Immersive Virtual Reality Bicycling for Healthy Adults

Healthy Clinical Trial

Official title:

Enhancing Exercise Intensity, Motivation and Enjoyment for Younger and Older Healthy Adults (VCycle-Competition-HA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05253703
• Other study ID #: Pro2021002091
• Status: Completed
• Phase: N/A
• Start date: February 16, 2022
• Est. completion date: June 7, 2022

Study information

• Verified date: August 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study has four objectives about healthy younger and older adults during immersive virtual reality bicycling:

Determine the effect of visual feedback and competition for younger healthy adults during virtual bicycling on user experience, motivation, enjoyment, perception of effort, and neuromuscular and cardiovascular intensity

Determine the effect of visual feedback and competition for older healthy adults during virtual bicycling on user experience, motivation, enjoyment, perception of effort, and neuromuscular and cardiovascular intensity

Compare younger and older during visual feedback and competition bicycling in terms of: user experience, motivation, enjoyment, perception of effort, neuromuscular and cardiovascular intensity

Determine if attention differs in visual feedback bicycling compared to competition bicycling for younger and older healthy adults

Description:

Participants will attend one session lasting about 1.5 hours. They will complete a competitiveness assessment and a questionnaire about physical activity. They will then exercise in three different virtual reality augmented bicycling conditions while wearing a head mounted display (goggles). Each of the three conditions will last approximately 5 minutes and will be followed by questionnaires about the participant's experience.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 7, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• 21-75 years old,

• Able to ride a stationary upright bicycle,

• Able to sign informed consent.

Exclusion Criteria:

• Have a recent history of severe heart disease, severe lung disease, uncontrolled diabetes, traumatic brain injury or any other neurological disorder

• Are unable to follow directions or sign a consent form,

• Do not have adequate vision or hearing ability to see or hear a television,

• Have unstable medical condition or musculoskeletal disorder such as severe arthritis, recent knee surgery, hip surgery, or any other condition that the investigators determine would impair the ability to ride the bicycle,

• Have any other medical condition that prevents bicycling,

• Have moderate depression (score of 10 or more on PHQ-9 screening tool)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Virtual reality bicycling
This is a single arm study in which all participants will execute the same three bicycling tasks over one session (see arm/group description).

