- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07825948
AI-Personalized Digital Exercise for University Students (AIPDEUS)
Effects of an AI-Personalized Digital Exercise Programme on Adherence, Physical Activity, and Wellbeing Among University Students: An 8-Week Randomized Controlled Trial
This study evaluated whether an AI-personalized digital exercise programme could improve exercise adherence, physical activity, wellbeing, and physical performance among university students compared with a standardized digital exercise programme. University students were randomly assigned to one of two digital exercise programmes for 8 weeks. The AI-personalized programme adjusted exercise recommendations using participant characteristics, previous exercise adherence, readiness, pain, safety information, and physical performance measures. The comparator provided a standardized digital exercise programme without adaptive weekly personalization. The primary outcome was mean weekly exercise adherence. Secondary outcomes included physical activity, wellbeing, countermovement jump performance, lower-limb reaction time, engagement, usability, and safety.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This was an 8-week, two-group randomized controlled trial conducted among undergraduate students at Transilvania University of Brașov, Romania. The study compared an AI-personalized digital exercise programme with a standardized digital exercise programme delivered within the same digital study environment.
Participants assigned to the AI-personalized group received exercise recommendations through MoveAI-Student version 2.1.0 using the version-controlled v1.3-adaptive system. The system combined prespecified safety rules with a supervised recommendation model. Personalization used participant characteristics, sport participation, weekly training volume, countermovement jump performance, simple and choice reaction time, readiness, pain, previous-week adherence, and safety information. Exercise recommendations could specify session frequency, duration, intensity, and additional emphasis on lower-limb power or reactive drills. Recommendations were updated once per intervention week. Progression was limited by predefined safety rules, and exercise load could be reduced when pain or an adverse-event flag was present. Human override of recommendations was permitted when required.
Participants assigned to the standardized digital comparator used the same digital study environment but did not receive the adaptive weekly prescription procedure. The comparator programme prescribed three exercise sessions per week, with each session lasting 35 minutes.
The primary outcome was mean weekly exercise adherence, calculated from completed sessions relative to prescribed sessions across the 8-week intervention. Secondary outcomes included total physical activity assessed with the International Physical Activity Questionnaire Short Form, WHO-5 wellbeing, countermovement jump performance, simple reaction time, choice reaction time, moderate-to-vigorous physical activity, application engagement, satisfaction, perceived usefulness, usability, sitting time, body weight, body mass index, and adverse events.
The study was designed to estimate the effect of the adaptive programme as a complete intervention compared with standardized digital exercise. It was not designed to isolate the independent effect of the algorithm from differences in exercise prescription or completed exercise exposure.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Brașov County
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Brasov, Brașov County, Rumania, 500036
- Transilvania University of Brașov
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Undergraduate student currently enrolled at Transilvania University of Brașov. Age 18 to 65 years at baseline.
- Written informed consent provided before any study-specific procedure.
- Able to safely complete the standardized countermovement jump protocol using OptoJump.
- Able to safely complete the lower-limb simple and choice reaction-time protocols using BlazePod.
- Access to a smartphone compatible with the study application.
- Willing to use the study application throughout the 8-week intervention.
- Able to attend both baseline and post-intervention assessments.
Exclusion Criteria:
- Acute musculoskeletal injury or pain that made jumping or rapid lower-limb responses unsafe.
- Medical condition contraindicating exercise participation or study testing.
- Use of medication known to affect neuromuscular performance or reaction time, as defined in the approved protocol.
- Concurrent participation in another interventional exercise or digital-health trial.
- Inability or unwillingness to complete the required assessments or the 8-week digital intervention.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: AI-Personalized Digital Exercise Programme
Participants received an 8-week digital exercise programme delivered through MoveAI-Student version 2.1.0. Exercise prescriptions were personalized using the v1.3-adaptive system and updated weekly based on participant characteristics, previous-week adherence, readiness, pain, safety information, and physical performance measures. Recommendations could modify exercise frequency, duration, intensity, and task emphasis. |
An 8-week digital exercise intervention using MoveAI-Student version 2.1.0 and the v1.3-adaptive system. Initial exercise prescriptions ranged from three to five sessions per week, 30 to 45 minutes per session, at moderate-to-vigorous intensity. Recommendations were updated weekly using adherence and safety information. Prescriptions could modify session frequency, duration, intensity, and emphasis on lower-limb power or reactive drills. Predefined safety rules limited weekly progression and allowed reduced exercise load when pain or an adverse-event flag was present. |
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Comparador activo: Standardized Digital Exercise Programme
Participants received an 8-week standardized digital exercise programme through the same study application. The programme prescribed three exercise sessions per week, with each session lasting 35 minutes. Participants did not receive the adaptive weekly personalization procedure used in the experimental group. |
An 8-week standardized digital exercise intervention delivered through the same study application. Participants were prescribed three exercise sessions per week, with each session lasting 35 minutes. The programme did not use the adaptive weekly prescription procedure applied in the AI-personalized group. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean Weekly Exercise Adherence
Periodo de tiempo: From intervention initiation through the end of Week 8
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Weekly adherence was calculated as completed exercise sessions relative to prescribed exercise sessions within each intervention week. The participant-level mean across the 8-week intervention was used as the primary outcome. |
From intervention initiation through the end of Week 8
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total Physical Activity Assessed With the International Physical Activity Questionnaire-Short Form
Periodo de tiempo: Baseline and at the end of Week 8
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Total physical activity was assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) and expressed as metabolic equivalent of task (MET)-minutes per week. Total MET-minutes per week were calculated from reported walking, moderate-intensity activity, and vigorous-intensity activity. The minimum possible value is 0 MET-minutes/week. There is no fixed upper limit for this derived physical-activity measure. Higher values indicate a greater amount of total physical activity. |
Baseline and at the end of Week 8
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5-item World Health Organization Well-Being Index (WHO-5) Score
Periodo de tiempo: Baseline and at the end of Week 8
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Well-being was assessed using the 5-item World Health Organization Well-Being Index (WHO-5). Each of the five items is scored from 0 to 5, producing a raw total score from 0 to 25. The raw score was multiplied by 4 to obtain the reported score ranging from 0 to 100. Higher scores indicate better subjective well-being. |
Baseline and at the end of Week 8
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Countermovement Jump Best Height
Periodo de tiempo: Baseline and at the end of Week 8
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Best countermovement jump height was assessed using OptoJump Next and expressed in centimeters. |
Baseline and at the end of Week 8
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Countermovement Jump Mean Height
Periodo de tiempo: Baseline and at the end of Week 8
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Mean countermovement jump height was assessed using OptoJump Next and expressed in centimeters. |
Baseline and at the end of Week 8
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Simple Reaction Time
Periodo de tiempo: Baseline and at the end of Week 8
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Description: Lower-limb simple reaction time was assessed using BlazePod and expressed in milliseconds. |
Baseline and at the end of Week 8
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Choice Reaction Time
Periodo de tiempo: Baseline and at the end of Week 8
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Lower-limb choice reaction time was assessed using BlazePod and expressed in milliseconds. |
Baseline and at the end of Week 8
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FEFSM-411-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Deidentified individual participant data underlying the results reported in the published article will be available upon reasonable request. Shared data may include baseline characteristics, exercise adherence, physical activity, WHO-5 wellbeing, countermovement jump outcomes, simple and choice reaction time, engagement and usability measures, and adverse-event data, as applicable.
Marco de tiempo para compartir IPD
Beginning 3 months after publication of the study results and available for 5 years.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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