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The Relation Between Running Patterns and Overuse Injuries in Runners

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ClinicalTrials.gov Identifier: NCT01063673
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : April 10, 2015
Sponsor:
Collaborators:
University of Aarhus
Bispebjerg Hospital
Foot and Ankle Research Northern Denmark
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

Tracking Information
First Submitted Date February 4, 2010
First Posted Date February 5, 2010
Last Update Posted Date April 10, 2015
Study Start Date June 2010
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 4, 2010)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01063673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Relation Between Running Patterns and Overuse Injuries in Runners
Official Title 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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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.
Condition Overuse Injuries
Intervention Not Provided
Study Groups/Cohorts Active runners
Observational follow-up study on 39 runners
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 22, 2011)
940
Original Actual Enrollment
 (submitted: February 4, 2010)
39
Actual Study Completion Date August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01063673
Other Study ID Numbers M-20110114
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Northern Orthopaedic Division, Denmark
Study Sponsor Northern Orthopaedic Division, Denmark
Collaborators
  • University of Aarhus
  • Bispebjerg Hospital
  • Foot and Ankle Research Northern Denmark
Investigators
Principal Investigator: Sten Rasmussen, M.D., DrMSc Orthopaedic Division, North Denmark Region, Aalborg Hospital - Aarhus University Hospital, Denmark
PRS Account Northern Orthopaedic Division, Denmark
Verification Date April 2015