Locations

Country	Name	City	State
United States	Rutgers School of Health Professions	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	International Physical Activity Questionnaire (IPAQ)	The IPAQ is a 27-item questionnaire to measure levels of physical activity. There are 4 main domains of physical activity related to: occupation, transportation, housework, leisure activity. Scores range from 0-19,278 with higher scores representing higher levels of physical activity over the past 7 days.	Collected once at start of the session
Other	Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a 9-item questionnaire to rate depression (scored from 0-27 with a lower score indicating lower levels of depression).	Collected once during screening
Primary	Neuromuscular Intensity (Bicycling cadence, revolutions per minute) - Feedback	Bicycling cadence collected continuously (1 value per second, 1 Hz)	Session 1 - During the 5-minute feedback bout
Primary	Neuromuscular Intensity (Bicycling cadence, revolutions per minute) - Self-Competition	Bicycling cadence collected continuously (1 value per second, 1 Hz)	Session 1 - During the 5-minute self-competition bout
Primary	Neuromuscular Intensity (Bicycling cadence, revolutions per minute) - Other-Competition	Bicycling cadence collected continuously (1 value per second, 1 Hz)	Session 1 - During the 5-minute other-competition bout
Primary	Motivation (Intrinsic Motivation Inventory) - Feedback	Intrinsic Motivation Inventory - enjoyment, competence, effort, and value subscales (16 questions total). Scores in each subscale are averaged, with a minimum score of 1 and a maximum score of 7. Higher scores indicate higher motivation.	Session 1 - Immediately after completing the 5-minute feedback bout
Primary	Motivation (Intrinsic Motivation Inventory) - Self-Competition	Intrinsic Motivation Inventory - enjoyment, competence, effort, and value subscales (16 questions total). Scores in each subscale are averaged, with a minimum score of 1 and a maximum score of 7. Higher scores indicate higher motivation.	Session 1 - Immediately after completing the 5-minute self-competition bout
Primary	Motivation (Intrinsic Motivation Inventory) - Other-Competition	Intrinsic Motivation Inventory - enjoyment, competence, effort, and value subscales (16 questions total). Scores in each subscale are averaged, with a minimum score of 1 and a maximum score of 7. Higher scores indicate higher motivation.	Session 1 - Immediately after completing the 5-minute other-competition bout
Primary	Cardiovascular Intensity (Heart rate, beats per minute) - Feedback	Heart rate collected continuously (1 value per second, 1 Hz)	Session 1 - During the 5-minute feedback bout
Primary	Cardiovascular Intensity (Heart rate, beats per minute) - Self-Competition	Heart rate collected continuously (1 value per second, 1 Hz)	Session 1 - During the 5-minute self-competition bout
Primary	Cardiovascular Intensity (Heart rate, beats per minute) - Other-Competition	Heart rate collected continuously (1 value per second, 1 Hz)	Session 1 - During the 5-minute other-competition bout
Primary	Visual Attention (infrared eye-tracking data representing gaze positions in a 3D coordinate plane to be used in calculating dwell time in regions of interest in the virtual simulation) - Feedback	3D gaze positions measured continuously (50 values per second, 50 Hz)	Session 1 - During the 5-minute feedback bout
Primary	Visual Attention (infrared eye-tracking data representing gaze positions in a 3D coordinate plane to be used in calculating dwell time in regions of interest in the virtual simulation) - Self-Competition	3D gaze positions measured continuously (50 values per second, 50 Hz)	Session 1 - During the 5-minute self-competition bout
Primary	Visual Attention (infrared eye-tracking data representing gaze positions in a 3D coordinate plane to be used in calculating dwell time in regions of interest in the virtual simulation) - Other-Competition	3D gaze positions measured continuously (50 values per second, 50 Hz)	Session 1 - During the 5-minute other-competition bout
Secondary	Rating of Perceived Exertion - Feedback (start)	Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.	Session 1 - Immediately at the start (0-minute mark) of the 5-minute feedback bout
Secondary	Rating of Perceived Exertion - Feedback (middle)	Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.	Session 1 - At the midpoint (2.5-minute mark) of the 5-minute feedback bout
Secondary	Rating of Perceived Exertion - Feedback (end)	Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.	Session 1 - At the endpoint (5-minute mark) of the 5-minute feedback bout
Secondary	Rating of Perceived Exertion - Self-Competition (start)	Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.	Session 1 - Immediately at the start (0-minute mark) of the 5-minute self-competition bout
Secondary	Rating of Perceived Exertion - Self-Competition (middle)	Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.	Session 1 -At the midpoint (2.5-minute mark) of the 5-minute self-competition bout
Secondary	Rating of Perceived Exertion - Self-Competition (end)	Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.	Session 1 -At the end (5-minute mark) of the 5-minute self-competition bout
Secondary	Rating of Perceived Exertion - Other-Competition (start)	Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.	Session 1 -Immediately at the start (0-minute mark) of the 5-minute other-competition bout
Secondary	Rating of Perceived Exertion - Other-Competition (middle)	Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.	Session 1 -At the midpoint (2.5-minute mark) of the 5-minute other-competition bout
Secondary	Rating of Perceived Exertion - Other-Competition (end)	Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.	Session 1 -At the end (5-minute mark) of the 5-minute other-competition bout
Secondary	Competitiveness (Multidimensional Competitive Orientation Inventory)	Measured once using the Multidimensional Competitive Orientation Inventory consisting of 12 items from 4 subscales (hyper competitive, self-developmental, anxious, lack of interest) For each subscale, mean scores range from 1-6 with higher scores representing higher levels of that subscale metric.	Session 1 - Collected once at start of session
Secondary	Ranking of Perceived Effort	Once, after completing all 3 bicycling conditions, participants will be asked in which of the 3 bicycling conditions they felt they worked the hardest. They will rank the 3 conditions with a score from 1-3, with a 1 indicating the condition in which they felt they worked the hardest and a 3 indicating the condition in which they felt they worked the least hard.	Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
Secondary	Ranking of Enjoyment	Once, after completing all 3 bicycling conditions, participants will be asked which of the 3 bicycling conditions they liked the best. They will rank the 3 conditions with a score from 1-3, with a 1 indicating the condition they liked the best and a 3 indicating the condition they liked the least.	Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
Secondary	Audio recordings of exercise experience	Once, after completing all 3 bicycling conditions, participants will be asked about their exercise experience. Their responses will be audio recorded to be coded and analyzed qualitatively for themes.	Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition