Virtual RealityNCT06464406
Virtual Reality During Exercise Testing
A study testing Virtual Reality condition in people with Virtual Reality, run by Augusta University at 1 site in United States.
Trial summary
The goal of this clinical trial is to explore the effects of virtual reality use on maximal aerobic exercise test performance (aerobic capacity) in healthy adults. The main questions it aims to answer are: Does using a virtual reality program during a maximal aerobic exercise test lead to differences in VO2peak… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- Virtual Reality condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2024to 7 Oct 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- Answering "YES" to one or more items on the Physical Activity Readiness Questionnaire (PAR-Q).
- Women who are pregnant at the time of participation according to a pregnancy test.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30909
Andrew R Moore, PhD, 650-477-7746, andmoore@augusta.edu
About this study
Official title: Effects of Virtual Reality on Cardiorespiratory Fitness Test Results
The goal of this clinical trial is to explore the effects of virtual reality use on maximal aerobic exercise test performance (aerobic capacity) in healthy adults. The main questions it aims to answer are:
- Does using a virtual reality program during a maximal aerobic exercise test lead to differences in VO2peak (maximal aerobic capacity)? and,
- Does using a virtual reality program during a maximal aerobic exercise test lead to differences in work rate at the ventilatory threshold?
Read more
Participants will complete a maximal aerobic exercise test two times (separated by 1 week of recovery) under the following conditions:
- normal testing conditions in a lab
- while viewing a virtual reality video
Researchers will compare the test results of both conditions to see if the use of a virtual reality program alters VO2peak or the ventilatory threshold.
Read the detailed description
Virtual reality imparts a dissociative effect on users during exercise, such that the physical activity task is experienced as more enjoyable and pleasant, requires less exertion, and requires less physiological function for a given submaximal work rate.
This array of positive effects may be particularly advantageous during a maximal aerobic exercise test, mainly because participant motivation and negative psychological state often lead to premature test termination. Ameliorating the unpleasantness of this type of exercise test with the use of virtual reality technology may prolong effort expenditure during the test and result in superior performance compared to a control condition.
Additionally, improving physiological function at submaximal work rates may lead to alterations in other important testing outcomes, particularly the ventilatory threshold. The ventilatory threshold is used as a reference point for prescribing exercise intensity. An intervention that modifies this value would have repercussions for physical fitness practitioners who prescribe exercise intensity relative to the ventilatory threshold.
The general purpose of this study is to determine the effect of virtual reality on maximal aerobic exercise test performance in healthy adults. The specific questions it aims to answer are:
- Does using a virtual reality program during a maximal aerobic exercise test lead to differences in VO2peak (maximal aerobic capacity)? and,
- Does using a virtual reality program during a maximal aerobic exercise test lead to differences in work rate at the ventilatory threshold?
Secondary questions this study aims to answer include:
Does using a virtual reality program during a maximal aerobic exercise test lead to differences in
- exercise test time?
- maximal heart rate during the exercise test?
- maximal respiratory exchange ratio (RER) during the exercise test?
- heart rate (HR) at the ventilatory threshold?
- RER at the ventilatory threshold?
- psychological response [rating of perceived exertion (RPE) and affective valence] throughout the exercise test?
To address these aims, participants will complete the same maximal aerobic exercise test on a cycler ergometer under normal laboratory conditions (Control) and when viewing an immersive virtual reality video (VR). The two tests will be completed in a randomized and counterbalanced order to account for learning or familiarity effects, and will be separated by 1 week to account for the effects of testing fatigue.
Respiratory data, HR, RPE, and affective valence were collected during the exercise tests to address the aims of the study.
- Conditions
- Virtual Reality
- Being tested
- Virtual Reality condition, Control condition
- Keywords
- virtual reality, cardiorespiratory fitness, anaerobic threshold, bicycle ergometer test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality conditionBehavioural
Participants will watch a video on a virtual reality headset during the completion of the maximal cardiorespiratory exercise test.
Control conditionBehavioural
Participants will complete the maximal cardiorespiratory exercise test under control conditions without video, music, or other distractions.
| Study group | Role | What they receive |
|---|---|---|
| Control condition completed first | Experimental | In this arm, the Control condition (traditional maximal cardiorespiratory exercise test) will be completed first, and the Virtual Reality condition (traditional maximal cardiorespiratory exercise test with the addition of virtual reality video) will be completed second. Receives: Behavioral: Virtual Reality condition; Behavioral: Control condition |
| Virtual Reality condition completed first | Experimental | In this arm, the Virtual Reality condition (traditional maximal cardiorespiratory exercise test with the addition of virtual reality video) will be completed first, and the Control condition (traditional maximal cardiorespiratory exercise test) will be completed second. Receives: Behavioral: Virtual Reality condition; Behavioral: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2peak
The highest level of oxygen uptake averaged over a 20-second period.
