NCT06464406

Brief 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 (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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2024

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

June 13, 2024

Last Update Submit

June 19, 2024

Conditions

Keywords

virtual realitycardiorespiratory fitnessanaerobic thresholdbicycle ergometer test

Outcome Measures

Primary Outcomes (2)

  • VO2peak

    The highest level of oxygen uptake averaged over a 20-second period.

    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).

    Assessed during the exercise test for each condition.

Secondary Outcomes (9)

  • Peak power

    Assessed during the exercise test for each condition.

  • Total test time

    Assessed during the exercise test for each condition.

  • RPE

    Assessed throughout the exercise test for each condition (at the end of the warm-up and end of every even-numbered stage)..

  • Affective Valence

    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

    Assessed during the exercise test for each condition.

  • +4 more secondary outcomes

Study Arms (2)

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.

Behavioral: Virtual Reality conditionBehavioral: 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.

Behavioral: Virtual Reality conditionBehavioral: Control condition

Interventions

Participants will watch a video on a virtual reality headset during the completion of the maximal cardiorespiratory exercise test.

Control condition completed firstVirtual Reality condition completed first

Participants will complete the maximal cardiorespiratory exercise test under control conditions without video, music, or other distractions.

Control condition completed firstVirtual Reality condition completed first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augusta University

Augusta, Georgia, 30909, United States

RECRUITING

Study Officials

  • Andrew R Moore, PhD

    Augusta University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew R Moore, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
It is not possible to mask the participant or data collection personnel from the conditions because the Virtual Reality condition requires that the headset be worn. Metabolic data and resulting outcomes (i.e. VO2peak value) will be analyzed by independent research assistants who will be blinded to the condition under which the data were gathered.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 18, 2024

Study Start

June 7, 2024

Primary Completion

October 7, 2024

Study Completion

October 7, 2024

Last Updated

June 21, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations