NCT03306511

Brief Summary

Few studies indicate that sprint performance may be impaired in football players with a previous hamstring strain injury. This exploratory cross-sectional study aim to compare sprint performance between football players with and without a previous hamstring strain injury. The findings may elucidate potential indications of insufficient rehabilitation following a hamstring strain injury. Sprint performance data will be collected using the MySprint Iphone Application. Due to pragmatic reasons and the exploratory nature of this study the aim is to include players on a team level. Based on the prevalence of hamstring strain injuries the expected number of cases to be included are 10-20 football players with a previous hamstring strain injury, and a corresponding 80-90 number of healthy controls. No outcomes will be weighted (flat outcome structure).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

June 13, 2018

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

October 5, 2017

Last Update Submit

June 12, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • Theoretical maximal force

    Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.

    Baseline

  • Theoretical maximal velocity

    Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.

    Baseline

  • Theoritical maximal power output

    Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.

    Baseline

  • Slope of the linear decrease on ratio of force as sprint velocity increases

    Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.

    Baseline

Study Arms (2)

Case

Football players with a previous self-reported hamstring strain injury in the preceding 12 months

Other: Repeated-sprint test

Control

Football players without a previous self-reported hamstring strain injury in the preceding 12 months

Other: Repeated-sprint test

Interventions

6x30-meter sprint interspersed with 90-s rest

CaseControl

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Danish competitive football players

You may qualify if:

  • Able to participate fully in regular football training and matches

You may not qualify if:

  • Self-reported hamstring strain injury resulting in loss of regular football training sessions or football matches in the preceding 12 months.
  • Longstanding injury (\>6 weeks) in the lower extremities or trunk in the preceding 12 months.
  • Any pain in the lower extremity, pelvis, or spine during testing
  • Able to participate fully in regular football training and matches
  • Self-reported hamstring strain injury resulting in loss of regular football training sessions or football matches in the preceding 12 months.
  • Longstanding injury (\>6 weeks) in the lower extremities (except hamstring strain injury) or trunk in the preceding 12 months.
  • Any pain in the lower extremity, pelvis, or spine during testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Testing will be conducted in the facilities of the included football clubs in Copenhagen

Copenhagen, Danmark, 1904, Denmark

Location

Study Officials

  • Lasse Ishøi

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

October 5, 2017

First Posted

October 11, 2017

Study Start

October 1, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

June 13, 2018

Record last verified: 2018-06

Locations