Adherence, Sports Injury Prevention ExercisesNCT05294237
Injury Prevention in Danish Youth Handball
A study testing Happy program and Support in people with Adherence, Sports Injury Prevention Exercises and Athletic Injuries, run by University of Southern Denmark at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adherence, Sports Injury Prevention Exercises, Athletic Injuries
- What is being tested?
- Happy program and Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 950 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Jun 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Injury Prevention in Danish Youth Handball - a Hybrid Effectiveness-implementation Study
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).
- Being tested
- Happy program, Support
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Happy programBehavioural
The Happy program consists of handball specific warm-up components and resistance training components and will be available online.
SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Supported Implementation (Intervention) | Experimental | 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. Receives: Behavioral: Happy program; Behavioral: Support |
| Unsupported implementation (control) | Active comparator | Access to the Happy program will be available online to the coaches. No additional education or support will be provided. Receives: Behavioral: Happy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured weekly over 7 months
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: Measured weekly over 7 months
Secondary outcomes (6)
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
Measured: Assessed weekly over 7 months
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
Measured: Assessed weekly over 7 months
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.
Measured: Assessed weekly over 7 months
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.
Measured: Assessed weekly over 7 months
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.
Measured: Will be assessed at baseline, mid-season (3 months after baseline) and at end season (7 months)
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.
Measured: Will be assessed at baseline, mid-season (3 months after baseline) and at end season (7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start21 Jun 2021
- Primary completion15 May 2022
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adherence, Sports Injury Prevention ExercisesStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 950 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Handball Federation
- Responsible party
- Sponsor
- Investigators
- Merete Møller, PhD, Principal investigator, University of Southern Denmark, Department of Sports Science and Biomechanics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294237
- Sponsor's protocol ID
- SDU-2021-57-(2089)
- Status last verified
- Jun 2022
- First submitted
- 24 Jun 2021
- Last updated
- 27 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moller M, Nygaard Andersen L, Moller S, Kongsted A, Juhl CB, Roos EM. Health And Performance Promotion in Youth (HAPPY) hybrid effectiveness-implementation cluster randomised trial: comparison of two strategies to implement an injury prevention exercise programme in Danish youth handball. Br J Sports Med. 2024 Oct 22;58(20):1205-1214. doi: 10.1136/bjsports-2023-107880.
PubMed 39209524
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injury Prevention in Danish Youth Handball - a Hybrid Effectiveness-implementation Study
- ClinicalTrials.gov ID
- NCT05294237
- Acronym / sponsor ID
- SDU-2021-57-(2089)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 950 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Danish Handball Federation
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supported Implementation (Intervention) | Experimental | Behavioral: Happy program, Behavioral: SupportThe 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. |
| Unsupported implementation (control) | Active comparator | Behavioral: Happy programAccess to the Happy program will be available online to the coaches. No additional education or support will be provided. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Happy programThe Happy program consists of handball specific warm-up components and resistance training components and will be available online. | Behavioural | Supported Implementation (Intervention), Unsupported implementation (control) |
| SupportThe support consists of a coach workshop at the beginning of the season and the opportunity for additional support for the coaches throughout the season. | Behavioural | Supported Implementation (Intervention) |
Primary outcome
Adherence volume at team level
Time frame: Measured weekly over 7 months
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)
Time frame: Measured weekly over 7 months
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.
6 secondary outcomes
Adherence volume of the Happy warm-up components at team level
Time frame: Assessed weekly over 7 months
Adherence volume of the Happy resistance training components at team level
Time frame: Assessed weekly over 7 months
Adherence volume of the Happy resistance training components at player level
Time frame: Assessed weekly over 7 months
Substantial shoulder, knee and ankle injuries using the Oslo Sports Trauma Research Center Health problems Questionnaire (OSTRC-H2)
Time frame: Assessed weekly over 7 months
Health Action Process Approach (HAPA) Questionnaire responses
Time frame: Will be assessed at baseline, mid-season (3 months after baseline) and at end season (7 months)
Determinants of Implementation Behavior Questionnaire (DIBQ) responses
Time frame: Will be assessed at baseline, mid-season (3 months after baseline) and at end season (7 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Derived from this study: PubMed 39209524Moller M, Nygaard Andersen L, Moller S, Kongsted A, Juhl CB, Roos EM. Health And Performance Promotion in Youth (HAPPY) hybrid effectiveness-implementation cluster randomised trial: comparison of two strategies to implement an injury prevention exercise programme in Danish youth handball. Br J Sports Med. 2024 Oct 22;58(20):1205-1214. doi: 10.1136/bjsports-2023-107880.
- Individual participant dataSharing planned: No
Related trials for Adherence, Sports Injury Prevention Exercises
Recruiting
Enhancing Prevention of Injuries in Community Youth and Adult Amateur Football Players
Injury Prevention in Sports, Adherence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Møller, PhD principal investigator
University of Southern Denmark, Department of Sports Science and Biomechanics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Happy program and Support in people with Adherence, Sports Injury Prevention Exercises and Athletic Injuries, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence volume at team level (time frame: Measured weekly over 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05294237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.