risk factor for the development of metabolic diseases and insulin resistance, while adequate muscle mass values are associated with improvements in the metabolism of hepatic, pancreatic, and immune tissue, among others.
Despite ample evidence exposing the health benefits, more than a quarter of adults worldwide are physically inactive. Among the factors that explain this behavior is that the practice of physical exercise is considered boring and difficult, which together with long working hours, keeps people away from the practice, which added to factors such as lack of motivation, family and social support, nearby sports environments and habits of practicing physical activity, generate negative attitudes towards physical activity, which leads to not practicing it. All of the above increases in university students, a complex population, due to the influence of bad healthy habits as a result of the impact of the academic load, the change from school life to university life and all university obligations.
A tool that could be useful to eliminate the barriers described for not practicing physical activity can be immersive virtual reality (IVR), 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 from a simulated world. all through an avatar that allows movements to be shown in a way that is consistent with the subject's body in a first-person perspective, making participants adjust their real actions in response to the observed movements of the avatar, driven by the illusory sensation of having the avatar's body, which generates measurable motor and physiological responses in the real body. In this sense, the RVI allows us to experience situations that, in reality, due to the necessary time or space, would not be possible.
Several studies have analyzed the benefits of IVR in the field of public health, allowing greater effectiveness in the work of repetitive tasks, graphic and acoustic feedback, and adherence to physical therapies. This has been reflected in several studies that describe the effects of programs implemented through IVR in the rehabilitation of patients with cardiovascular accidents, Parkinson's, fibromyalgia and obstructive pulmonary diseases, among others.
Regarding the area of physical exercise, the evidence places it as a tool that encourages healthy behaviors and the practice of physical activity, increasing adherence to exercise in the long term. A recent scoping review established that its use stimulates moderate and vigorous intensity levels, which could contribute to meeting physical activity recommendations, while other studies conclude that practicing physical exercise through IVR causes moderate and vigorous intensity physical activity, which are the ones that bring health benefits. On the other hand, there is information that indicates that performing physical activity through IVR generates a high level of enjoyment in participants, greater calorie burning, greater concentration and the feeling of being able to continue exercising for longer.
Taking into account that the practice of physical exercise in the adult population is low, even more so in the university population, the IVR could be an alternative way to overcome the limitations that prevent the practice of physical exercise in adults. In addition, if the use of this technology generates enjoyment in those who use it and contributes to complying with the recommendations for physical activity, it is logical to think that a physical exercise program executed through IVR could contribute to improving PF and reducing body fat values and increasing muscle mass. However, the available evidence has not found information describing the effects of running exercise programs through IVR on physical fitness, nor the fat and muscle components of body composition. This study will provide useful information for this emerging line of research. It is hypothesized that the physical exercise program carried out through immersive virtual reality will cause improvements in physical condition and body composition in university adults. The objective of this randomized controlled trial is to evaluate the effect on physical fitness and body composition of a physical exercise program performed through immersive virtual reality in university adults.
- Conditions
- Physical Activity, Virtual Reality, Physical Fitness
- Being tested
- Physical activity
- Keywords
- fat, Muscle, strength, cardiorespiratory fitness
- Medical subject headings
- Motor Activity, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
Implementation of a physical activity program, executed through immersive virtual reality
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | They will develop the physics activity program through immersive virtual reality Receives: Other: Physical activity |
| Experimental 2 | Experimental | They will develop a physical activity program through HIIT Receives: Other: Physical activity |
| Control | No intervention | They do not perform physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From registration to the end of the physical activity intervention, it will be a period of 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrés Godoy Cumillaf, Universidad Autónoma de Chile
- Investigators
- Paola Fuentes-Merino, MsC, Principal investigator, Universidad Autónoma de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580769
- Sponsor's protocol ID
- UAChileTco
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37297694Godoy-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.
PubMed 36181063Sousa 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.
PubMed 34004390Debska 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.
PubMed 31574911Godoy-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.
PubMed 41370823
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Physical Condition and Body Composition of a Physical Exercise Program Implemented Through Immersive Virtual Reality in University Adults: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06580769
- Acronym / sponsor ID
- UAChileTco
- Conditions
- Physical Activity, Virtual Reality, Physical Fitness
- Keywords
- fat, Muscle, strength, cardiorespiratory fitness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Autónoma de ChileUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Physical fitness (PF) is a measure that integrates most of the body's functions that are involved during the performance of any physical activity or physical exercise. Although its variation depends largely on genetic components, the physical exercise factor is one of the environmental conditioning factors that most influence its development. Evidence indicates that adequate PF values are considered important for people's health as they are related to better cardiovascular, skeletal, and mental health, which is why PF is considered an important component of a healthy lifestyle.
On the other hand, there is body composition, which is responsible for quantifying, determining relationships and defining the quantitative changes of the different components of the human body. Its study is important to understand the effect of environmental factors such as growth, diet, diseases and physical exercise on the body. Research that has studied the effects of physical activity interventions aimed at improving PF indicates that they lead to improvements in people's body composition, specifically, reductions in fat and increases in muscle mass. This is beneficial for health, since a greater accumulation of fat in regions such as the waist and abdomen increases the risk factor for the development of metabolic diseases and insulin resistance, while adequate muscle mass values are associated with improvements in the metabolism of hepatic, pancreatic, and immune tissue, among others.
Despite ample evidence exposing the health benefits, more than a quarter of adults worldwide are physically inactive. Among the factors that explain this behavior is that the practice of physical exercise is considered boring and difficult, which together with long working hours, keeps people away from the practice, which added to factors such as lack of motivation, family and social support, nearby sports environments and habits of practicing physical activity, generate negative attitudes towards physical activity, which leads to not practicing it. All of the above increases in university students, a complex population, due to the influence of bad healthy habits as a result of the impact of the academic load, the change from school life to university life and all university obligations.
A tool that could be useful to eliminate the barriers described for not practicing physical activity can be immersive virtual reality (IVR), 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 from a simulated world. all through an avatar that allows movements to be shown in a way that is consistent with the subject's body in a first-person perspective, making participants adjust their real actions in response to the observed movements of the avatar, driven by the illusory sensation of having the avatar's body, which generates measurable motor and physiological responses in the real body. In this sense, the RVI allows us to experience situations that, in reality, due to the necessary time or space, would not be possible.
Several studies have analyzed the benefits of IVR in the field of public health, allowing greater effectiveness in the work of repetitive tasks, graphic and acoustic feedback, and adherence to physical therapies. This has been reflected in several studies that describe the effects of programs implemented through IVR in the rehabilitation of patients with cardiovascular accidents, Parkinson's, fibromyalgia and obstructive pulmonary diseases, among others.
Regarding the area of physical exercise, the evidence places it as a tool that encourages healthy behaviors and the practice of physical activity, increasing adherence to exercise in the long term. A recent scoping review established that its use stimulates moderate and vigorous intensity levels, which could contribute to meeting physical activity recommendations, while other studies conclude that practicing physical exercise through IVR causes moderate and vigorous intensity physical activity, which are the ones that bring health benefits. On the other hand, there is information that indicates that performing physical activity through IVR generates a high level of enjoyment in participants, greater calorie burning, greater concentration and the feeling of being able to continue exercising for longer.
Taking into account that the practice of physical exercise in the adult population is low, even more so in the university population, the IVR could be an alternative way to overcome the limitations that prevent the practice of physical exercise in adults. In addition, if the use of this technology generates enjoyment in those who use it and contributes to complying with the recommendations for physical activity, it is logical to think that a physical exercise program executed through IVR could contribute to improving PF and reducing body fat values and increasing muscle mass. However, the available evidence has not found information describing the effects of running exercise programs through IVR on physical fitness, nor the fat and muscle components of body composition. This study will provide useful information for this emerging line of research. It is hypothesized that the physical exercise program carried out through immersive virtual reality will cause improvements in physical condition and body composition in university adults. The objective of this randomized controlled trial is to evaluate the effect on physical fitness and body composition of a physical exercise program performed through immersive virtual reality in university adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Physical activityThey will develop the physics activity program through immersive virtual reality |
| Experimental 2 | Experimental | Other: Physical activityThey will develop a physical activity program through HIIT |
| Control | No intervention | –They do not perform physical activity |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Be a university student
- Present medical consent authorizing the performance of physical activity
- Signing of informed consent
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityImplementation of a physical activity program, executed through immersive virtual reality | Other | Experimental, Experimental 2 |
Primary outcome
Physical fitness
Time frame: From registration to the end of the physical activity intervention, it will be a period of 16 weeks.
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.
Body Composition
Time frame: From registration to the end of the physical activity intervention, it will be a period of 16 weeks.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 37297694Giakoni-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.
- Results publication: PubMed 36181063Godoy-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.
- Results publication: PubMed 34004390Sousa 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.
- Results publication: PubMed 31574911Debska 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.
- Derived from this study: PubMed 41370823Godoy-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola Fuentes-Merino, MsC principal investigator
Universidad Autónoma de Chile
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Physical Activity and Virtual Reality, run by Universidad Autónoma de Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andres Godoy-Cumillaf, PhD (+56953534223, andres.godoy@uautonoma.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical fitness (time frame: From registration to the end of the physical activity intervention, it will be a period of 16 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06580769, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024; AzTrials last refreshed its copy on 29 Oct 2026.