Examining the Effects of Virtual Reality Exercise on Mental Health

Physical Activity Clinical Trial

— UVIC VR Fit  

Official title:

Examining the Effects of Virtual Reality Exercise on Mental Health Outcomes: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06367439
• Other study ID #: FN-10984
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: University of Victoria
• Contact: Ryan Rhodes, PhD
• Phone: 250-472-5288
• Email: rrhodes[@]uvic.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this investigation is to examine the effectiveness of virtual reality (VR) exercise (Supernatural exergaming via Meta Platforms Technologies, LLC) for improving mental health as indicated by (1) both short-term mood (one exercise bout) and long-term (10-weeks) mood (depression and anxiety symptoms), (2) well-being (i.e., vitality) over a 10-week period, and (3) perceived cognitive function over a 10-week period. The secondary purpose of this study is to examine the effectiveness of VR exercise for improving both physical activity behaviour and physical activity motivation (attitudes, capability, opportunity, behavioural regulation, habit, identity) over a 10-week period. The tertiary purpose is to examine whether key motivational variables (e.g., attitudes, capability, opportunity, behavioural regulation, habit, identity) regarding Supernatural use explain variability in Supernatural use over time.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

Inclusion Criteria:

• Age 19-64
• Living in the Greater Victoria area
• Have a stable Wi-Fi connection at home
• Experience no health constraints that limit moderate-to-vigorous physical activity participation as identified by the Physical Activity Readiness Questionnaire (PARQ+).
• Currently participating in less than 75 minutes of vigorous physical activity per week (as per Canadian physical activity guidelines)
• Be willing to travel into the Behavioural Medicine Lab on the UVic campus
• Be the only member of their household to participate in the study, past or present

Exclusion Criteria:

• If participant is flagged by the PARQ+ and is not cleared to participate in physical activity by their physician they are ineligible to participate
• Does not meet any of the above inclusion criteria

Related Conditions & MeSH terms

• Mental Health
• Mood
• Physical Activity

Intervention

Behavioral:
• Supernatural Condition
Participants will complete a Supernatural tutorial (YouTube instruction and in-headset gameplay instruction/practice) and will complete a 18-20 minute affect measurement medium intenstiy Supernatural physical activity session in the Behavioural Medicine Lab (UVic).
• Supernatural Condition
Participants will be provided a Meta Quest 3 Headset and Supernatural account for 10 weeks. Participants will be instructed to participate in 75 minutes of medium intensity Supernatural physical activity (equivalent to 75 minutes of vigorous physical activity) per week in their own home.

Locations

Country	Name	City	State
Canada	Behavioural Medicine Lab	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of Victoria	Meta Platforms, Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (22)

Anderson DF, Cychosz CM. Development of an exercise identity scale. Percept Mot Skills. 1994 Jun;78(3 Pt 1):747-51. doi: 10.1177/003151259407800313. — View Citation

Borg, G. (1998). Borg's perceived exertion and pain scales. Human Kinetics.

Bostic, T. J., Rubio, D. M., & Hood, M. (2000). A validation of the subjective vitality scale using structural equation modelling. Social Indicators Research, 52(3), 313-324. https://doi.org/10.1111/j.1541-0072.1977.tb01338.x

Costa, P. T., & McCrae, R. R. (1992). Revised neo personality inventory and Neo Five-Factor Inventory. Research Psychologists Press.

Courneya KS, Jones LW, Rhodes RE, Blanchard CM. Effects of different combinations of intensity categories on self-reported exercise. Res Q Exerc Sport. 2004 Dec;75(4):429-33. doi: 10.1080/02701367.2004.10609176. No abstract available. — View Citation

Courneya, K. S. (1994). Predicting repeated behavior from intention: The issue of scale correspondence. Journal of Applied Social Psychology, 24(7), 580-594. https://doi.org/10.1111/j.1559-1816.1994.tb00601.x

Cox A, Rhodes RE. Increasing Physical Activity in Empty Nest and Retired Populations Online: A Randomized Feasibility Study. J Aging Phys Act. 2023 Jun 1;31(6):909-922. doi: 10.1123/japa.2022-0285. Print 2023 Dec 1. — View Citation

Gardner B, Abraham C, Lally P, de Bruijn GJ. Towards parsimony in habit measurement: testing the convergent and predictive validity of an automaticity subscale of the Self-Report Habit Index. Int J Behav Nutr Phys Act. 2012 Aug 30;9:102. doi: 10.1186/1479-5868-9-102. — View Citation

Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6. — View Citation

Hardy, C. J., & Rejeski, W. J. (1989). Not what, but how one feels: The measurement of affect during exercise. Journal of Sport & Exercise Psychology, 11, 304-317.

