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Athletic InjuriesSWIPEsoccerNCT04272047

Prevention of Lower Limb and Groin Injuries: the Sport Without Injury ProgrammE (SWIPE) Football Trial

A study testing Adductor strengthening program in people with Athletic Injuries, 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

This is a three-armed intervention study that evaluates the injury preventive effects of three different training interventions in youth and adult football players. Two intervention arms are randomized and one arm acts as a non-randomized comparison group. Read more about this study

Who is it for?
Ages 14 years and olderHealthy volunteers can take part
Conditions the study is for
Athletic Injuries
What is being tested?
Adductor strengthening program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
548 participants
Where
1 siteSweden
Study dates
30 Mar 2020to 31 Dec 2020
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 14 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Teams who have used a structured groin injury prevention exercise program (e.g. Adductor strengthening program, Hölmich protocol) on a regular basis the last year

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Linköping University

    Linköping, 58183

Other trials in Sweden

About this study

This is a three-armed intervention study that evaluates the injury preventive effects of three different training interventions in youth and adult football players. Two intervention arms are randomized and one arm acts as a non-randomized comparison group. Half of randomized participants will receive a general injury prevention exercise program with emphasis on the lower extremities, and the other half a hip/groin focused injury prevention exercise. A third group of participants who already use an injury prevention exercise program at study inclusion are invited to participate as a non-randomized comparison group and continue their usual training practices.

Read the detailed description

The study is a cluster-randomized controlled trial including male and female youth and adult football players (≥14 years). Club is used as cluster unit, where all the teams from the same club will be randomized to the same intervention arm. The randomization is stratified by level (junior/senior) and sex (male/female).

The study has three intervention arms:

Teams in the randomized intervention group A receive education of the injury prevention exercise program Knee Control+ (Knäkontroll+) before the start of the competitive football season in April. Knee Control+ consists of 6 different exercises, with 10 different variations/progressions, and takes 10-15 minutes to complete. In addition, teams are instructed to perform a structured 5-minute running warm-up before the Knee Control+ exercises. Teams are to carry out the running warm-up and Knee Control+ at all training sessions, and the running warm-up before all matches, during the whole season.

Teams in the randomized intervention group B receive education of an Adductor strengthening program before the start of the competitive football season in April. The Adductor strengthening program consists of a single exercise with three levels of difficulty, as described by Harøy et al., 2019, British Journal of Sports Medicine. The exercise is based on the Copenhagen Adduction exercise. Teams are to carry out the Adductor strengthening program as part of their regular warm-up 2-3 times per week, one set per side, during the pre-season, and 1 time per week, one set per side during the in-season. One set takes about 5 minutes to complete for a pair of players.

Teams reporting that they are already using the injury prevention exercise program Knee Control (Knäkontroll) at recruitment are not eligible for inclusion in the randomization. They will be invited to participate in the study as a non-randomized intervention group C and act as a comparison group to the randomized groups A and B. These teams will carry on their normal training and warm-up routines with no intervention from the researchers. Knee Control consists of 6 different exercises, with 4 different variations/progressions and 1 pair-exercise.

Hypotheses:

Hypothesis 1: Teams/athletes in the randomized group A (Knee Control+) will have a lower rate of ankle, knee and hamstring injuries compared to teams/athletes in the randomized group B (Adductor strengthening program).

Hypothesis 2: Teams/athletes in the randomized group B (Adductor strengthening program) will have a lower rate of hip/groin injuries compared to teams/athletes in the randomized group A (Knee Control+).

Hypothesis 3: Teams/athletes in the randomized group A (Knee Control+) will have a higher intervention compliance compared to teams/athletes in the non-randomized comparison group (Knee Control).

Data collection:

Teams are followed for one competitive football season from April to October 2020. Data registered for the study include individual exposure to football training and matches, and injuries that occur as a result of participation in football. Exposure and injury data are athlete-reported prospectively every week using web-based questionnaires (the Oslo Sports Trauma Research Center questionnaire). Study designated physiotherapists will collect additional injury information for the four main injury outcomes via telephone interview using a standard injury card. Use of the intervention (compliance) is reported weekly by the team coach and the athletes. Coaches and players will report demographics at baseline, and at three time-points during the season (baseline, mid-season, end of season) will report use and experiences of the training interventions, injury risk perceptions and outcome expectancies.

Sample size for primary outcomes:

Hypothesis 1: required sample size for primary outcome "any football related injury occurring to the ankle, knee or hamstrings, regardless of need of care or absence from football training or matches" is 252 subjects (approximately 17 teams). To account for a 30% dropout a sample size of 328 subjects (approximately 22 teams) is planned at study start.

Hypothesis 2: required sample size for primary outcome "any football related injury occurring to the hip/groin, regardless of need of care or absence from football training or matches" is 301 subjects (approximately 20 teams). To account for a 30% dropout a sample size of 391 subjects (approximately 26 teams) is planned at study start.

