- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07749196
Virtual Reality Exergaming During Work Breaks in Office Employees
Virtual Reality Exergaming for Workplace Breaks: Acute Physical and Affective Responses, Leisure Experience, and Usability in Office Employees
The goal of this trial is to learn how different exercise formats used during workplace breaks affect the immediate physical and emotional responses of office employees. It will also examine participants' leisure experience and the usability of virtual reality exercise.
The main questions it aims to answer are:
- Do gamified virtual reality exercise, instructor-led virtual reality exercise, and traditional video exercise produce different changes in heart rate and perceived effort?
- Do these exercise formats produce different changes in how pleasant or unpleasant and how activated participants feel?
- Do the exercise formats differ in positive and negative experiences, flow, exercise enjoyment, and satisfaction with the activity?
- Do the two virtual reality formats differ in system usability and virtual reality-related discomfort?
Researchers will compare the three exercise formats to identify differences in participants' immediate responses and experiences.
Participants will:
- Complete three 10-minute exercise sessions on separate days and in a randomly assigned order
- Take part in a gamified virtual reality boxing session, an instructor-led virtual reality exercise session, and a traditional video exercise session
- Wear a heart rate monitor and complete brief questionnaires before and after the sessions
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Antalya
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Antalya, Antalya, Turquía (Türkiye), 07070
- Akdeniz University Faculty of Sports Sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Aged between 24 and 60 years
- Being a healthy adult employed full-time in an administrative office-based position at Akdeniz University
- Having worked full-time in the current administrative unit for at least one year
- Having a low or moderate physical activity level according to the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
- Not engaging in regular exercise
- Having no health condition that contraindicates participation in physical activity according to the Physical Activity Readiness Questionnaire (PAR-Q)
- Not having regularly used active virtual reality technologies within the previous six months
Exclusion Criteria:
- A history of epilepsy, migraine, vertigo, or vestibular disorder
- A history of dizziness, nausea, or similar discomfort during virtual reality exposure
- Current use of antidepressants or medications that affect the central nervous system
- A history of neurological, cardiovascular, or orthopedic disease, except for controlled hypertension
- Pregnancy
- Presence of a visual or hearing impairment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Sequence 1: GVRE-SVRE-TVE
Participants assigned to this sequence will complete gamified virtual reality exergaming in Period 1, serious virtual reality exergaming in Period 2, and traditional video exercise in Period 3.
Each intervention will be completed once in a separate session.
Consecutive sessions will be separated by a washout period of at least 24 hours.
|
Participants will complete one 10-minute gamified virtual reality exergaming session using the FitXR BOX mode, a Meta Quest 3 headset, and handheld controllers.
Participants will perform boxing-based whole-body movements involving virtual targets.
The intervention includes game-related elements such as scoring, pacing, performance tracking, and real-time visual and auditory feedback.
Participants will complete one 10-minute serious virtual reality exergaming session using the FitXR SCULPT mode and a Meta Quest 3 headset.
Participants will follow structured whole-body exercise movements demonstrated by a virtual instructor.
The condition emphasizes movement guidance and exercise performance and contains minimal game-related elements.
Participants will complete one 10-minute video-based exercise session.
Participants will follow an instructor displayed on a two-dimensional screen without using a virtual reality headset.
The exercise content will correspond to the serious virtual reality exergaming condition but will not include virtual reality interaction or game-related elements.
This intervention will serve as the active comparison condition.
|
|
Experimental: Sequence 2: SVRE-TVE-GVRE
Participants assigned to this sequence will complete serious virtual reality exergaming in Period 1, traditional video exercise in Period 2, and gamified virtual reality exergaming in Period 3.
Each intervention will be completed once in a separate session.
Consecutive sessions will be separated by a washout period of at least 24 hours.
|
Participants will complete one 10-minute gamified virtual reality exergaming session using the FitXR BOX mode, a Meta Quest 3 headset, and handheld controllers.
Participants will perform boxing-based whole-body movements involving virtual targets.
The intervention includes game-related elements such as scoring, pacing, performance tracking, and real-time visual and auditory feedback.
