- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Brașov County
-
Brasov, Brașov County, Romênia, 500036
- Transilvania University of Brașov
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean Weekly Exercise Adherence
Prazo: From intervention initiation through the end of Week 8
|
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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Total Physical Activity
Prazo: Baseline and at the end of Week 8
|
Total physical activity was assessed using the International Physical Activity Questionnaire Short Form (IPAQ-SF) and expressed as MET-minutes per week.
|
Baseline and at the end of Week 8
|
|
WHO-5 Well-Being Score
Prazo: Baseline and at the end of Week 8
|
Wellbeing was assessed using the WHO-5 Well-Being Index.
|
Baseline and at the end of Week 8
|
|
Countermovement Jump Best Height
Prazo: Baseline and at the end of Week 8
|
Best countermovement jump height was assessed using OptoJump Next and expressed in centimeters.
|
Baseline and at the end of Week 8
|
|
Countermovement Jump Mean Height
Prazo: Baseline and at the end of Week 8
|
Mean countermovement jump height was assessed using OptoJump Next and expressed in centimeters.
|
Baseline and at the end of Week 8
|
|
Simple Reaction Time
Prazo: Baseline and at the end of Week 8
|
Description: Lower-limb simple reaction time was assessed using BlazePod and expressed in milliseconds.
|
Baseline and at the end of Week 8
|
|
Choice Reaction Time
Prazo: Baseline and at the end of Week 8
|
Lower-limb choice reaction time was assessed using BlazePod and expressed in milliseconds.
|
Baseline and at the end of Week 8
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FEFSM-411-2026-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .