- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Brașov County
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Brasov, Brașov County, Rumunsko, 500036
- Transilvania University of Brașov
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
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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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Aktivní komparátor: 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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mean Weekly Exercise Adherence
Časové okno: 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.
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From intervention initiation through the end of Week 8
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Total Physical Activity
Časové okno: 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 MET-minutes per week.
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Baseline and at the end of Week 8
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WHO-5 Well-Being Score
Časové okno: Baseline and at the end of Week 8
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Wellbeing was assessed using the WHO-5 Well-Being Index.
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Baseline and at the end of Week 8
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Countermovement Jump Best Height
Časové okno: 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.
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Baseline and at the end of Week 8
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Countermovement Jump Mean Height
Časové okno: 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.
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Baseline and at the end of Week 8
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Simple Reaction Time
Časové okno: 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.
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Baseline and at the end of Week 8
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Choice Reaction Time
Časové okno: 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.
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Baseline and at the end of Week 8
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- FEFSM-411-2026-01
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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