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Sports InjuryNCT03459313

Prevention of Injuries in Young Athletics (Track and Field) Athletes

A study testing Active group in people with Sports Injury, run by Linkoeping University at 1 site in Sweden.

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 long-term purpose of an on-going participatory action research program "The KLUB-study" in Sweden, that involves scientists and representatives from all levels of athletics, is to develop a sustainable framework for safe athletics (track and field) training for child athletes born 2002-2006. Read more about this study

Who is it for?
Ages 12 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Sports Injury
What is being tested?
Active group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteSweden
Study dates
18 Mar 2018to 1 Feb 2019
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 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • belonging to a sports club and participate in organized training, athletics (track and field)
  • born 2002 - 2006

Who cannot join

  • not, on a regular basis, participating in athletics (track and field) training

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Swedish Athletics

    Stockholm

Other trials in Sweden

About this study

Official title: Prevention of Injuries in Young Athletics (Track and Field) Athletes: Initiation of Life-long Sports Health Literacy - KLUB§ Athletics

The long-term purpose of an on-going participatory action research program "The KLUB-study" in Sweden, that involves scientists and representatives from all levels of athletics, is to develop a sustainable framework for safe athletics (track and field) training for child athletes born 2002-2006. The first part of the research program, a 1-year longitudinal study analysing training and injury data, was completed in November 2017. The present study sets out to evaluate a website that aims to support coaches and caregivers in their role as adult key stakeholders to foster young athletes to become adult athletes who possess the tools to maintain a healthy sporting lifestyle.

Read the detailed description

The intervention will be implemented in youth athletics and evaluated in a randomised controlled trial (RCT). It will follow the consensus guidelines for studies in athletics and be reported according to the CONSORT checklist. The participating clubs will be randomly allocated into active and control group. The active group will be provided the intervention program, i.e. access to a website, aimed to support coaches, caregivers´ and athletes' and improve knowledge and health literacy to make more informed choices that promote health. The control group will continue to train according to their routines and will get access to the website after 4 months.

The participants will be assessed at three times, at the beginning of the study (T1), after four months (T2), at ten months (T3) and additional prospective data on training and injury will be collected during the first four months (T1b).

Conditions
Sports Injury
Being tested
Active group
Medical subject headings
Athletic Injuries

What participants receive

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

  • Active groupOther

    For this study, the Frisk.Friidrott (Healthy.Athletics/Track\&Field) website has been developed. The purpose of the website is to provide an easy-to-use tool that can assist coaches and parents involved in youth athletics with information how to structure training and recovery planning, provide guidance on possible injuries, and provide other information on health for youth athletes.

Study groups in NCT03459313
Study groupRoleWhat they receive
Active groupExperimentalThe active group will be provided the intervention program, i.e. access to a website.
Receives: Other: Active group
Control groupNo interventionThe control group will continue to train according to their routines and will get access to the website after 4 months.

What is being measured

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

  1. Injury incidence

    The primary outcome measure will be time from study entry to the first reported injury event

    Measured: four months

Secondary outcomes (1)

  1. Health literacy

    Evaluate health literacy using Swedish versions of; The Japanese Communicative and Critical Health literacy scale (adults) and the Health Literacy for School-aged Children (HLSAC) instrument (youth athletes)

    Measured: four and ten months

Timeline

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

  1. First posted8 Mar 2018
  2. Study start18 Mar 2018
  3. Primary completion20 Jul 2018
  4. Study completion1 Feb 2019

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
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03459313
Sponsor's protocol ID
2017/520-31
Status last verified
Sep 2019
First submitted
23 Feb 2018
Last updated
1 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jacobsson J, Timpka T, Ekberg J, Kowalski J, Nilsson S, Renstrom P. Design of a protocol for large-scale epidemiological studies in individual sports: the Swedish Athletics injury study. Br J Sports Med. 2010 Dec;44(15):1106-11. doi: 10.1136/bjsm.2009.067678. Epub 2010 May 19.

    PubMed 20484318

  • Jacobsson J, Bergin D, Timpka T, Nyce JM, Dahlstrom O. Injuries in youth track and field are perceived to have multiple-level causes that call for ecological (holistic-developmental) interventions: A national sporting community perceptions and experiences. Scand J Med Sci Sports. 2018 Jan;28(1):348-355. doi: 10.1111/sms.12929. Epub 2017 Aug 4.

    PubMed 28605065

  • Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.

    PubMed 22036893

  • Timpka T, Alonso JM, Jacobsson J, Junge A, Branco P, Clarsen B, Kowalski J, Mountjoy M, Nilsson S, Pluim B, Renstrom P, Ronsen O, Steffen K, Edouard P. Injury and illness definitions and data collection procedures for use in epidemiological studies in Athletics (track and field): consensus statement. Br J Sports Med. 2014 Apr;48(7):483-90. doi: 10.1136/bjsports-2013-093241.

    PubMed 24620036

  • Jacobsson J, Kowalski J, Timpka T, Hansson PO, Spreco A, Dahlstrom O. Universal prevention through a digital health platform reduces injury incidence in youth athletics (track and field): a cluster randomised controlled trial. Br J Sports Med. 2023 Mar;57(6):364-370. doi: 10.1136/bjsports-2021-105332. Epub 2022 Dec 23.

    PubMed 36564148

Questions about this trial

What is this clinical trial studying?

A study testing Active group in people with Sports Injury, run by Linkoeping University at 1 site in Sweden.

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: finished, as of the sponsor's last update on 1 Oct 2019. 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 Sweden. 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?

Injury incidence (time frame: four months). 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 NCT03459313, which also lists 5 linked publications.

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 1 Oct 2019.

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