Participants will complete one 10-minute serious virtual reality exergaming session using the FitXR SCULPT mode and a Meta Quest 3 headset.
Participants will follow structured whole-body exercise movements demonstrated by a virtual instructor.
The condition emphasizes movement guidance and exercise performance and contains minimal game-related elements.
Participants will complete one 10-minute video-based exercise session.
Participants will follow an instructor displayed on a two-dimensional screen without using a virtual reality headset.
The exercise content will correspond to the serious virtual reality exergaming condition but will not include virtual reality interaction or game-related elements.
This intervention will serve as the active comparison condition.
|
|
Experimental: Sequence 3: TVE-GVRE-SVRE
Participants assigned to this sequence will complete traditional video exercise in Period 1, gamified virtual reality exergaming in Period 2, and serious virtual reality exergaming in Period 3.
Each intervention will be completed once in a separate session.
Consecutive sessions will be separated by a washout period of at least 24 hours.
|
Participants will complete one 10-minute gamified virtual reality exergaming session using the FitXR BOX mode, a Meta Quest 3 headset, and handheld controllers.
Participants will perform boxing-based whole-body movements involving virtual targets.
The intervention includes game-related elements such as scoring, pacing, performance tracking, and real-time visual and auditory feedback.
Participants will complete one 10-minute serious virtual reality exergaming session using the FitXR SCULPT mode and a Meta Quest 3 headset.
Participants will follow structured whole-body exercise movements demonstrated by a virtual instructor.
The condition emphasizes movement guidance and exercise performance and contains minimal game-related elements.
Participants will complete one 10-minute video-based exercise session.
Participants will follow an instructor displayed on a two-dimensional screen without using a virtual reality headset.
The exercise content will correspond to the serious virtual reality exergaming condition but will not include virtual reality interaction or game-related elements.
This intervention will serve as the active comparison condition.
|
|
Experimental: Sequence 4: GVRE-TVE-SVRE
Participants assigned to this sequence will complete gamified virtual reality exergaming in Period 1, traditional video exercise in Period 2, and serious virtual reality exergaming in Period 3.
Each intervention will be completed once in a separate session.
Consecutive sessions will be separated by a washout period of at least 24 hours.
|
Participants will complete one 10-minute gamified virtual reality exergaming session using the FitXR BOX mode, a Meta Quest 3 headset, and handheld controllers.
Participants will perform boxing-based whole-body movements involving virtual targets.
The intervention includes game-related elements such as scoring, pacing, performance tracking, and real-time visual and auditory feedback.
Participants will complete one 10-minute serious virtual reality exergaming session using the FitXR SCULPT mode and a Meta Quest 3 headset.
Participants will follow structured whole-body exercise movements demonstrated by a virtual instructor.
The condition emphasizes movement guidance and exercise performance and contains minimal game-related elements.
Participants will complete one 10-minute video-based exercise session.
Participants will follow an instructor displayed on a two-dimensional screen without using a virtual reality headset.
The exercise content will correspond to the serious virtual reality exergaming condition but will not include virtual reality interaction or game-related elements.
This intervention will serve as the active comparison condition.
|
|
Experimental: Sequence 5: TVE-SVRE-GVRE
Participants assigned to this sequence will complete traditional video exercise in Period 1, serious virtual reality exergaming in Period 2, and gamified virtual reality exergaming in Period 3.
Each intervention will be completed once in a separate session.
Consecutive sessions will be separated by a washout period of at least 24 hours.
|
Participants will complete one 10-minute gamified virtual reality exergaming session using the FitXR BOX mode, a Meta Quest 3 headset, and handheld controllers.
Participants will perform boxing-based whole-body movements involving virtual targets.
The intervention includes game-related elements such as scoring, pacing, performance tracking, and real-time visual and auditory feedback.
Participants will complete one 10-minute serious virtual reality exergaming session using the FitXR SCULPT mode and a Meta Quest 3 headset.
Participants will follow structured whole-body exercise movements demonstrated by a virtual instructor.
