Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06420414 |
Other study ID # |
10853 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2023 |
Est. completion date |
January 31, 2023 |
Study information
Verified date |
May 2024 |
Source |
Teesside University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study aimed to explore the feasibility and effectiveness of immersive Virtual Reality
(VR) as an alternative to traditional High-Intensity Interval Training (HIIT) by comparing
physiological and psychological outcomes in physically active university students. The pilot
randomised controlled trial utilised a parallel design involving two groups: one group
performed HIIT using the Facebook Oculus Quest 2 VR headset with the "FitXR" fitness game,
while the other undertook traditional HIIT training that mirrored the movements and actions
of the VR game.
The study's findings suggest that fully immersive VR provides a unique and potentially more
enjoyable alternative to traditional HIIT, particularly because it may enhance motivation
while still achieving health benefits. This pilot research study highlights VR's potential to
reach high-flow states in exercise, where individuals become deeply absorbed and derive
satisfaction from the activity. It also lays the groundwork for future studies involving
larger sample sizes and clinical populations to further investigate the psychological and
physiological impacts of VR-based exercise.
In summary, this pilot randomised controlled trial found that immersive VR could be a
feasible and effective alternative to traditional HIIT training, offering similar
physiological benefits while enhancing exercise motivation and enjoyment. Further research is
necessary to validate these preliminary results and extend them to diverse populations.
Description:
Study Objectives and Design This study was designed as a pilot randomised controlled trial
(RCT) to investigate the feasibility, efficacy, and effects of immersive VR compared to
traditional HIIT on physiological and psychological outcomes in physically active university
students. The parallel-design trial was conducted in accordance with the CONSORT guidelines
and approved by the Teesside University Health Research Ethics Sub-Committee. The VR
intervention used the Facebook Oculus Quest 2 VR headset with the fitness game "FitXR," while
the non-VR group completed traditional HIIT that replicated the same movements as in the VR
game.
Participants and Recruitment A purposive sampling method was used to recruit ten healthy
physiotherapy students from Teesside University. Participants had to lead an active
lifestyle, defined as performing either 150 minutes of moderate exercise weekly or 75 minutes
of vigorous-intensity aerobic exercise, and have no prior experience with VR-based exercise.
Those with medical conditions preventing them from exercising or those unable to give
informed consent were excluded. Participants were recruited via email through a gatekeeper,
indicating their willingness to participate by contacting the research physiotherapist
directly. The allocation to either the VR or non-VR group was stratified by gender and
block-randomised in blocks of five using a computer-generated software (Research Randomizer).
Interventions
Exergaming via VR:
Participants in the VR group used the Facebook Oculus Quest 2 and "FitXR," a fitness game in
high-speed HIIT class mode. The 15-minute session included functional movements such as
squats, lunges, and trunk rotations while trying to hit virtual targets by punching. The
training session had a 10-second rest between each interval, and participants followed
instructions from a virtual trainer.
Traditional HIIT:
The non-VR group followed a traditional HIIT session that mirrored the movements from the
"FitXR" game. Participants replicated movements such as squats with punches, as pre-recorded
and displayed on a laptop. The session matched the VR group's overall duration and intervals.
Safety and Blinding To ensure safety while using the VR headset, participants were restricted
to a 3m by 3m safety boundary. Stepping out of the boundary automatically paused the game,
activating external cameras to provide real-world visibility. Blinding was not feasible due
to the nature of the intervention, but the researcher responsible for the data analysis was
unaware of the group allocations to reduce bias.
Outcome Measures
Physiological Outcomes:
Heart Rate: Measured using a Polar RS400 monitor. Exercise intensity was calculated as a
percentage of the maximum heart rate (%HRmax) and heart rate reserve (%HRR). The intensity
was categorised according to American Heart Association standards.
Rating of Perceived Exertion (RPE): Measured using Borg's CR-10 scale every five minutes.
Scores ranged from 0 (rest) to 10 (maximum effort).
Psychological Outcomes:
Flow State Scale (FSS): Assessed engagement and motivation using a 36-item questionnaire with
nine subscales. Participants rated items on a 5-point Likert scale from 1 (strongly disagree)
to 5 (strongly agree). The subscales measured challenge-skill balance, action-awareness
merging, clear goals, unambiguous feedback, and other factors.
Statistical Analysis A frequentist approach was employed with SPSS software (version 26).
Independent-samples t-tests were used with a significance level of 0.05, and effect sizes
were expressed using Cohen's d (small = 0.2, moderate = 0.5, large = 0.8). Bayesian data
analysis was conducted with JASP software to assess the robustness of findings. Bayes factors
were calculated to compare evidence for alternative versus null hypotheses. Robustness checks
were performed to ensure results remained consistent across different prior distributions.
Sample Size and Feasibility Given that this was a pilot study, the emphasis was placed on
assessing feasibility rather than ensuring the study was fully powered. As such, recruitment
spanned a period of time with the objective of enrolling as many patients as possible,
without specifying a target participant number to achieve optimal study power. An aim of this
study was, therefore, to explore feasibility and preliminary outcomes, which will inform
future, larger-scale research
Conclusion This pilot study provides preliminary evidence that immersive VR training can
offer a feasible alternative to traditional HIIT, achieving comparable physiological benefits
with potentially greater intrinsic motivation and engagement. Future studies with larger
sample sizes are needed to validate these findings and assess VR's impacts on diverse
clinical populations.