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- Ensaio Clínico NCT07727382
Effects of an ACWR-Guided Load Management Intervention on Time-Loss Injury Incidence in Chinese Elite Youth Footballers: A Cluster Randomised Controlled Trial (ACWR Injury)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Background: Injury prevention in elite youth football is a public health and performance priority. Approximately two-thirds of players sustain at least one time-loss injury annually, with lower extremity injuries predominating. The acute:chronic workload ratio (ACWR) is widely used in sport science as a practical decision-support tool, yet experimental evidence for its effectiveness in reducing injury incidence remains limited and conflicting, particularly in Asian adolescent populations.
Objectives: This cluster-randomised controlled trial evaluates whether a multi-component ACWR-guided load management intervention reduces time-loss injury incidence in Chinese elite youth football players compared with routine practice.
Study Design: A prospective, two-arm, parallel-group, cluster-randomised controlled trial with 1:1 allocation, stratified by age group (U15/U17/U19).
Participants: Twenty-eight elite youth football teams (U15-U19, n=774, 45.2% female) from 28 academies in Henan Province.
Intervention: The intervention comprises real-time ACWR feedback, automated alerts for values outside the 0.8-1.3 range, coach education workshops, and structured load-adjustment protocols. Control teams follow routine practice without ACWR-derived feedback.
Primary Outcome: Time-loss injury incidence rate per 1000 athlete-exposure hours.
Secondary Outcomes: (1) Severe injury incidence (≥28 days lost); (2) Injury burden (days lost per 1000 h); (3) Proportion of lower-extremity injuries; (4) Proportion of non-contact injuries.
Sample Size: 28 teams (14 per arm) with 774 players (median 27 per team, range 22-31), providing 80% power to detect a 25% reduction in injury incidence (IRR=0.75) with α=0.05 and ICC=0.05.
Statistical Analysis: Mixed-effects Poisson regression with ICC adjustment, Fine-Gray competing risk models, shared frailty Cox models, Kaplan-Meier survival analysis, and E-value sensitivity analysis.
Ethics: The study protocol was approved by the Xinyang Agriculture and Forestry University Ethics Committee (XYAFUAE2024021). Written informed consent was obtained from all participants and their parents/legal guardians.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Jun Li
- Número de telefone: 13526075609
- E-mail: 2005210010@xyafu.edu.cn
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age 13-19 years Member of a participating U15, U17, or U19 team No injury precluding full participation at enrolment Provided written informed consent (parental consent for minors)
Exclusion Criteria:
- Injury precluding full participation at enrolment Failure to provide informed consent Age outside 13-19 years
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: ACWR Intervention vs Control Trial
Coaches in this group will plan and adjust all training sessions based on published Acute:Chronic Workload Ratio (ACWR) load management principles.
Player training load data will be monitored using a commercially available athlete management system.
The intervention will be implemented for the duration of the complete season.
The ACWR will be used to guide training prescription, with the goal of managing the players' acute and chronic workloads to reduce injury risk
|
Intervention teams implement a structured ACWR-guided load management protocol for the entire season. The protocol comprises four components: Component 1 - Load Monitoring: After each training session and match, players rate perceived exertion on the Borg CR-10 scale. Session-RPE (sRPE) is calculated as duration (minutes) × RPE score. Data are recorded using a dedicated mobile application (CoachMe v3.2). Research staff provide technical support and weekly reminders. Component 2 - Weekly ACWR Reports: The research team generates weekly ACWR reports for each player. Reports are emailed to head coaches each Monday morning, covering the preceding week's data. Component 3-Automated Alerts and Load-Adjustment Recommendations: Coaches receive automated alerts when a player's ACWR falls below 0.8 or exceeds 1.3. When ACWR < 0.8, a progressive increase in training load (10-20% weekly) is suggested. When ACWR > 1.3, coaches are instructed to implement a 10-20% load reduction at the next session, |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Time-loss injury incidence rate per 1000 athlete-exposure hours.
Prazo: From enrolment to the end of the 10-month competitive season
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Definition: Consistent with the football injury consensus statement, a time-loss injury is defined as any physical impairment sustained during structured football training or competitive matches that prevents a player from full participation in subsequent training sessions or matches.
Injuries occurring outside football activities are not recorded.
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From enrolment to the end of the 10-month competitive season
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
Outros números de identificação do estudo
- XYAFUAE2026021
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
All of the individual participant data collected during the trial, after deidentification. This will include, but is not limited to: baseline demographic and anthropometric data, training load metrics (e.g., acute:chronic workload ratio [ACWR] and its components), time-loss injury incidence and severity data, and exposure hours.
Additional documents to be made available: Study Protocol, Statistical Analysis Plan (SAP), and Informed Consent Form (ICF).
Time frame: Data will be available beginning 9 months and ending 36 months following publication of the primary results.
Access criteria: Data will be made available to researchers who provide a methodologically sound proposal for the purpose of achieving the aims in the approved proposal. Proposals should be directed to the Principal Investigator. To gain access, data requesters will need to sign a data access agreement
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CIF
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