The Relation Between Running Patterns and Overuse Injuries in Runners
| Tracking Information | |||||
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| First Received Date ICMJE | February 4, 2010 | ||||
| Last Updated Date | May 1, 2013 | ||||
| Start Date ICMJE | June 2010 | ||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01063673 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Relation Between Running Patterns and Overuse Injuries in Runners | ||||
| Official Title ICMJE | The Relation Between Running Patterns and Overuse Injuries in Runners | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| 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. |
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| Condition ICMJE | Overuse Injuries | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Active runners
Observational follow-up study on 39 runners |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 940 | ||||
| Estimated Completion Date | June 2014 | ||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01063673 | ||||
| Other Study ID Numbers ICMJE | N-20110114 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Northern Orthopaedic Division, Denmark | ||||
| Study Sponsor ICMJE | Northern Orthopaedic Division, Denmark | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Northern Orthopaedic Division, Denmark | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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