Overuse InjuriesNCT01063673
The Relation Between Running Patterns and Overuse Injuries in Runners
An observational study of Overuse Injuries, run by Northern Orthopaedic Division, Denmark at 2 sites in Denmark.
Trial summary
Running patterns are thought to have a major influence on the development of Running Related Injuries (RRI), however to studies have documented such relationship. Thus, the aim of the study is to investigate the association between running patterns and overuse injuries in runners. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overuse Injuries
- How many people
- 940 participants
- Where
- 2 sitesDenmark
- Study dates
- Jun 2010to Aug 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Beginners: n = 1000. By means of the Danish Personal Register adult citizens (age 18-65 years) from Aarhus Municipality are identified, contacted by phone, and invited to participate in the study. A question on running experience in the past is used to assess the novelty to running. 500 beginners with previous running experience and 500 beginners without previous running experience (former runners) will be included in the study. It is estimated that 11000 persons have to be contracted to include 1000 individuals. Healthy persons who have not sustained an injury in the lower extremity in the last 3 months before inclusion and who have not been running for the last 12 months, are eligible for the study. Participants are excluded if there are absolute contraindications for vigorous physical activities according to the ACSM, or in case of unwillingness to keep a training log / wear a heart rate belt during training.
Who may be able to join
- between 18 and 65 years old
- has a GPS-watch that can measure training data (Garmin Forerunner 205,305 or 405)
- has registered their training (if they have run) for a period of at least three months before the inclusion in the trial
- has an e-mail address
Who cannot join
- does not wish to keep a training diary
- has not registered training data in the follow-up period
- has had an injury in the leg within the last three months before baseline
- active with another tough sports, cf. American College of Sports Medicine
- psychic condition that does not allow participation
- cannot read or understand Danish
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Northern Orthopaedic Division, Aalborg University Hospital
Aalborg, Northern Jutland, 9000
VIA UC
Holstebro, 7500
About this study
Running patterns are thought to have a major influence on the development of Running Related Injuries (RRI), however to studies have documented such relationship. Thus, the aim of the study is to investigate the association between running patterns and overuse injuries in runners.
Read the detailed description
Running patterns are thought to have a major influence on the development of Running Related Injuries (RRI).
Worldwide, running is a sport practiced by many individuals to improve cardio-respiratory function, health and well-being. Although running positively contributes to health, there is also a risk of running related injuries (RRI). At best, the consequence of RRI´s is a periodic absence from physical activity, with the athlete returning to sport within weeks. In the worst case, the injury is a chronic painful condition, causing a sedentary lifestyle without physical activity. This is undesirable since physical inactivity increases the risk of lifestyle diseases and death.
In Denmark it is estimated that 4.500 deaths each year can be attributed directly to inactivity. Furthermore, inactivity leads to reduced quality of life compared to active persons. To avoid people getting a sedentary lifestyle prevention of RRI are necessary.
To define a prevention strategy, one must have knowledge about risk factors and causation. Many risk factors have been proposed. Among these, running patterns and foot type are thought to play a major role in the development of RRI. However, very few firm conclusions can be made based on the existing literature, often because of methodical problems. Consequently, it is suggested to design large scale prospective studies controlling for multiple variables. Furthermore, studies should differentiate between novice, elite and extreme runners. Thus, the study design in this project will take these suggestions into account.
The aim of the study is to investigate the association between running patterns and overuse injuries in runners.
- Conditions
- Overuse Injuries
- Keywords
- Running, overuse injury, limits humans
- 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 |
|---|---|---|
| Active runners | Observational follow-up study on 39 runners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury defined as any musculoskeletal complaint of the lower extremity or back causing a restriction of running for at least 1 week.