Measured: Assessed during the exercise test for each condition.
Ventilatory threshold
The work load (in Watts) during the maximal cardiorespiratory exercise test at which breakpoints are identified between metabolic measures associated with the ventilatory threshold (CO2 production and O2 utilization; ventilatory equivalent for O2 and O2 utilization; and excess CO2 production).
Measured: Assessed during the exercise test for each condition.
Secondary outcomes (9)
Peak power
The work load (in Watts) of the highest exercise test stage that was completed
Measured: Assessed during the exercise test for each condition.
Total test time
The duration of the test (in minutes), not including the warm-up.
Measured: Assessed during the exercise test for each condition.
RPE
Rating of Perceived Exertion measured from 0 (no perceived exertion) to 10 (maximal perceived exertion).
Measured: Assessed throughout the exercise test for each condition (at the end of the warm-up and end of every even-numbered stage)..
Affective Valence
Affective valence measured from -5 (feeling very bad) to +5 (feeling very good).
Measured: Assessed throughout the exercise test for each condition (at the end of the warm-up and end of every even-numbered stage)..
%VO2peak at ventilatory threshold
The percentage of VO2peak at which the ventilatory threshold was reached.
Measured: Assessed during the exercise test for each condition.
Heart rate at ventilatory threshold
The heart rate corresponding to the time that the ventilatory threshold was reached.
Measured: Assessed during the exercise test for each condition.
Heart rate at VO2peak
The heart rate (in beats per minute) at which VO2peak was reached.
Measured: Assessed during the exercise test for each condition.
Respiratory Exchange Ratio (RER) at VO2peak
The proportion of carbon dioxide production to oxygen consumption when VO2peak was reached.
Measured: Assessed during the exercise test for each condition.
Respiratory Exchange Ratio (RER) at ventilatory threshold
The proportion of carbon dioxide production to oxygen consumption when the ventilatory threshold was reached.
Measured: Assessed during the exercise test for each condition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start7 Jun 2024
- Primary completion7 Oct 2024 (estimated)
- Study completion7 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will use a repeated-measures crossover model in which each participant completes the two conditions of the maximal exercise test (Control and Virtual Reality) in a randomized, counterbalanced order.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Moore, Augusta University
- Investigators
- Andrew R Moore, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464406
- Sponsor's protocol ID
- 2130870
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality on Cardiorespiratory Fitness Test Results
- ClinicalTrials.gov ID
- NCT06464406
- Acronym / sponsor ID
- 2130870
- Conditions
- Virtual Reality
- Keywords
- virtual reality, cardiorespiratory fitness, anaerobic threshold, bicycle ergometer test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 7 Oct 2024 (estimated)
- Study completion
- 7 Oct 2024 (estimated)
- First posted
- 18 Jun 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.
The goal of this clinical trial is to explore the effects of virtual reality use on maximal aerobic exercise test performance (aerobic capacity) in healthy adults. The main questions it aims to answer are:
- Does using a virtual reality program during a maximal aerobic exercise test lead to differences in VO2peak (maximal aerobic capacity)? and,
- Does using a virtual reality program during a maximal aerobic exercise test lead to differences in work rate at the ventilatory threshold?
Participants will complete a maximal aerobic exercise test two times (separated by 1 week of recovery) under the following conditions:
- normal testing conditions in a lab
- while viewing a virtual reality video
Researchers will compare the test results of both conditions to see if the use of a virtual reality program alters VO2peak or the ventilatory threshold.
Detailed description
Virtual reality imparts a dissociative effect on users during exercise, such that the physical activity task is experienced as more enjoyable and pleasant, requires less exertion, and requires less physiological function for a given submaximal work rate.
This array of positive effects may be particularly advantageous during a maximal aerobic exercise test, mainly because participant motivation and negative psychological state often lead to premature test termination. Ameliorating the unpleasantness of this type of exercise test with the use of virtual reality technology may prolong effort expenditure during the test and result in superior performance compared to a control condition.
Additionally, improving physiological function at submaximal work rates may lead to alterations in other important testing outcomes, particularly the ventilatory threshold. The ventilatory threshold is used as a reference point for prescribing exercise intensity. An intervention that modifies this value would have repercussions for physical fitness practitioners who prescribe exercise intensity relative to the ventilatory threshold.