IPAQ. (2004). International physical activity prevalence study environmental survey module. Retrieved August 10 from http://www-rohan.sdsu.edu/faculty/sallis/IPAQIPS.pdf

Lithopoulos A, Zhang CQ, Williams DM, Rhodes RE. Development and Validation of a Two-component Perceived Control Measure. Ann Behav Med. 2023 Feb 4;57(2):175-184. doi: 10.1093/abm/kaac033. — View Citation

Peres, S. C., Pham, T., & Phillips, R. (2013). Validation of the system usability scale (sus): SUS in the wild. Proceedings of the Human Factors and Ergonomics Society, 1, 192-196. https://doi.org/10.1177/1541931213571043

Rhodes RE, Courneya KS. Investigating multiple components of attitude, subjective norm, and perceived control: an examination of the theory of planned behaviour in the exercise domain. Br J Soc Psychol. 2003 Mar;42(Pt 1):129-46. doi: 10.1348/014466603763276162. — View Citation

Rhodes RE, Lithopoulos A. The Physical Activity Regulation Scale: Development and validity testing. Health Psychol. 2023 Jun;42(6):378-387. doi: 10.1037/hea0001283. — View Citation

Rhodes, R. E., & Courneya, K. S. (2004). Differentiating motivation and control in the Theory of Planned Behavior. Psychology, Health, and Medicine, 9(2), 205-215. https://doi.org/10.1080/13548500410001670726

Ryan RM, Frederick C. On energy, personality, and health: subjective vitality as a dynamic reflection of well-being. J Pers. 1997 Sep;65(3):529-65. doi: 10.1111/j.1467-6494.1997.tb00326.x. — View Citation

Spinella M. Self-rated executive function: development of the executive function index. Int J Neurosci. 2005 May;115(5):649-67. doi: 10.1080/00207450590524304. — View Citation

Svebak, S., & Murgatroyd, S. (1985). Metamotivational dominance: A multimethod validation of reversal theory constructs. Journal of Personality and Social Psychology, 48(1), 107-116.

Wilhelm, P., & Schoebi, D. (2007). Assessing mood in daily life: Structural validity, sensitivity to change, and reliability of a short-scale to measure three basic dimensions of mood. European Journal of Psychological Assessment, 23(4), 258-267. https://doi.org/10.1027/1015-5759.23.4.258

Wilson, P. M., & Muon, S. (2008). Psychometric properties of the Exercise Identity Scale in a university sample. International Journal of Sport and Exercise Psychology, 6(2), 115-131. https://doi.org/10.1080/1612197X.2008.9671857