Measured: a two-week period before the injury arises
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2014
- Study completionAug 2014
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
- 940 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Bispebjerg Hospital, Foot and Ankle Research Northern Denmark
- Responsible party
- Sponsor
- Investigators
- Sten Rasmussen, M.D., DrMSc, Principal investigator, Orthopaedic Division, North Denmark Region, Aalborg Hospital - Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063673
- Sponsor's protocol ID
- M-20110114
- Status last verified
- Apr 2015
- First submitted
- 4 Feb 2010
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Running Patterns and Overuse Injuries in Runners
- ClinicalTrials.gov ID
- NCT01063673
- Acronym / sponsor ID
- M-20110114
- Conditions
- Overuse Injuries
- Keywords
- Running, overuse injury, limits humans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 940 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- University of Aarhus, Bispebjerg Hospital, Foot and Ankle Research Northern Denmark
- Study start
- Jun 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 5 Feb 2010 (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.
Running patterns are thought to have a major influence on the development of Running Related Injuries (RRI), however to studies have documented such relationship. Thus, the aim of the study is to investigate the association between running patterns and overuse injuries in runners.
Detailed description
Running patterns are thought to have a major influence on the development of Running Related Injuries (RRI).
Worldwide, running is a sport practiced by many individuals to improve cardio-respiratory function, health and well-being. Although running positively contributes to health, there is also a risk of running related injuries (RRI). At best, the consequence of RRI´s is a periodic absence from physical activity, with the athlete returning to sport within weeks. In the worst case, the injury is a chronic painful condition, causing a sedentary lifestyle without physical activity. This is undesirable since physical inactivity increases the risk of lifestyle diseases and death.
In Denmark it is estimated that 4.500 deaths each year can be attributed directly to inactivity. Furthermore, inactivity leads to reduced quality of life compared to active persons. To avoid people getting a sedentary lifestyle prevention of RRI are necessary.
To define a prevention strategy, one must have knowledge about risk factors and causation. Many risk factors have been proposed. Among these, running patterns and foot type are thought to play a major role in the development of RRI. However, very few firm conclusions can be made based on the existing literature, often because of methodical problems. Consequently, it is suggested to design large scale prospective studies controlling for multiple variables. Furthermore, studies should differentiate between novice, elite and extreme runners. Thus, the study design in this project will take these suggestions into account.
The aim of the study is to investigate the association between running patterns and overuse injuries in runners.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active runners | – | –Observational follow-up study on 39 runners |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Beginners: n = 1000. By means of the Danish Personal Register adult citizens (age 18-65 years) from Aarhus Municipality are identified, contacted by phone, and invited to participate in the study. A question on running experience in the past is used to assess the novelty to running. 500 beginners with previous running experience and 500 beginners without previous running experience (former runners) will be included in the study. It is estimated that 11000 persons have to be contracted to include 1000 individuals. Healthy persons who have not sustained an injury in the lower extremity in the last 3 months before inclusion and who have not been running for the last 12 months, are eligible for the study. Participants are excluded if there are absolute contraindications for vigorous physical activities according to the ACSM, or in case of unwillingness to keep a training log / wear a heart rate belt during training.
Key inclusion criteria (4 listed)
- between 18 and 65 years old
- has a GPS-watch that can measure training data (Garmin Forerunner 205,305 or 405)
- has registered their training (if they have run) for a period of at least three months before the inclusion in the trial
- has an e-mail address
Key exclusion criteria (6 listed)
- does not wish to keep a training diary
- has not registered training data in the follow-up period
- has had an injury in the leg within the last three months before baseline
- active with another tough sports, cf. American College of Sports Medicine
- psychic condition that does not allow participation
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 any musculoskeletal complaint of the lower extremity or back causing a restriction of running for at least 1 week.
Time frame: a two-week period before the injury arises
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 10 Apr 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.
Sten Rasmussen, M.D., DrMSc principal investigator
Orthopaedic Division, North Denmark Region, Aalborg Hospital - Aarhus University Hospital, Denmark
2 sites 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, run by Northern Orthopaedic Division, Denmark at 2 sites 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 4 inclusion and 6 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 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Injury defined as any musculoskeletal complaint of the lower extremity or back causing a restriction of running for at least 1 week. (time frame: a two-week period before the injury arises). 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 10 Apr 2015.