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临床试验/NCT04272047
NCT04272047已完成不适用

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

Linkoeping University1 个研究点 分布在 1 个国家目标入组 548 人开始时间: 2020年3月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
548
试验地点
1
主要终点
All physical complaints injury in four main locations

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Physiotherapists who assess injuries are blinded to group belonging. Statistician performing outcome analyses are blinded to group belonging.

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for randomized intervention arms A and B:
  • •Teams participating in youth or adult league series in the 2020 football season. All players in the eligible teams will be invited to participate (players from the age of 14 and older, born 2006 or earlier)
  • •Teams who have not used a structured training program aiming to prevent injuries that resembles the 3 intervention arms (e.g. the Knee Control program, Knee Control+ program, 11+ program, Adductor strengthening program) on a regular basis the last year
  • •Teams who have scheduled training at least twice per week
  • •Inclusion criteria for the non-randomized intervention arm C:
  • •Teams participating in youth or adult league series in the 2020 football season. All players in the eligible teams will be invited to participate (players from the age of 14 and older, born 2006 or earlier)
  • •Teams who have used the Knee Control program on a regular basis the last year, but no other structured training program aiming to prevent injuries (e.g. the Knee Control+ program, 11+ program, Adductor strengthening program)
  • •Teams who have scheduled training at least twice per week

排除标准

  • •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

研究组 & 干预措施

Knee Control+

Experimental

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 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.

干预措施: Knee Control+ program (Other)

Adductor strengthening program

Experimental

The 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.

干预措施: Adductor strengthening program (Other)

Knee Control

Active Comparator

Teams 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.

干预措施: Knee Control program (Other)

结局指标

主要结局

All physical complaints injury in four main locations

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

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)

次要结局

  • Adverse events(Study start up to end of season (7 months))
  • Player experience of injuries and intervention program(Three times during the season: at study start, at 4 months and at 7 months)
  • Coach experience of injuries and intervention program(Three times during the season: at study start, at 4 months and at 7 months)
  • All physical complaints injury(Study start up to end of season (7 months))
  • Medical attention injury(Study start up to end of season (7 months))
  • Time-loss injury(Study start up to end of season (7 months))
  • Acute or gradual onset injury(Study start up to end of season (7 months))
  • Substantial injury(Study start up to end of season (7 months))
  • Team intervention compliance(Study start up to end of season (7 months))
  • Player intervention compliance(Study start up to end of season (7 months))
  • Exercise fidelity(One observation during the season after approximately 6 months)
  • Health care need(Study start up to end of season (7 months))
  • Utilization fidelity(Two times during the season: at 4 months and 7 months)
  • Costs(Study start up to end of season (7 months))

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Martin Hägglund

Professor

Linkoeping University

研究点 (1)

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