Clinical trial NCT05294237: Injury Prevention in Danish Youth Handball
Official title: Injury Prevention in Danish Youth Handball - a Hybrid Effectiveness-implementation Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adherence, Sports Injury Prevention Exercises
Athletic Injuries
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Danish Handball Federation
First posted: 2022-03-24
Enrollment: 950
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of this hybrid-effectiveness-implementation cluster randomised study is to investigate if a supported implementation of an injury prevention exercise program (Happy program) involving a train-the-trainer workshop and coach support during the season is superior to an unsupported implementation of the Happy program involving the availability of the program on webpages, in improving adherence (volume, frequency, duration) of the Happy program among coaches for young (11-17 years of age) Danish female and male handball players during one handball season. Secondary aims are to investigate if the supported implementation is superior to the unsupported implementation in improving behavioural outcomes among the coaches and in reducing the risk for new ankle, knee, and shoulder injuries among young (11-17 years of age) Danish female and male handball players during one handball season. Further, the investigators aim to evaluate how and why adherence and behavioural determinants towards use of the Happy program might improve (or not).


Eligibility criteria: Inclusion Criteria:

* playing in youth teams from the age groups under (u)13, u15, and u17
* playing in handball club with at least four teams in the desired age groups

Exclusion Criteria:

-

Primary outcomes:
measure: Adherence volume at team level
timeFrame: Measured weekly over 7 months
measure: Shoulder, knee and ankle injuries using the Oslo Sports Trauma Research Center Health problems Questionnaire (OSTRC-H2)
timeFrame: Measured weekly over 7 months
Secondary outcomes:
measure: Adherence volume of the Happy warm-up components at team level
timeFrame: Assessed weekly over 7 months
measure: Adherence volume of the Happy resistance training components at team level
timeFrame: Assessed weekly over 7 months
measure: Adherence volume of the Happy resistance training components at player level
timeFrame: Assessed weekly over 7 months
measure: Substantial shoulder, knee and ankle injuries using the Oslo Sports Trauma Research Center Health problems Questionnaire (OSTRC-H2)
timeFrame: Assessed weekly over 7 months
measure: Health Action Process Approach (HAPA) Questionnaire responses
timeFrame: Will be assessed at baseline, mid-season (3 months after baseline) and at end season (7 months)
measure: Determinants of Implementation Behavior Questionnaire (DIBQ) responses
timeFrame: Will be assessed at baseline, mid-season (3 months after baseline) and at end season (7 months)
Other outcomes:
measure: Training volume
timeFrame: Assessed weekly over 7 months
measure: Match volume
timeFrame: Assessed weekly over 7 months
measure: Illness outcomes using the Oslo Sports Trauma Research Center Health problems Questionnaire (OSTRC-H2)
timeFrame: Assessed weekly over 7 months
measure: Injury outcomes using the Oslo Sports Trauma Research Center Health problems Questionnaire (OSTRC-H2)
timeFrame: Assessed weekly over 7 months
measure: Adherence duration at team level
timeFrame: Assessed weekly over 7 months
measure: Adherence duration of the the Happy warm-up components at team level
timeFrame: Assessed weekly over 7 months
measure: Adherence duration of the Happy resistance training components at team level
timeFrame: Assessed weekly over 7 months
measure: Component fidelity at team level
timeFrame: Assessed weekly over 7 months
measure: Adherence duration of the Happy resistance training components at player level
timeFrame: Assessed weekly over 7 months
measure: Adherence frequency at team level
timeFrame: Assessed weekly over 7 months
measure: Adherence frequency of the Happy warm-up components at team level
timeFrame: Assessed weekly over 7 months
measure: Adherence frequency of the Happy resistance training components at team level
timeFrame: Assessed weekly over 7 months
measure: Adherence frequency of the Happy resistance training components at player level
timeFrame: Assessed weekly over 7 months
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
state: Southern Denmark
Study officials:
affiliation: University of Southern Denmark, Department of Sports Science and Biomechanics
name: Merete Møller, PhD
role: PRINCIPAL_INVESTIGATOR
References: