Overuse InjuriesNCT01979562
Knowledge of Predicting Increased Risk for an Overuse Injury in Runners
An observational study of Overuse Injuries and Musculoskeletal Make-up in the Lower Extremities, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to examine the skeleton of the legs and the running style in order to predict a possible overuse injury. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overuse Injuries, Musculoskeletal Make-up in the Lower Extremities
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Jun 2015
- How long will I take part?
- 1 Year
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: 100 male runners from athletic associations in Northern Jutland.
Who may be able to join
- Men between 18 and 60 years
- Access to an e-mail
- Two years running experience as a minimum
- Exercises three times weekly as a minimum, on annual average or until any excessive load on the body occurs
- Experience with running machines
- A written signed statement of consent
Who cannot join
- Lack of a written signed statement of consent
- Unwillingness to keep a journal during the running exercises
- Unwillingness to register data during the follow-up period
- Injury in the lower extremities within 3 months before baseline
- The runner uses insoles or he has been through a surgical procedure in the lower extremities
- A mental disability for example dementia or challenging behaviour
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- The runner plays heavy sport, cf. American College of Sports Medicine
- Unability to read or understand Danish
- Unability to cooperate
Trial locations and contacts
1 site in 1 country.
Rene B. Korsgaard, M.Sc. contact
Denmark1 site, 1 recruiting
- Recruiting
Orthopaedic Surgery Research Unit, Aalborg University Hospital
Aalborg, Northern Jutland, 9000
Rene B. Korsgaard, M.Sc., rkb@hst.aau.dk
Sten Rasmussen, M.D., 25520462 ext. 45, sten.rasmussen@rn.dk
About this study
Official title: Knowledge of Predicting Increased Risk for an Overuse Injury in Runners Related to the Mutual Length of Femur and Tibia and the Running Style
The purpose of this study is to examine the skeleton of the legs and the running style in order to predict a possible overuse injury.
Read the detailed description
The running style and the training composition and the body composition are thought to have major effect on the development of overuse injuries.
To define a prevention strategy, one must have the knowledge about risk factors and causation. The training composition is very relevant clinically but the underlying factors have not been studied yet. For the present there is no scientifical evidence of a possible relation between the body composition such as the mutual length and width of femur and tibia and the development of overuse injuries.
Thus, the aim of this study is to achieve evidence-based knowledge of these factors in order to advice runners about the precautions and to avoid that people get a sedentary lifestyle.
- Keywords
- Overuse injury, Femur, Tibia, Running, Prevention
- Medical subject headings
- Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 100 runners | Male runners between 18-60 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury defined as inappropriate musculoskeletal make-up in the lower extremities
Measured: 1 year
Secondary outcomes (2)
Number of kilometres spent on running each week
Measured: 1 year
Bone contact forces on the distal tibia during the stance phase of running
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startMar 2014
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overuse InjuriesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rene B. Korsgaard, M.Sc., Principal investigator, Aalborg UniversitySten Rasmussen, M.D., Study director, Orthopaedic Research Unit, Aalborg University Hospital, DenmarkMichael Voigt, Prof., PhD, Study chair, Center for Motor-Sensory Interaction, Aalborg UniversityUwe Kersting, Ass.prof., Study chair, Aalborg UniversityRasmus O. Nielsen, M.Sc., Study chair, University of AarhusUffe Læssoe, Ass. prof., Study chair, University College, Northern Jutland, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979562
- Sponsor's protocol ID
- N-20130074
- Status last verified
- May 2015
- First submitted
- 4 Nov 2013
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge of Predicting Increased Risk for an Overuse Injury in Runners Related to the Mutual Length of Femur and Tibia and the Running Style
- ClinicalTrials.gov ID
- NCT01979562
- Acronym / sponsor ID
- N-20130074
- Keywords
- Overuse injury, Femur, Tibia, Running, Prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 8 Nov 2013 (estimated)
- 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.
The purpose of this study is to examine the skeleton of the legs and the running style in order to predict a possible overuse injury.
Detailed description
The running style and the training composition and the body composition are thought to have major effect on the development of overuse injuries.
To define a prevention strategy, one must have the knowledge about risk factors and causation. The training composition is very relevant clinically but the underlying factors have not been studied yet. For the present there is no scientifical evidence of a possible relation between the body composition such as the mutual length and width of femur and tibia and the development of overuse injuries.
Thus, the aim of this study is to achieve evidence-based knowledge of these factors in order to advice runners about the precautions and to avoid that people get a sedentary lifestyle.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 100 runners | – | –Male runners between 18-60 years. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 100 male runners from athletic associations in Northern Jutland.
Key inclusion criteria (6 listed)
- Men between 18 and 60 years
- Access to an e-mail
- Two years running experience as a minimum
- Exercises three times weekly as a minimum, on annual average or until any excessive load on the body occurs
- Experience with running machines
Key exclusion criteria (9 listed)
- Lack of a written signed statement of consent
- Unwillingness to keep a journal during the running exercises
- Unwillingness to register data during the follow-up period
- Injury in the lower extremities within 3 months before baseline
- The runner uses insoles or he has been through a surgical procedure in the lower extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Injury defined as inappropriate musculoskeletal make-up in the lower extremities
Time frame: 1 year
2 secondary outcomes
Number of kilometres spent on running each week
Time frame: 1 year
Bone contact forces on the distal tibia during the stance phase of running
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
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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.
Rene B. Korsgaard, M.Sc. contact
Rene B. Korsgaard, M.Sc. principal investigator
Aalborg University
Sten Rasmussen, M.D. study director
Orthopaedic Research Unit, Aalborg University Hospital, Denmark
Michael Voigt, Prof., PhD study chair
Center for Motor-Sensory Interaction, Aalborg University
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 Overuse Injuries and Musculoskeletal Make-up in the Lower Extremities, run by Northern Orthopaedic Division, Denmark 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 May 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rene B. Korsgaard, M.Sc. (rkb@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injury defined as inappropriate musculoskeletal make-up in the lower extremities (time frame: 1 year). 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 29 May 2015.