The condition emphasizes movement guidance and exercise performance and contains minimal game-related elements.
Participants will complete one 10-minute video-based exercise session.
Participants will follow an instructor displayed on a two-dimensional screen without using a virtual reality headset.
The exercise content will correspond to the serious virtual reality exergaming condition but will not include virtual reality interaction or game-related elements.
This intervention will serve as the active comparison condition.
|
|
Experimental: Sequence 6: SVRE-GVRE-TVE
Participants assigned to this sequence will complete serious virtual reality exergaming in Period 1, gamified virtual reality exergaming in Period 2, and traditional video exercise in Period 3.
Each intervention will be completed once in a separate session.
Consecutive sessions will be separated by a washout period of at least 24 hours.
|
Participants will complete one 10-minute gamified virtual reality exergaming session using the FitXR BOX mode, a Meta Quest 3 headset, and handheld controllers.
Participants will perform boxing-based whole-body movements involving virtual targets.
The intervention includes game-related elements such as scoring, pacing, performance tracking, and real-time visual and auditory feedback.
Participants will complete one 10-minute serious virtual reality exergaming session using the FitXR SCULPT mode and a Meta Quest 3 headset.
Participants will follow structured whole-body exercise movements demonstrated by a virtual instructor.
The condition emphasizes movement guidance and exercise performance and contains minimal game-related elements.
Participants will complete one 10-minute video-based exercise session.
Participants will follow an instructor displayed on a two-dimensional screen without using a virtual reality headset.
The exercise content will correspond to the serious virtual reality exergaming condition but will not include virtual reality interaction or game-related elements.
This intervention will serve as the active comparison condition.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Resting and Mean Exercise Heart Rate
Periodo de tiempo: During each of the three experimental sessions: during the 3-minute pre-intervention rest period and continuously throughout the 10-minute intervention
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Heart rate will be continuously recorded in beats per minute (bpm) using a Polar H10 chest-strap sensor.
For each experimental condition, resting heart rate will be defined as the mean heart rate recorded during the 3-minute rest period immediately before the intervention.
Mean exercise heart rate will be defined as the mean heart rate recorded throughout the 10-minute exercise session.
The effects of the intervention conditions on heart rate will be evaluated by comparing resting and mean exercise heart rate values across the gamified virtual reality exergaming, serious virtual reality exergaming, and traditional video exercise conditions.
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During each of the three experimental sessions: during the 3-minute pre-intervention rest period and continuously throughout the 10-minute intervention
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Change in Rating of Perceived Exertion
Periodo de tiempo: Immediately before and immediately after each 10-minute intervention during each of the three experimental sessions
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Perceived exertion will be assessed using the Borg Rating of Perceived Exertion Scale, which ranges from 6 (no exertion or very, very light exertion) to 20 (maximal exertion).
The outcome will be saved as the post-intervention score and the pre-intervention score for each condition.
A higher positive value indicates a greater increase in perceived exertion.
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Immediately before and immediately after each 10-minute intervention during each of the three experimental sessions
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Change in Felt Arousal Assessed With the Felt Arousal Scale
Periodo de tiempo: Immediately before and immediately after each 10-minute intervention during each of the three experimental sessions
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Felt arousal will be assessed using the single-item Felt Arousal Scale, which ranges from 1 (low arousal) to 6 (high arousal).
The outcome will be saved as the post-intervention score and the pre-intervention score for each condition.
A higher positive value indicates a greater increase in felt arousal.
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Immediately before and immediately after each 10-minute intervention during each of the three experimental sessions
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Change in Affective Valence Assessed With the Feeling Scale
Periodo de tiempo: Immediately before and immediately after each 10-minute intervention during each of the three experimental sessions
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Affective valence will be assessed using the single-item Feeling Scale.
The Feeling Scale measures current affective valence on an 11-point bipolar scale ranging from -5 (very bad; minimum possible score) to +5 (very good; maximum possible score).
Higher scores indicate more positive affective valence and a better outcome.
The scale will be administered immediately before and immediately after each intervention.