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived exertion	Using the modified Borg Rating of Perceived Exertion scale, participants will rate how hard they feel they are physically exerting themselves on a scale anchored by 0 (nothing at all) to 10 (very strong) during the exercise session (Supernatural VR exercise and treadmill running) (Borg, 1998). Participants will be verbally prompted to respond to the scale during exercise.	~3.5 minute intervals (post song) during exercise. 5 measurements total.
Other	Supernatural Target Accuracy	Participants will receive a target accuracy score (i.e., number of targets successfully striked/punched) for each workout they complete. Scores range from 0 to 100%, with higher scores reflecting a more positive outcome.	Once during in-lab Supernatural orientation (tutorial workout), and after each of the five songs completed during the in-lab Supernatural workout.
Other	Attitude towards physical activity	Participants will respond to three items assessing affective attitudes towards physical activity (boring-fun, unpleasant-pleasant, unenjoyable-enjoyable) and three items assessing instrumental attitudes towards physical activity (useless-useful, harmful-beneficial, unwise-wise), for the next five weeks (Rhodes & Courneya, 2003). They will respond to the six items on a seven point Likert-type scale. The two subscales will be mean scored (potential range 1-7), with higher scores reflecting more positive affective attitudes and more positive instrumental attitudes towards physical activity and more positive outcomes.	Baseline, week 5, week 10
Other	Attitude towards Supernatural physical activity	Participants will respond to three items assessing affective attitudes towards Supernatural physical activity (boring-fun, unpleasant-pleasant, unenjoyable-enjoyable) and three items assessing instrumental attitudes towards Supernatural physical activity (useless-useful, harmful-beneficial, unwise-wise), for the next four/five weeks (Rhodes & Courneya, 2003). They will respond to the six items on a seven point Likert-type scale. The two subscales will be mean scored (potential range 1-7), with higher scores reflecting more positive affective attitudes and more positive instrumental attitudes towards Supernatural physical activity and more positive outcomes.	Week 1, Week 5, Week 10
Other	Perceived opportunity for physical activity	Perceived opportunity to be regularly physically active over the next five weeks will be assessed using a three item scale (Lithopoulos et al., 2023). Participants will respond to the items using a seven point Likert-type scale anchored by 1 (strongly disagree) to 7 (strongly agree). The three items will be mean scored (potential range 1-7), with higher scores indicating higher perceived opportunity for physical activity and a more positive outcome.	Baseline, week 5, week 10
Other	Perceived opportunity for Supernatural physical activity	Perceived opportunity to participate in regular Supernatural physical activity over the next four/five weeks will be assessed using an adapted three item scale (Lithopoulos et al., 2023). Participants will respond to the items using a seven point Likert-type scale anchored by 1 (strongly disagree) to 7 (strongly agree). The three items will be mean scored (potential range 1-7), with higher scores indicating higher perceived opportunity for Supernatural physical activity and a more positive outcome.	Week 1, week 5, week 10
Other	Perceived capability for physical activity	Perceived capability for regular physical activity over the next five weeks will be assessed using a four item scale (Lithopoulos et al., 2023). Participants will respond to the four items using a seven point Likert-type scale anchored by 1 (strongly disagree) to 7 (strongly agree). The four items will be mean scored (potential range 1-7), with higher scores indicating higher perceived capability for physical activity and a more positive outcome.	Baseline, week 5, week 10
Other	Perceived capability for Supernatural physical activity	Perceived capability for regular Supernatural physical activity over the next four/five weeks will be assessed using a four item scale (Lithopoulos et al., 2023). Participants will respond to the four items using a seven point Likert-type scale anchored by 1 (strongly disagree) to 7 (strongly agree). The four items will be mean scored (potential range 1-7), with higher scores indicating higher perceived capability for Supernatural physical activity and a more positive outcome.	Week 1, week 5, week 10
Other	Intentions for physical activity behaviour	Participants will complete two items. First participants will report the number of minutes of moderate-to-vigorous physical activity they intend to complete in the next five weeks with a minimum score of 0 minutes and higher values reflecting a more positive outcome(Courneya, 1994). Second, participants will report the strength of their desire to participate in regular physical activity over the next five weeks using a seven-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher scores (potential range 1-7) will reflect greater intention to participate in regular physical activity and a more positive outcome (Rhodes & Courneya, 2004).	Baseline, week 5, week 10
Other	Intention for regular Supernatural physical activity behaviour	Participants will complete two items. First participants will report the number of minutes of medium intensity Supernatural physical activity they intend to complete in the next four/five weeks with a minimum score of 0 minutes and higher values reflecting a more positive outcome (Courneya, 1994). Second, participants will report the strength of their desire to participate in regular Supernatural physical activity over the next four/five weeks using a seven-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher scores (potential range 1-7) will reflect greater intention to participate in regular physical activity and a more positive outcome (Rhodes & Courneya, 2004).	Week 1, week 5, week 10
Other	Behavioural regulation of physical activity behaviour	Participants will respond to the 14-item physical activity regulation scale using a seven point Likert-type scale anchored by 1 (strongly disagree) to 7 (strongly agree) (Rhodes & Lithopoulos, 2023). The 14-item measure includes four subscales, which are proactive regulation (4 items), reactive regulation (4 items), social monitoring (3 items), and self-monitoring (3 items).The four subscales will be mean scored (potential range 1-7), with higher scores indicating higher levels of physical activity behaviour regulation and a more positive outcome.	Baseline, week 5, week 10
Other	Behavioural regulation of Supernatural physical activity	Participants will respond to the 14-item physical activity regulation scale adapted for Supernatural physical activity using a seven point Likert-type scale anchored by 1 (strongly disagree) to 7 (strongly agree) (Rhodes & Lithopoulos, 2023). The 14-item measure includes four subscales, which are proactive regulation (4 items), reactive regulation (4 items), social monitoring (3 items), and self-monitoring (3 items).The four subscales will be mean scored (potential range 1-7), with higher scores indicating higher levels of Supernatural physical activity behaviour regulation and a more positive outcome.	Week 1, week 5, week 10
Other	Physical activity habit	Participants will complete the four item self-report behavioural automaticity index (Gardner et al., 2012). Participants will respond to four items on a five point Likert-type scale anchored by 1 (strongly disagree) to 5 (strongly agree). The four items will be mean scored (potential range 1-5), with higher scores reflecting a stronger physical activity habit and a more positive outcome.	Baseline, week 5, week 10
Other	Supernatural physical activity habit	Participants will complete the four item self-report behavioural automaticity index (Gardner et al., 2012), adapted for Supernatural physical activity. Participants will respond to four items on a five point Likert-type scale anchored by 1 (strongly disagree) to 5 (strongly agree). The four items will be mean scored (potential range 1-5), with higher scores reflecting a stronger Supernatural physical activity habit and a more positive outcome.	Week 1, week 5, week 10
Other	Physical activity identity	Physical activity identity will be assessed using the three item self-identity subscale of the exercise identity scale (Anderson & Cychosz, 1994; Wilson & Muon, 2008). Participants will respond to the three items using a seven point Likert-type scale anchored by 1 (strongly disagree) to 7 (strongly agree). The three items will be mean scored (potential range 1-7), with higher score reflecting a greater physical activity self-identity and a more positive outcome.	Baseline, week 5, week 10
Other	Supernatural physical activity identity	Supernatural physical activity identity will be assessed using an adapted three item self-identity subscale of the exercise identity scale (Anderson & Cychosz, 1994; Wilson & Muon, 2008). Participants will respond to the three items using a seven point Likert-type scale anchored by 1 (strongly disagree) to 7 (strongly agree). The three items will be mean scored (potential range 1-7), with higher score reflecting a greater Supernatural physical activity self-identity and a more positive outcome.	Week 1, week 5, week 10
Other	Physical activity behaviour	In reference to the past five weeks, participants will report the number of times per week (on average) they engaged in mild, moderate, and vigorous physical activity using the Godin Leisure Time Exercise Questionnaire (Godin & Shephard, 1985), and the average duration of mild, moderate, and vigorous physical activity sessions (Courneya et al., 2004). Consistent with Courneya et al. (2004), the researchers will create an indicator of average weekly moderate-to-vigorous physical activity minutes (in past 5 weeks) for each participant using the following equation: (number of moderate bouts x average minutes per bout) + (number of vigorous bouts x average minutes per bout). The scores will have a minimum value of 0 minutes, with more minutes indicating greater participation in moderate-to-vigorous physical activity and a more positive outcome.	Baseline, week 5, week 10
Other	Supernatural physical activity behaviour	In reference to the past one/four/five weeks, participants will report the number of times per week (on average) they engaged in low, medium, and high intensity Supernatural physical activity using the Godin Leisure Time Exercise Questionnaire (Godin & Shephard, 1985), and the average duration of the low, medium, and high intensity Supernatural physical activity sessions (Courneya et al., 2004). Consistent with Courneya et al. (2004), the researchers will create an indicator of average weekly medium-high intensity Supernatural physical activity minutes for each participant using the following equation: (number of medium bouts x average minutes per bout) + (number of high bouts x average minutes per bout). The scores will have a minimum value of 0 minutes, with more minutes indicating greater participation in Supernatural physical activity and a more positive outcome.	Week 1, Week 5, week 10
Other	Weekly Supernatural Physical Activity Behaviour	Participants in the Supernatural condition will log their Supernatural VR physical activity (intensity and duration for each day of the week) at the end of each week. Scores will have a minimum value of 0 minutes, with more minutes indicating greater participation in Supernatural physical activity and a more positive outcome.	Week 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10
Other	Direct assessment of Supernatural physical activity behaviour	The Meta Quest Move application (within Meta Quest 3 headset) estimates the amount of calories expended and 'move minutes' for each application in the headset. The calories expended and move minutes (within a particular time frame) in Supernatural will be extracted from the Meta Quest Move application for each participant. Meta Quest Move does underestimate the number of calories expended during a bout of physical activity and will therefore represent a proxy measure for Supernatural engagement time. A total score for calories burned and 'move minutes' will be recorded for each week of the study, with minimum values of 0 minutes and 0 calories and more minutes and calories expended indicating greater participation in Supernatural physical activity and a more positive outcome.	Week 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10
