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)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Jun Li
- Telefonnummer: 13526075609
- E-mail: 2005210010@xyafu.edu.cn
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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, |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time-loss injury incidence rate per 1000 athlete-exposure hours.
Tidsramme: From enrolment to the end of the 10-month competitive season
|
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.
|
From enrolment to the end of the 10-month competitive season
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- XYAFUAE2026021
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .