- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Brașov County
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Brasov, Brașov County, Romania, 500036
- Transilvania University of Brașov
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mean Weekly Exercise Adherence
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Physical Activity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FEFSM-411-2026-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
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