- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05253703
Immersive Virtual Reality Bicycling for Healthy Adults
Enhancing Exercise Intensity, Motivation and Enjoyment for Younger and Older Healthy Adults (VCycle-Competition-HA)
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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New Jersey
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Newark, New Jersey, United States, 07107
- Rutgers School of Health Professions
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Virtual Reality Bicycling
This is a single arm study in which all participants will execute the same three bicycling tasks over one session.
Exercise intensity and enjoyment are measured while participants bicycle in a virtual reality environment (wearing virtual reality goggles) in three different conditions lasting approximately 5 minutes each.
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This is a single arm study in which all participants will execute the same three bicycling tasks over one session (see arm/group description).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuromuscular Intensity (Bicycling cadence, revolutions per minute) - Feedback
Time Frame: Session 1 - During the 5-minute feedback bout
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Bicycling cadence collected continuously (1 value per second, 1 Hz)
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Session 1 - During the 5-minute feedback bout
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Neuromuscular Intensity (Bicycling cadence, revolutions per minute) - Self-Competition
Time Frame: Session 1 - During the 5-minute self-competition bout
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Bicycling cadence collected continuously (1 value per second, 1 Hz)
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Session 1 - During the 5-minute self-competition bout
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Neuromuscular Intensity (Bicycling cadence, revolutions per minute) - Other-Competition
Time Frame: Session 1 - During the 5-minute other-competition bout
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Bicycling cadence collected continuously (1 value per second, 1 Hz)
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Session 1 - During the 5-minute other-competition bout
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Motivation (Intrinsic Motivation Inventory) - Feedback
Time Frame: Session 1 - Immediately after completing the 5-minute feedback bout
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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.
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Session 1 - Immediately after completing the 5-minute feedback bout
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Motivation (Intrinsic Motivation Inventory) - Self-Competition
Time Frame: Session 1 - Immediately after completing the 5-minute self-competition bout
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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.
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Session 1 - Immediately after completing the 5-minute self-competition bout
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Motivation (Intrinsic Motivation Inventory) - Other-Competition
Time Frame: Session 1 - Immediately after completing the 5-minute other-competition bout
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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.
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Session 1 - Immediately after completing the 5-minute other-competition bout
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Cardiovascular Intensity (Heart rate, beats per minute) - Feedback
Time Frame: Session 1 - During the 5-minute feedback bout
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Heart rate collected continuously (1 value per second, 1 Hz)
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Session 1 - During the 5-minute feedback bout
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Cardiovascular Intensity (Heart rate, beats per minute) - Self-Competition
Time Frame: Session 1 - During the 5-minute self-competition bout
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Heart rate collected continuously (1 value per second, 1 Hz)
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Session 1 - During the 5-minute self-competition bout
|
|
Cardiovascular Intensity (Heart rate, beats per minute) - Other-Competition
Time Frame: Session 1 - During the 5-minute other-competition bout
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Heart rate collected continuously (1 value per second, 1 Hz)
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Session 1 - During the 5-minute other-competition bout
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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
Time Frame: Session 1 - During the 5-minute feedback bout
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3D gaze positions measured continuously (50 values per second, 50 Hz)
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Session 1 - During the 5-minute feedback bout
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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
Time Frame: Session 1 - During the 5-minute self-competition bout
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3D gaze positions measured continuously (50 values per second, 50 Hz)
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Session 1 - During the 5-minute self-competition bout
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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
Time Frame: Session 1 - During the 5-minute other-competition bout
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3D gaze positions measured continuously (50 values per second, 50 Hz)
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Session 1 - During the 5-minute other-competition bout
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ranking of Perceived Effort
Time Frame: Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
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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.
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Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
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Ranking of Enjoyment
Time Frame: Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
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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.
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Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
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Audio recordings of exercise experience
Time Frame: Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
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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.
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Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
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Rating of Perceived Exertion - Feedback (start)
Time Frame: Session 1 - Immediately at the start (0-minute mark) of the 5-minute feedback bout
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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.
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Session 1 - Immediately at the start (0-minute mark) of the 5-minute feedback bout
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Rating of Perceived Exertion - Feedback (middle)
Time Frame: Session 1 - At the midpoint (2.5-minute mark) of the 5-minute feedback bout
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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.
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Session 1 - At the midpoint (2.5-minute mark) of the 5-minute feedback bout
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Rating of Perceived Exertion - Feedback (end)
Time Frame: Session 1 - At the endpoint (5-minute mark) of the 5-minute feedback bout
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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.
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Session 1 - At the endpoint (5-minute mark) of the 5-minute feedback bout
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Rating of Perceived Exertion - Self-Competition (start)
Time Frame: Session 1 - Immediately at the start (0-minute mark) of the 5-minute self-competition bout
|
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.
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Session 1 - Immediately at the start (0-minute mark) of the 5-minute self-competition bout
|
|
Rating of Perceived Exertion - Self-Competition (middle)
Time Frame: Session 1 -At the midpoint (2.5-minute mark) of the 5-minute self-competition bout
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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.
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Session 1 -At the midpoint (2.5-minute mark) of the 5-minute self-competition bout
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Rating of Perceived Exertion - Self-Competition (end)
Time Frame: Session 1 -At the end (5-minute mark) of the 5-minute self-competition bout
|
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.
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Session 1 -At the end (5-minute mark) of the 5-minute self-competition bout
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Rating of Perceived Exertion - Other-Competition (start)
Time Frame: Session 1 -Immediately at the start (0-minute mark) of the 5-minute other-competition bout
|
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
|
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Rating of Perceived Exertion - Other-Competition (middle)
Time Frame: Session 1 -At the midpoint (2.5-minute mark) of the 5-minute other-competition bout
|
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
|
|
Rating of Perceived Exertion - Other-Competition (end)
Time Frame: Session 1 -At the end (5-minute mark) of the 5-minute other-competition bout
|
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
|
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Competitiveness (Multidimensional Competitive Orientation Inventory)
Time Frame: Session 1 - Collected once at start of session
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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.
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Session 1 - Collected once at start of session
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
International Physical Activity Questionnaire (IPAQ)
Time Frame: Collected once at start of the session
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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.
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Collected once at start of the session
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Patient Health Questionnaire (PHQ-9)
Time Frame: Collected once during screening
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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
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Collaborators and Investigators
Investigators
- Principal Investigator: Judith E Deutsch, Rutgers School of Health Professions
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro2021002091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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