Statistical analysis plan:

Generalised estimating equations will be used to analyse cluster-aggregated weekly data of injuries and exposure. A Poisson distribution with a log link function will be applied to calculate the rate ratio and corresponding 95% confidence intervals for the injury incidence and injury prevalence according to the intention to treat (ITT) principle. ITT analyses on a whole group level will be adjusted for sex, and analyses will also be performed by sex separately. The statistician who performs the ITT analysis will be blinded to group allocation. The number needed to treat will be calculated as the inverted absolute rate reduction for the primary outcomes.

Being tested
Knee Control+ program, Adductor strengthening program, Knee Control program
Keywords
Prevention
Medical subject headings
Athletic Injuries

What participants receive

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

  • Knee Control+ programOther

    15-20 minute training program to be performed at all team training sessions during the season.

  • Adductor strengthening programOther

    Adductor strengthening program to be performed 2-3 times per week, one set per side, during the pre-season, and 1 time per week, one set per side during the in-season.

  • Knee Control programOther

    15-20 minute training program to be performed as per the team's usual routines (no intervention from the researchers).

Study groups in NCT04272047
Study groupRoleWhat they receive
Knee Control+ExperimentalKnee Control+ consists of 6 different exercises, with 10 different variations/progressions, and takes 10-15 minutes to complete. In addition, teams are instructed to perform a 5-minute running warm-up before the Knee Control+ exercises. Teams are to carry out the running warm-up and Knee Control+ at all training sessions, and the running warm-up before all matches, during the whole season. Knee Control+ is based on the Knee Control program but with more variations for each exercise making it easier to tailor for the needs in the respective teams.
Receives: Other: Knee Control+ program
Adductor strengthening programExperimentalThe Adductor strengthening program consists of a single exercise with three levels of difficulty. The exercise is based on the Copenhagen Adduction exercise. Teams are to carry out the Adductor strengthening program as part of their regular warm-up 2-3 times per week, one set per side, during the pre-season, and 1 time per week, one set per side during the in-season.
Receives: Other: Adductor strengthening program
Knee ControlActive comparatorTeams will carry on their normal training and warm-up routines using the Knee Control program with no intervention from the researchers. Knee Control consists of 6 different exercises, with 4 different variations/progressions and 1 pair-exercise.
Receives: Other: Knee Control program

What is being measured

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

  1. All physical complaints injury in four main locations

    Any football related injury occurring to the ankle, knee, hamstrings and hip/groin, regardless of need of care or absence from football training or matches ("all physical complaints" injury definition)

    Measured: Study start up to end of season (7 months)

Secondary outcomes (14)
  1. All physical complaints injury

    Football related injury regardless of need of care or absence from football training or matches ("all physical complaints" injury definition)

    Measured: Study start up to end of season (7 months)

  2. Time-loss injury

    Football related injury causing absence from training or match with the team ("time-loss injury"). Time-loss injuries will be analyzed for all injury locations and for the four main injury locations (ankle, knee, hamstrings and hip/groin) separately.

    Measured: Study start up to end of season (7 months)

  3. Medical attention injury

    Football related injury where the player reports seeking care from a medical professional ("medical attention injury"). Medical attention injuries will be analyzed for all injury locations and for the four main injury locations (ankle, knee, hamstrings and hip/groin) separately.

    Measured: Study start up to end of season (7 months)

  4. Acute or gradual onset injury

    Football related injury that occurs suddenly and is associated with a specific, identifiable event ("acute injury") or injury with gradual onset caused by repeated microtrauma without a single, identifiable event responsible for the injury ("gradual onset injury"). Acute and gradual onset injuries will be analyzed for all injury locations and for the four main injury locations (ankle, knee, hamstrings and hip/groin) separately.

    Measured: Study start up to end of season (7 months)

  5. Substantial injury

    Football related injury leading to moderate or severe reductions in training volume or performance, or inability to participate in football according to the Oslo Sports Trauma Research Center questionnaire ("substantial injury"). Substantial injuries will be analyzed for all injury locations and for the four main injury locations (ankle, knee, hamstrings and hip/groin) separately.

    Measured: Study start up to end of season (7 months)

  6. Adverse events

    Adverse events of using the interventions.

    Measured: Study start up to end of season (7 months)

  7. Team intervention compliance

    Coach reported compliance with each respective intervention protocol. Coaches will report each week the number of team activities (trainings and matches) and the use of the intervention (yes/no) for each of these activities. Team intervention compliance will be calculated as a) the average weekly number of intervention sessions performed during the season, and b) as a proportion, i.e. the number of team intervention sessions / total number of team activities during the season. Team compliance will be reported separately for trainings and matches.

    Measured: Study start up to end of season (7 months)

  8. Player intervention compliance

    Player reported compliance with each respective intervention protocol. Players will report each week the number of activities (trainings and matches) they participated in and the use of the intervention (yes/no) for each of these activities. Player intervention compliance will be calculated as the average weekly number of intervention sessions performed during the season. Player compliance will be reported separately for trainings and matches.

    Measured: Study start up to end of season (7 months)

  9. Exercise fidelity

    Observation of a team training session by a study physiotherapist to evaluate exercise fidelity, i.e. performing exercises according to instructions. A standard checklist will be used in the observation of players performing the intervention exercises and each exercise will be marked as correct/incorrect. Exercise fidelity will be reported as a proportion: number of exercises performed correctly / total number of exercise observations.

    Measured: One observation during the season after approximately 6 months

  10. Utilization fidelity

    Coach reported utilization fidelity of the intervention. At mid-season (approximately 4 months) and at the end of the season (7 months) coaches will report the use of the intervention program in a survey describing which exercises were used, which progression/difficulty levels of the program were used, timing of the exercise use (before, beginning, during, or after the training session), and dosage (number of sets, number of repetitions or time per exercise). Utilization fidelity will be presented as a descriptive outcome.

    Measured: Two times during the season: at 4 months and 7 months

  11. Coach experience of injuries and intervention program

    Coach baseline, mid-season and follow-up experiences of injuries and of the interventions. Coaches will answer a survey with likert scale questions (rank 1-7) about risk perceptions of sport participation, perceived effects of the intervention, and experiences of using the intervention program. The outcome will be reported as median values of the likert scale questions (1-7).

    Measured: Three times during the season: at study start, at 4 months and at 7 months

  12. Player experience of injuries and intervention program

    Player baseline, mid-season and follow-up experiences of injuries and of the interventions. Players will answer a survey with likert scale questions (rank 1-7) about risk perceptions of sport participation, perceived effects of the intervention, and experiences of using the intervention program. The outcome will be reported as median values of the likert scale questions (1-7).

    Measured: Three times during the season: at study start, at 4 months and at 7 months

  13. Health care need

    Number of health care visits due to football related injuries during the season, type of diagnostic examinations and treatments

    Measured: Study start up to end of season (7 months)

  14. Costs

    Estimated costs of football related injuries and costs of the intervention

    Measured: Study start up to end of season (7 months)

Timeline

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

  1. First posted17 Feb 2020
  2. Study start30 Mar 2020
  3. Primary completion30 Nov 2020
  4. Study completion31 Dec 2020

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
Model description
This is a three-armed intervention study that evaluates the injury preventive effects of three different training interventions in youth and adult football players. Two intervention arms are randomized and one arm acts as a non-randomized comparison group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
548 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04272047
Sponsor's protocol ID
2019-06462
Other IDs
2019
Acronym
SWIPEsoccer
Status last verified
Apr 2022
First submitted
10 Feb 2020
Last updated
7 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data may be available upon reasonable request to the principal investigator

Publications

  • Lindblom H, Akerlund I, Walden M, Sonesson S, Hagglund M. Players are positive regarding injury prevention exercise programmes, but coaches need ongoing support: a survey-based evaluation using the Health Action Process Approach model across one season in amateur and youth football. BMJ Open Sport Exerc Med. 2024 Jun 24;10(2):e002009. doi: 10.1136/bmjsem-2024-002009. eCollection 2024.

    PubMed 38933370
  • Sonesson S, Lindblom H, Hagglund M. Higher age and present injury at the start of the season are risk factors for in-season injury in amateur male and female football players-a prospective cohort study. Knee Surg Sports Traumatol Arthrosc. 2023 Oct;31(10):4618-4630. doi: 10.1007/s00167-023-07517-6. Epub 2023 Aug 5.

    PubMed 37542529
  • Lindblom H, Walden M, Hagglund M. Adherence to Injury Prevention Exercise Programmes in Amateur Adolescent and Adult Football: A Detailed Description of Programme Use from a Randomised Study. Sports Med Open. 2023 Jul 15;9(1):57. doi: 10.1186/s40798-023-00608-1.

    PubMed 37452894
  • Lindblom H, Sonesson S, Torvaldsson K, Walden M, Hagglund M. Extended Knee Control programme lowers weekly hamstring, knee and ankle injury prevalence compared with an adductor strength programme or self-selected injury prevention exercises in adolescent and adult amateur football players: a two-armed cluster-randomised trial with an additional comparison arm. Br J Sports Med. 2023 Jan;57(2):83-90. doi: 10.1136/bjsports-2022-105890. Epub 2022 Oct 31.

    PubMed 36316115

Questions about this trial

What is this clinical trial studying?

A study testing Adductor strengthening program in people with Athletic Injuries, 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 0 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 7 Apr 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 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?

All physical complaints injury in four main locations (time frame: Study start up to end of season (7 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 NCT04272047, which also lists 4 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 7 Apr 2022.

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