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Injury Prevention in Danish Youth Handball

Primary Purpose

Adherence, Sports Injury Prevention Exercises, Athletic Injuries

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Happy program
Support
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adherence, Sports Injury Prevention Exercises

Eligibility Criteria

11 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • University of Southern Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Supported Implementation (Intervention)

Unsupported implementation (control)

Arm Description

The Happy-program will be available online on a webpage and consists of 7 warm-up components and 4 resistance training components that can be completed after handball practice. The warm-up program has three exercise variations for each of the seven components. The coaches may deliver the four resistance training components in the field or in the gym. The resistance training components in the field and the gym targets the same four body areas but differs in that the components in the gym are performed with equipment, while the components in the field can be performed without equipment. Each resistance training component has three levels. Happy ambassadors (Health professionals with a handball player or coach background) will conduct a 3-hour train-the trainer workshop in the beginning of the season and provide coaches with the opportunity for support throughout the season. At mid-season, the ambassadors will re-visit the clubs for 1,5-hour supervision and support.

Access to the Happy program will be available online to the coaches. No additional education or support will be provided.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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
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
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.
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.
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.
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.

Full Information

First Posted
June 24, 2021
Last Updated
June 20, 2022
Sponsor
University of Southern Denmark
Collaborators
Danish Handball Federation
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1. Study Identification

Unique Protocol Identification Number
NCT05294237
Brief Title
Injury Prevention in Danish Youth Handball
Official Title
Injury Prevention in Danish Youth Handball - a Hybrid Effectiveness-implementation Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Denmark
Collaborators
Danish Handball Federation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adherence, Sports Injury Prevention Exercises, Athletic Injuries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
The clubs will be randomly assigned to either the control or intervention group at a 1:1 allocation ratio, using a computer-generated randomisation schedule. The randomisation will be performed by a person not else involved in the trial.
Allocation
Randomized
Enrollment
950 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supported Implementation (Intervention)
Arm Type
Experimental
Arm Description
The Happy-program will be available online on a webpage and consists of 7 warm-up components and 4 resistance training components that can be completed after handball practice. The warm-up program has three exercise variations for each of the seven components. The coaches may deliver the four resistance training components in the field or in the gym. The resistance training components in the field and the gym targets the same four body areas but differs in that the components in the gym are performed with equipment, while the components in the field can be performed without equipment. Each resistance training component has three levels. Happy ambassadors (Health professionals with a handball player or coach background) will conduct a 3-hour train-the trainer workshop in the beginning of the season and provide coaches with the opportunity for support throughout the season. At mid-season, the ambassadors will re-visit the clubs for 1,5-hour supervision and support.
Arm Title
Unsupported implementation (control)
Arm Type
Active Comparator
Arm Description
Access to the Happy program will be available online to the coaches. No additional education or support will be provided.
Intervention Type
Behavioral
Intervention Name(s)
Happy program
Intervention Description
The Happy program consists of handball specific warm-up components and resistance training components and will be available online.
Intervention Type
Behavioral
Intervention Name(s)
Support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence volume at team level
Description
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
Time Frame
Measured weekly over 7 months
Title
Shoulder, knee and ankle injuries using the Oslo Sports Trauma Research Center Health problems Questionnaire (OSTRC-H2)
Description
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.
Time Frame
Measured weekly over 7 months
Secondary Outcome Measure Information:
Title
Adherence volume of the Happy warm-up components at team level
Description
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
Time Frame
Assessed weekly over 7 months
Title
Adherence volume of the Happy resistance training components at team level
Description
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
Time Frame
Assessed weekly over 7 months
Title
Adherence volume of the Happy resistance training components at player level
Description
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.
Time Frame
Assessed weekly over 7 months
Title
Substantial shoulder, knee and ankle injuries using the Oslo Sports Trauma Research Center Health problems Questionnaire (OSTRC-H2)
Description
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.
Time Frame
Assessed weekly over 7 months
Title
Health Action Process Approach (HAPA) Questionnaire responses
Description
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.
Time Frame
Will be assessed at baseline, mid-season (3 months after baseline) and at end season (7 months)
Title
Determinants of Implementation Behavior Questionnaire (DIBQ) responses
Description
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.
Time Frame
Will be assessed at baseline, mid-season (3 months after baseline) and at end season (7 months)
Other Pre-specified Outcome Measures:
Title
Training volume
Description
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.
Time Frame
Assessed weekly over 7 months
Title
Match volume
Description
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.
Time Frame
Assessed weekly over 7 months
Title
Illness outcomes using the Oslo Sports Trauma Research Center Health problems Questionnaire (OSTRC-H2)
Description
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.
Time Frame
Assessed weekly over 7 months
Title
Injury outcomes using the Oslo Sports Trauma Research Center Health problems Questionnaire (OSTRC-H2)
Description
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.
Time Frame
Assessed weekly over 7 months
Title
Adherence duration at team level
Description
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.
Time Frame
Assessed weekly over 7 months
Title
Adherence duration of the the Happy warm-up components at team level
Description
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.
Time Frame
Assessed weekly over 7 months
Title
Adherence duration of the Happy resistance training components at team level
Description
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.
Time Frame
Assessed weekly over 7 months
Title
Component fidelity at team level
Description
The number of each Happy component completed of total number of each recommended over the season.
Time Frame
Assessed weekly over 7 months
Title
Adherence duration of the Happy resistance training components at player level
Description
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.
Time Frame
Assessed weekly over 7 months
Title
Adherence frequency at team level
Description
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
Time Frame
Assessed weekly over 7 months
Title
Adherence frequency of the Happy warm-up components at team level
Description
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.
Time Frame
Assessed weekly over 7 months
Title
Adherence frequency of the Happy resistance training components at team level
Description
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.
Time Frame
Assessed weekly over 7 months
Title
Adherence frequency of the Happy resistance training components at player level
Description
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.
Time Frame
Assessed weekly over 7 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Female, male, non-binary, prefer not to answer, other
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete Møller, PhD
Organizational Affiliation
University of Southern Denmark, Department of Sports Science and Biomechanics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern Denmark
City
Odense
State/Province
Southern Denmark
ZIP/Postal Code
5230
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Injury Prevention in Danish Youth Handball

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