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Sports InjuryNCT06486090

Effectiveness and Process Evaluation of the Injury-preventive Program #Utviklingsklar

A study testing #Utviklingsklar in people with Sports Injury, run by Norwegian School of Sport Sciences at 6 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The majority of injuries among Norwegian youth occur in sports. The purpose of the project is to conduct an effect and process evaluation of the intervention #Utviklingsklar, an injury-preventive club-based intervention in youth handball and football. Read more about this study

Who is it for?
Ages 12 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Sports Injury
What is being tested?
#Utviklingsklar
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,954 participants
Where
6 sitesNorway
Study dates
7 May 2024to 30 Nov 2025
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 12 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • -Clubs are eligible for participation if they are able to participate with one club leader, 2-6 teams, and a minimum of one coach from each of the participating teams

Who cannot join

  • Players under the age of 12
  • Coaches under the age of 16

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Norway6 sites

  • Hordaland Fotballkrets

    Bergen

  • Håndballregion Øst

    Oslo

  • Oslo Fotballkrets

    Oslo

  • Akershus Fotballkrets

    Strømmen

  • Håndballregion Nord

    Trondheim

  • Trøndelag Fotballkrets

    Trondheim

Other trials in Norway

About this study

The majority of injuries among Norwegian youth occur in sports. The purpose of the project is to conduct an effect and process evaluation of the intervention #Utviklingsklar, an injury-preventive club-based intervention in youth handball and football. Central to the evaluation is whether the intervention influences the occurrence of new and recurring injuries through changed coaching practices (injury prevention warm-up, strength training, and management of players with pain and injuries). Over one season, participants from 30 clubs in youth handball and football respectively will participate in two cluster-randomized studies. Coaches and club leaders implement #Utviklingsklar and create plans and practices for injury prevention. The control clubs train as usual. Players report injuries. An additional handball and football club are followed up with observation and interviews in a qualitative part of the process evaluation. The project provides knowledge about how injuries and health in the ¾ of Norwegian youth who participate in organized sports are affected by interventions aimed at club and coaching practices.

Conditions
Sports Injury
Being tested
#Utviklingsklar
Medical subject headings
Athletic Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • #UtviklingsklarBehavioural

    The intervention consists of 1) an e-learning course, 2) a workshop to create plans and practices for injury-prevention, 3) a mid-season meeting

Study groups in NCT06486090
Study groupRoleWhat they receive
#UtviklingsklarExperimentalThe intervention consists of 1) an e-learning course, 2) a workshop to create plans and practices for injury-prevention, 3) a mid-season meeting
Receives: Behavioral: #Utviklingsklar
ControlNo interventionPractice as usual, which may include other injury-preventive coaching practices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oslo Sports Trauma Research Center Questionnaire on Health Problems (OSTRC-H2)

    Weekly injury severity score (0 best - 100 worst)

    Measured: Average of biweekly reports over 1 sports season (estimated to 32 weeks)

Secondary outcomes (7)

  1. Sudden and gradual onset injuries

    Weekly injury severity score during the match season for sudden and gradual onset injuries

    Measured: 1 sports season (estimated to 32 weeks)

  2. Injury location

    Weekly injury severity score during the match season for lower leg, ankle/foot, knee, shoulder (handball), thigh (football), hip/groin (football), lumbosacral (football) and head (football) injuries

    Measured: 1 sports season (estimated to 32 weeks)

  3. Injury location for sudden onset injuries

    weekly injury severity score during the match season for sudden onset lower leg, ankle/foot, knee, shoulder (handball), thigh (football), hip/groin (football), and lumbosacral (football) injuries

    Measured: 1 sports season (estimated to 32 weeks)

  4. Injury location gradual onset injuries

    Weekly injury severity score during the match season for gradual-onset lower leg, ankle/foot, knee, shoulder (handball), thigh (football), hip/groin (football), and lumbosacral (football) injuries

    Measured: 1 sports season (estimated to 32 weeks)

  5. Injury burden

    Defined as the sum of injury severity score divided by the sum of exposure (per 1000 hours), where the sums are over team and over match season. The unit of analysis for burden is thus team and not player.

    Measured: 1 sports season (estimated to 32 weeks)

  6. Sports Injury Preventive Behavior Questionnaire (construct scores 0 worst - 1 best)

    The aggregated construct scores for the determinants 1) risk perception, 2) intention, 3) outcome expectancies, 4) action self-efficacy, 5) maintenance self-efficacy, 6) coping self-efficacy, 7) recovery self-efficacy, 8) action plans 9) coping plans and 10) club social support

    Measured: Baseline, midseason and post season (about 32 weeks)

  7. Injury-preventive coaching practices

    The injury-preventive coaching practice outcomes consist of:

    1. The change in the extent to which teams complete warm-up as described in the intervention from baseline to end-of season.
    2. The change in the extent to which teams complete strength training as described in the intervention from baseline to end-of season.
    3. The change in the extent to which players with pain or injuries receive guidance on medical care from baseline to end-of season.
    4. The change in the extent to which training and match participation is facilitated for players with pain or injuries from baseline to end-of season.

    Measured: Baseline and post season (about 32 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2024
  2. Study start7 May 2024
  3. Primary completion9 Nov 2025
  4. Study completion30 Nov 2025

Resources

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
Single blind
Who is masked
Investigator
Enrolment
2,954 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06486090
Sponsor's protocol ID
329-130324
Status last verified
Dec 2025
First submitted
9 May 2024
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing #Utviklingsklar in people with Sports Injury, run by Norwegian School of Sport Sciences at 6 sites in Norway.

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 1 inclusion and 2 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: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Norway. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Oslo Sports Trauma Research Center Questionnaire on Health Problems (OSTRC-H2) (time frame: Average of biweekly reports over 1 sports season (estimated to 32 weeks)). 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 NCT06486090.

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 17 Dec 2025.

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