Pre-intervention and post-intervention scores will be retained as separate observations and analyzed across the three intervention conditions; no separate change score will be calculated.
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Immediately before and immediately after each 10-minute intervention during each of the three experimental sessions
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Positive and Negative Experience
Periodo de tiempo: Immediately before and immediately after each 10-minute intervention during each of the three experimental sessions
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Positive and negative experience will be assessed using the 12-item Scale of Positive and Negative Experience (SPANE).
The scale consists of six positive-experience items and six negative-experience items, each rated on a 5-point scale from 1 (never) to 5 (always).
Separate scores will be calculated for the positive experience subscale (SPANE-P) and the negative experience subscale (SPANE-N).
Each subscale score ranges from 6 to 30.
Higher SPANE-P scores indicate greater positive experience, whereas higher SPANE-N scores indicate greater negative experience.
The scale will be administered immediately before and immediately after each intervention, and pre- and post-intervention scores for both subscales will be compared across the three intervention conditions.
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Immediately before and immediately after each 10-minute intervention during each of the three experimental sessions
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Flow State
Periodo de tiempo: Immediately after each 10-minute intervention during each of the three experimental sessions
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Flow state will be assessed using the nine-item state version of the Short Flow State Scale-2.
The scale evaluates dimensions of the immediate flow experience, including challenge-skill balance, action-awareness merging, clear goals, unambiguous feedback, concentration, sense of control, loss of self-consciousness, transformation of time, and autotelic experience.
Each item is rated on a 5-point scale from 1 (do not agree at all) to 5 (completely agree).
Higher total scores indicate a more intense flow experience.
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Immediately after each 10-minute intervention during each of the three experimental sessions
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Activity Satisfaction
Periodo de tiempo: Immediately after each 10-minute intervention during each of the three experimental sessions
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Activity satisfaction will be assessed using the three-item Activity Satisfaction Scale.
Each item is rated on a 7-point scale from 1 (strongly disagree) to 7 (completely agree).
Higher scores indicate greater satisfaction with the exercise activity completed during the experimental session.
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Immediately after each 10-minute intervention during each of the three experimental sessions
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System Usability
Periodo de tiempo: Immediately after each of the two 10-minute virtual reality interventions: GVRE and SVRE
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Perceived system usability will be assessed using the 10-item System Usability Scale.
Each item is rated on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree).
The scale evaluates participants' perceptions of the effectiveness, efficiency, ease of use, and overall usability of the virtual reality system.
Higher scores indicate better perceived system usability.
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Immediately after each of the two 10-minute virtual reality interventions: GVRE and SVRE
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Virtual Reality Discomfort
Periodo de tiempo: Immediately after each of the two 10-minute virtual reality interventions: GVRE and SVRE
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Virtual reality-related discomfort will be assessed using the nine-item Virtual Reality Discomfort Scale.
The scale evaluates two dimensions of discomfort: oculomotor symptoms, such as eye strain and blurred vision, and disorientation symptoms, such as dizziness and nausea.
Each item is rated on a 4-point scale from 0 (none) to 3 (severe).
Higher scores indicate greater virtual reality-related discomfort.
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Immediately after each of the two 10-minute virtual reality interventions: GVRE and SVRE
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Exercise Enjoyment
Periodo de tiempo: Immediately after each 10-minute intervention during each of the three experimental sessions
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Exercise enjoyment will be assessed using the eight-item Physical Activity Enjoyment Scale (PACES-8).
Each of the eight bipolar items is scored from 1 to 7 in the direction of greater enjoyment.
The item scores are summed to produce a total score ranging from 8 (minimum possible score) to 56 (maximum possible score).
Higher total scores indicate greater exercise enjoyment and a better outcome.
The scale will be administered immediately after each intervention.
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Immediately after each 10-minute intervention during each of the three experimental sessions
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Tennur Yerlisu Lapa, PhD, Akdeniz University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 1456730.03.60
- 325K759 (Otro número de subvención/financiamiento: The Scientific and Technological Research Council of Türkiye)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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