Sprint PerformanceNCT03306511
Sprint Performance in Football Players With a Previous Hamstring Injury
An observational study of Sprint Performance and Hamstring Injury, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men only
- Conditions the study is for
- Sprint Performance, Hamstring Injury
- What is being tested?
- Repeated-sprint test
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2017to 31 Dec 2017
- Phase
- Observational
- 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 18 to 35 years
- Men only
- No healthy volunteers
- Adult
Study population: Danish competitive football players
Who may be able to join
- Able to participate fully in regular football training and matches
- 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.
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Testing will be conducted in the facilities of the included football clubs in Copenhagen
Copenhagen, Danmark, 1904
About this study
Official title: Sprint Performance in Football Players With a Previous Hamstring Injury Compared to Healthy Controls: An Exploratory Cross-sectional Study
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.
Read more
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).
- Conditions
- Sprint Performance, Hamstring Injury
- Being tested
- Repeated-sprint test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated-sprint testOther
6x30-meter sprint interspersed with 90-s rest
| Study group | Role | What they receive |
|---|---|---|
| Case | Football players with a previous self-reported hamstring strain injury in the preceding 12 months Receives: Other: Repeated-sprint test | |
| Control | Football players without a previous self-reported hamstring strain injury in the preceding 12 months Receives: Other: Repeated-sprint test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Theoretical maximal force
Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.
Measured: Baseline
Theoretical maximal velocity
Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start1 Oct 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sprint PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lasse Ishøi, Hvidovre University Hospital
- Investigators
- Lasse Ishøi, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306511
- Sponsor's protocol ID
- SPRINT2017
- Status last verified
- Jun 2018
- First submitted
- 5 Oct 2017
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sprint Performance in Football Players With a Previous Hamstring Injury Compared to Healthy Controls: An Exploratory Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03306511
- Acronym / sponsor ID
- SPRINT2017
- Conditions
- Sprint Performance, Hamstring Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: Repeated-sprint testFootball players with a previous self-reported hamstring strain injury in the preceding 12 months |
| Control | – | Other: Repeated-sprint testFootball players without a previous self-reported hamstring strain injury in the preceding 12 months |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Danish competitive football players
Key inclusion criteria (3 listed)
- Able to participate fully in regular football training and matches
- 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.
Key exclusion criteria (5 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repeated-sprint test6x30-meter sprint interspersed with 90-s rest | Other | Case, Control |
Primary outcome
Theoretical maximal force
Time frame: Baseline
Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.
Theoretical maximal velocity
Time frame: Baseline
Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.
Theoritical maximal power output
Time frame: Baseline
Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.
Slope of the linear decrease on ratio of force as sprint velocity increases
Time frame: Baseline
Measured using the MySprint Application during a repeated-sprint test consisting of 6x30-m sprints. The outcome measure is exploratory.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lasse Ishøi principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sprint Performance and Hamstring Injury, run by Hvidovre University Hospital at 1 site in Denmark.
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 3 inclusion and 5 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 13 Jun 2018. 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 Denmark. 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?
Theoretical maximal force (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2018.