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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01063673
Other study ID # M-20110114
Secondary ID
Status Completed
Phase N/A
First received February 4, 2010
Last updated April 9, 2015
Start date June 2010
Est. completion date August 2014

Study information

Verified date April 2015
Source Northern Orthopaedic Division, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Observational

Clinical 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.


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 RRIĀ“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.


Recruitment information / eligibility

Status Completed
Enrollment 940
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Northern Orthopaedic Division, Aalborg University Hospital Aalborg Northern Jutland
Denmark VIA UC Holstebro

Sponsors (4)

Lead Sponsor Collaborator
Northern Orthopaedic Division, Denmark Bispebjerg Hospital, Foot and Ankle Research Northern Denmark, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Injury defined as any musculoskeletal complaint of the lower extremity or back causing a restriction of running for at least 1 week. a two-week period before the injury arises No
See also
  Status Clinical Trial Phase
Recruiting NCT02106715 - Overuse Injuries in Road Cyclists, Prevalence and Prevention N/A
Recruiting NCT01979562 - Knowledge of Predicting Increased Risk for an Overuse Injury in Runners N/A