Injury Prevention in Danish Youth Handball

Athletic Injuries Clinical Trial

Official title:

Injury Prevention in Danish Youth Handball - a Hybrid Effectiveness-implementation Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05294237
• Other study ID #: SDU-2021-57-(2089)
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2022
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 950
• Est. completion date: June 30, 2023
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Athletic Injuries
• Wounds and Injuries

Intervention

Behavioral:
• Happy program
The Happy program consists of handball specific warm-up components and resistance training components and will be available online.
• Support
The support consists of a coach workshop at the beginning of the season and the opportunity for additional support for the coaches throughout the season.

Locations

Country	Name	City	State
Denmark	University of Southern Denmark	Odense	Southern Denmark

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Danish Handball Federation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Training volume	Number of training hours will be used to assess the player's exposure to handball training.; Will be assessed weekly as a add on to the Oslo Sports Trauma Research Center Overuse Injury Questionnaire distributed electronically to the players via an application.	Assessed weekly over 7 months
Other	Match volume	Number of match hours will be used to assess the player's exposure to handball matches.; Match volume will be assessed weekly as a add on to the Oslo Sports Trauma Research Center Overuse Injury Questionnaire distributed electronically to the players via an application.	Assessed weekly over 7 months
Other	Illness outcomes using the Oslo Sports Trauma Research Center Health problems Questionnaire (OSTRC-H2)	Illness will be defined is a complaint or disorder experienced by an athlete, not related to the injury. Illnesses include health- related problems in physical (eg, influenza), mental (eg, depression), or social well-being or removal or loss of vital elements (air, water, warmth), following the 2020 consensus statement from the International Olympic Committee.; Illness status will be monitored weekly during the season using the Oslo Sports Trauma Research Center Overuse Injury Questionnaire distributed electronically to the players via an application. The questionnaire also measures exposure to handball, both training and match, during the last seven days.	Assessed weekly over 7 months
Other	Injury outcomes using the Oslo Sports Trauma Research Center Health problems Questionnaire (OSTRC-H2)	Other injury outcomes will be all injuries.; Injuries will be defined as any tissue damage or other derangement of normal physical function due to participation in handball, resulting from rapid or repetitive transfer of kinetic energy, following the 2020 consensus statement from the International Olympic Committee.; Injury status will be monitored weekly during the season using the Oslo Sports Trauma Research Center Overuse Injury Questionnaire distributed electronically to the players via an application. The questionnaire also measures exposure to handball, both training and match, during the last seven days.	Assessed weekly over 7 months
Other	Adherence duration at team level	How long the Happy components have been delivered (adherence duration) will be evaluated as the proportion of all possible weeks where Happy components are delivered at team level over the full season.; Reports of Happy program usage will be recorded electronically on a weekly basis by the head coach of each team using a web application. A full warm-up session includes 7 components. A full resistance exercise training includes 4 components. The coaches are encouraged to perform all Happy program components with their players twice a week.	Assessed weekly over 7 months
Other	Adherence duration of the the Happy warm-up components at team level	To gain a detailed understanding of the adherence to the warm-components included in the Happy program, an evaluation of for how long Happy warm-up components have been delivered at team level will be evaluated as the proportion of all possible weeks where Happy warm-up components are delivered at team level over the full season.; Reports of Happy program usage will be recorded electronically on a weekly basis by the head coach of each team using a web application. A full warm-up session includes 7 components. A full resistance exercise training includes 4 components. The coaches are encouraged to perform all Happy program components with their players twice a week.	Assessed weekly over 7 months
Other	Adherence duration of the Happy resistance training components at team level	To gain a detailed understanding of the adherence to the resistance training components included in the Happy program, an evaluation of for how long the Happy resistance training components have been delivered will be evaluated evaluated as the proportion of all possible weeks where Happy resistance training components are delivered at team level over the full season.; Reports of Happy program usage will be recorded electronically on a weekly basis by the head coach of each team using a web application. A full warm-up session includes 7 components. A full resistance exercise training includes 4 components. The coaches are encouraged to perform all Happy program components with their players twice a week.	Assessed weekly over 7 months
Other	Component fidelity at team level	The number of each Happy component completed of total number of each recommended over the season.	Assessed weekly over 7 months
Other	Adherence duration of the Happy resistance training components at player level	To support the evaluation at team level, an evaluation of for how long the Happy resistance training components has been completed will be evaluated at player level as the proportion of all possible weeks where Happy resistance training components are completed at player level over the full season.; Reports of Happy resistance training components usage will be recorded electronically on a weekly basis by the player using an application.	Assessed weekly over 7 months
Other	Adherence frequency at team level	How frequently the Happy components have been delivered (adherence frequency) will be evaluated as the average times per week Happy components were delivered at team level over the full season; Reports of Happy program usage will be recorded electronically on a weekly basis by the head coach of each team using a web application. A full warm-up session includes 7 components. A full resistance exercise training includes 4 components. The coaches are encouraged to perform all Happy program components with their players twice a week	Assessed weekly over 7 months
Other	Adherence frequency of the Happy warm-up components at team level	To gain a detailed understanding of the adherence to the warm-components included in the Happy program, an evaluation of how frequently the Happy warm-up components have been delivered will be evaluated as the average times per week Happy warm-up components were delivered at team level over the full season.; Reports of Happy program usage will be recorded electronically on a weekly basis by the head coach of each team using a web application. A full warm-up session includes 7 components. A full resistance exercise training includes 4 components. The coaches are encouraged to perform all Happy program components with their players twice a week.	Assessed weekly over 7 months
Other	Adherence frequency of the Happy resistance training components at team level	To gain a detailed understanding of the adherence to the resistance training components included in the Happy program, an evaluation of how frequently the Happy resistance training components have been delivered will be evaluated as the average times per week Happy resistance training components were delivered at team level over the full season.; Reports of Happy program usage will be recorded electronically on a weekly basis by the head coach of each team using a web application. A full warm-up session includes 7 components. A full resistance exercise training includes 4 components. The coaches are encouraged to perform all Happy program components with their players twice a week.	Assessed weekly over 7 months
Other	Adherence frequency of the Happy resistance training components at player level	To support the evaluation at team level, an evaluation of how frequently the Happy resistance training components has been completed will be evaluated at player level as the average times per week Happy resistance training components were completed at player level over the full season.; Reports of Happy resistance training components usage will be recorded electronically on a weekly basis by the player using an application.	Assessed weekly over 7 months
Primary	Adherence volume at team level	How much the Happy components have been delivered (adherence volume) will be evaluated as the number of Happy components delivered per week at team level over the full season; Reports of Happy program usage will be recorded electronically on a weekly basis by the head coach of each team using a web application. A full warm-up session includes 7 components. A full resistance exercise training includes 4 components. The coaches are encouraged to perform all Happy program components with their players twice a week	Measured weekly over 7 months
Primary	Shoulder, knee and ankle injuries using the Oslo Sports Trauma Research Center Health problems Questionnaire (OSTRC-H2)	The primary injury outcomes will be time to any new handball-related ankle, knee and shoulder injury defined as any tissue damage or other derangement of normal physical function due to participation in handball, resulting from rapid or repetitive transfer of kinetic energy, following a recent consensus statement from the International Olympic Committee; Injury status will be monitored weekly during the season using the Oslo Sports Trauma Research Center Overuse Injury Questionnaire distributed electronically to the players via an application. The questionnaire also measures exposure to handball, both training and match, during the last seven days.	Measured weekly over 7 months
Secondary	Adherence volume of the Happy warm-up components at team level	To gain a detailed understanding of the adherence to the warm-up components included in the Happy program, an evaluation of how much the Happy warm-up components have been delivered at team level will be evaluated as the number of Happy warm-up components delivered per week over the full season; Reports of Happy program usage will be recorded electronically on a weekly basis by the head coach of each team using a web application. A full warm-up session includes 7 components. A full resistance exercise training includes 4 components. The coaches are encouraged to perform all Happy program components with their players twice a week	Assessed weekly over 7 months
Secondary	Adherence volume of the Happy resistance training components at team level	To gain a detailed understanding of the adherence to the resistance training components included in the Happy program, an evaluation of how much the Happy resistance training components have been delivered at team level will be evaluated as the number of Happy resistance training components completed per week over the full season; Reports of Happy program usage will be recorded electronically on a weekly basis by the head coach of each team using a web application. A full warm-up session includes 7 components. A full resistance exercise training includes 4 components. The coaches are encouraged to perform all Happy program components with their players twice a week	Assessed weekly over 7 months
Secondary	Adherence volume of the Happy resistance training components at player level	To support the evaluation at team level, an evaluation of how much the Happy resistance training components has been completed will be evaluated at player level as the number of Happy resistance training components completed per week over the full season; Reports of Happy resistance training components usage will be recorded electronically on a weekly basis by the player using an application.	Assessed weekly over 7 months
Secondary	Substantial shoulder, knee and ankle injuries using the Oslo Sports Trauma Research Center Health problems Questionnaire (OSTRC-H2)	Secondary injury outcomes will be time to any substantial handball related ankle, knee and shoulder injury.; Injuries will be defined as any tissue damage or other derangement of normal physical function due to participation in handball, resulting from rapid or repetitive transfer of kinetic energy, following the 2020 consensus statement from the International Olympic Committee. Players reporting at least a moderate reduction in training volume or performance due to a health problem with the Oslo Sports Trauma Research Center Health Questionnaire and further classify the health problem as a new shoulder, knee or ankle injury is defined as an substantial injury.; Injury status will be monitored weekly during the season using the Oslo Sports Trauma Research Center Overuse Injury Questionnaire distributed electronically to the players via an application. The questionnaire also measures exposure to handball, both training and match, during the last seven days.	Assessed weekly over 7 months
Secondary	Health Action Process Approach (HAPA) Questionnaire responses	A questionnaire will be used to assess between-group differences in HAPA constructs (ie: intentions, outcome expectancies, self-efficacy, action planning and coping planning) between baseline and the mid-season and the end of playing season.	Will be assessed at baseline, mid-season (3 months after baseline) and at end season (7 months)
Secondary	Determinants of Implementation Behavior Questionnaire (DIBQ) responses	To support the Health Action Process Approach (HAPA) Questionnaire responses, The Determinants of Implementation Behavior Questionnaire (DIBQ) constructs focusing on social influences will be measured at baseline, at mid-season and at the end of the season. These questions will be added to the same questionnaire assessing the HAPA constructs.	Will be assessed at baseline, mid-season (3 months after baseline) and at end season (7 months)