The general purpose of this study is to determine the effect of virtual reality on maximal aerobic exercise test performance in healthy adults. The specific questions it aims to answer are:
- Does using a virtual reality program during a maximal aerobic exercise test lead to differences in VO2peak (maximal aerobic capacity)? and,
- Does using a virtual reality program during a maximal aerobic exercise test lead to differences in work rate at the ventilatory threshold?
Secondary questions this study aims to answer include:
Does using a virtual reality program during a maximal aerobic exercise test lead to differences in
- exercise test time?
- maximal heart rate during the exercise test?
- maximal respiratory exchange ratio (RER) during the exercise test?
- heart rate (HR) at the ventilatory threshold?
- RER at the ventilatory threshold?
- psychological response [rating of perceived exertion (RPE) and affective valence] throughout the exercise test?
To address these aims, participants will complete the same maximal aerobic exercise test on a cycler ergometer under normal laboratory conditions (Control) and when viewing an immersive virtual reality video (VR). The two tests will be completed in a randomized and counterbalanced order to account for learning or familiarity effects, and will be separated by 1 week to account for the effects of testing fatigue.
Respiratory data, HR, RPE, and affective valence were collected during the exercise tests to address the aims of the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will use a repeated-measures crossover model in which each participant completes the two conditions of the maximal exercise test (Control and Virtual Reality) in a randomized, counterbalanced order.
| Arm | Type | Receives |
|---|---|---|
| Control condition completed first | Experimental | Behavioral: Virtual Reality condition, Behavioral: Control conditionIn this arm, the Control condition (traditional maximal cardiorespiratory exercise test) will be completed first, and the Virtual Reality condition (traditional maximal cardiorespiratory exercise test with the addition of virtual reality video) will be completed second. |
| Virtual Reality condition completed first | Experimental | Behavioral: Virtual Reality condition, Behavioral: Control conditionIn this arm, the Virtual Reality condition (traditional maximal cardiorespiratory exercise test with the addition of virtual reality video) will be completed first, and the Control condition (traditional maximal cardiorespiratory exercise test) will be completed second. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (2 listed)
- Answering "YES" to one or more items on the Physical Activity Readiness Questionnaire (PAR-Q).
- Women who are pregnant at the time of participation according to a pregnancy test.
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 |
|---|---|---|
| Virtual Reality conditionParticipants will watch a video on a virtual reality headset during the completion of the maximal cardiorespiratory exercise test. | Behavioural | Control condition completed first, Virtual Reality condition completed first |
| Control conditionParticipants will complete the maximal cardiorespiratory exercise test under control conditions without video, music, or other distractions. | Behavioural | Control condition completed first, Virtual Reality condition completed first |
Primary outcome
VO2peak
Time frame: Assessed during the exercise test for each condition.
The highest level of oxygen uptake averaged over a 20-second period.
Ventilatory threshold
Time frame: Assessed during the exercise test for each condition.
The work load (in Watts) during the maximal cardiorespiratory exercise test at which breakpoints are identified between metabolic measures associated with the ventilatory threshold (CO2 production and O2 utilization; ventilatory equivalent for O2 and O2 utilization; and excess CO2 production).
9 secondary outcomes
Peak power
Time frame: Assessed during the exercise test for each condition.
Total test time
Time frame: Assessed during the exercise test for each condition.
RPE
Time frame: Assessed throughout the exercise test for each condition (at the end of the warm-up and end of every even-numbered stage)..
Affective Valence
Time frame: Assessed throughout the exercise test for each condition (at the end of the warm-up and end of every even-numbered stage)..
%VO2peak at ventilatory threshold
Time frame: Assessed during the exercise test for each condition.
Heart rate at ventilatory threshold
Time frame: Assessed during the exercise test for each condition.
Heart rate at VO2peak
Time frame: Assessed during the exercise test for each condition.
Respiratory Exchange Ratio (RER) at VO2peak
Time frame: Assessed during the exercise test for each condition.
Respiratory Exchange Ratio (RER) at ventilatory threshold
Time frame: Assessed during the exercise test for each condition.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- 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.
Andrew R Moore, PhD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality condition in people with Virtual Reality, run by Augusta University at 1 site in United States.
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 1 inclusion and 2 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 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Andrew R Moore, PhD (650-477-7746, andmoore@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2peak (time frame: Assessed during the exercise test for each condition.). 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?
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 21 Jun 2024.