Other	Direct assessment of physical activity behaviour	Accelerometers (wGT3X-BT ActiGraph) will provide direct assessments of participants' moderate-to-vigorous physical activity. Participants will wear the accelerometer for seven days at baseline and seven days post-week 10. The scores will have a minimum value of 0 minutes with more minutes will indicate greater participation in moderate-to-vigorous physical activity and a more positive outcome.	Baseline and Week 10
Other	Feasibility and Acceptability of Supernatural and the Meta Quest 3 headset	Participants in the Supernatural condition will complete 9 items regarding the feasibility and acceptability of the Supernatural VR exercise game and the Meta Quest 3 headset. Participants will respond to each item on a five point Likert scale anchored by 1 (strongly disagree) to 5 (strongly agree). The 9 items will be mean scored (potential range 1-5), with higher scores indicating higher levels of feasibility and acceptability for both Supernatural and the Meta Quest 3 and a more positive outcomes. Items were derived from a previous Feasibility study (Cox & Rhodes, 2023).	Week 10
Other	Supernatural usability	Participants in the Supernatural condition will complete an adapted 10-item system usability scale for the Supernatural VR exercise game, responding to each item on a five point Likert scale anchored by 1 (strongly disagree) to 5 (strongly agree) (Peres et al., 2013).The 10-items will be mean scored (potential range 1-5), with higher scores indicating higher levels of Supernatural usability and a more positive outcome.	Week 10
Other	Meta Quest 3 headset usability	Participants in the Supernatural condition will complete an adapted 10-item system usability scale for the Meta Quest 3 headset, responding to each item on a five point Likert scale anchored by 1 (strongly disagree) to 5 (strongly agree) (Peres et al., 2013).The 10-items will be mean scored (potential range 1-5), with higher scores indicating higher levels of Meta Quest 3 usability and a more positive outcome.	Week 10
Other	Personality	Participants will respond to the neuroticism (12 items), extraversion (12 items), and conscientiousness (12 items) subscales in the five factor inventory (Costa & McCrae, 1992). Participants will respond to the 36 personality related items on a five point Likert-type scale anchored by 0 (strongly disagree) to 4 (strongly agree). Each subscale will be mean scored (potential range 0-4), with higher scores reflecting a higher degree of the personality trait.	Week 5
Other	Physical Activity Environment	The environmental module of the International Physical Activity Prevalence Study (IPS) will be used to assess a participants environment for walking and bicycling ability . Participants will be able to respond 17 items on a four point Likert-type scale anchored by 1 (strongly disagree) to 4 (strongly agree). Items will be mean scored (potential range 1 to 4) with higher scores reflecting a more favourable environment for physical activity participation.	Week 10
Primary	Depression and anxiety mood symptoms	Participants will respond to the 14-item Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983), which includes a depression subscale (7 items) and an anxiety subscale (7 items). Participants will respond to the 14-items using a four point (0-3) Likert-type scale. The two subscales will be mean scored (potential range 0-3), with higher scores reflecting higher depression and anxiety and more negative outcomes.	Baseline, week 5, week 10
Primary	Well-being: subjective vitality	Subjective vitality will be assessed using a six-item subjective vitality scale (Bostic et al., 2000; Ryan & Frederick, 1997). Participants will respond to the six subjective vitality items on a seven point Likert-type scale anchored by 1 (not at all true) to 7 (very true). The six items will be mean scored (potential range 1-7), with higher scores reflecting higher subjective vitality and a more positive outcome.	Baseline, week 5, week 10
Primary	Perceived cognitive function	Participants will respond to the organization (5 items) and strategic planning (7 items) subscales of the executive function index using a five point Likert-type scale anchored by 1 (Not at all) to 5 (Very much) (Spinella, 2005). The two subscales will be mean scored (potential range 1-5), with higher scores reflecting higher organization and strategic planning and more positive outcomes.	Baseline, week 5, week 10
Secondary	Short-term Mood	Participants will respond to the positive mood valence (2 items), calmness (2 items), and energy (2 items) sub-scales of the multidimensional mood questionnaire using a seven point Likert-type scale (Wilhelm & Schoebi, 2007). The three subscales will be mean scored (potential range 0-6), with higher scores indicating a more positive mood (valence, calmness, energy) and a more positive outcome.	Pre (baseline) and post in-lab physical activity; through lab completion (2 hours).
Secondary	Core Affect Measure - Feeling Scale	Participants will complete a single item affect measure on an 11-point Likert-type scale anchored by -5 (very bad) to +5 (very good) to examine the affective response to exercise (Supernatural VR exercise or treadmill running) (Hardy & Rejeski, 1989). Higher scores will reflect more positive affective responses and a more positive outcome. Participants will be verbally prompted to respond to the scale during exercise (Supernatural VR exercise or treadmill exercise).	Baseline (pre exercise session), at ~3.5 minute intervals during exercise (post song), and at 1.5 and 3 minutes post exercise). 8 measurements total
Secondary	Core Affect Measure - Felt Arousal Scale	Participants will complete a single item arousal measure on a 6-point Likert-type scale anchored by 1 (low arousal) to 6 (high arousal) (Svebak & Murgatroyd, 1985). Participants will be verbally prompted to respond to the scale during exercise (Supernatural VR exercise or treadmill exercise).	Baseline (pre exercise session), ~ at 3.5 minute intervals during exercise (post song), and at 1.5 and 3 minutes post exercise). 8 measurements total