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Focus of a Running Schedule and Risk of Running Injuries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02349373
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : February 6, 2018
University of Aarhus
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

Brief Summary:

Running is a natural part of human locomotion and humans have been running for million of years. In modern society, running has become a popular way of exercise and is undertaken by many people worldwide, possibly because it provides a cheap and easily accessible form of exercise, and the positive effects of running on health and fitness are well known. Unfortunately, running is also associated with a high risk of injury.

The purpose of this project is to investigate how a running schedule which focuses either on running distance or running speed influence the overall risk of injury and the types of injury sustained in recreational runners.

Condition or disease Intervention/treatment Phase
Running Related Injuries Behavioral: An 8 week preconditioning period Behavioral: 16 week training period Not Applicable

Detailed Description:
Trails directed at investigating differences in injury risk in relation to the focus of the running schedule have been conducted without any firm conclusions. People engaged in recreational running or choosing running as a new and active lifestyle needs guidance on which running schedules minimize the injury risk, aiding their chance of an active lifestyle and possibly reversing the increase in people developing a lifestyle disease. To develop running schedules minimizing the risk of injury, an understanding of the mechanisms that the different training variables impose on the human body is necessary. The existing literature on running intensity and the development of injuries show conflicting result. More studies are necessary to ascertain if there is a relationship between the intensity of running. In such studies, it is important to include other training variables in the analysis and to quantify running exposure using an objective method of measuring the relative intensity and absolute volume.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 839 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Focus of a Running Schedule and Its Association With the Risk of Running Injuries? A Randomized Trial.
Study Start Date : April 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : October 2017

Arm Intervention/treatment
Active Comparator: Preconditioning running
An 8 week preconditioning period. The variables of interest are running distance and running intensity: running speed >80% VO2max (maximal oxygen uptake).
Behavioral: An 8 week preconditioning period
Receipt of a weekly running schedule through an online training diary.

Active Comparator: Follow-up period

The Volume group progress 23% in total weekly running distance in the last adaptation week in the prior 4 week block.

The Intensity group progress 23% in weekly distance of running above 80% VO2 max (maximal oxygen uptake), based on the distance of running above 80% VO2max in the last adaptation week in the prior 4 week block.

Behavioral: 16 week training period
Receipt of a weekly running schedule through an online training diary.

Primary Outcome Measures :
  1. Running Related Injury (RRI) [ Time Frame: 24 weeks ]
    An injury will be reported through the online training diary. If the runners are injured an appointment for clinical examination is made with the diagnostic staff.

Secondary Outcome Measures :
  1. Symptoms of overuse injury [ Time Frame: 24 weeks ]
    A physical problem perceived as pain, tenderness, stiffness, aching, looseness and instability in any part of the body.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • on average 1-3 weekly running sessions the past 6 months
  • owns a pair of running shoes
  • internet access and mail address
  • owns a Garmin GPS watch (pulse rate watch) or an IPhone/Android phone

Exclusion Criteria:

  • previous injury in lower extremity within the past 6 months
  • unable to follow the running regime in 6 consecutive months
  • do not want to use GPS (Global Positioning System) watch or Android/Smart phone to register training
  • unable to read or understand Danish
  • deprecated by personal GP (General Practitioner) to run due to former surgery or physical disease
  • mental condition that does not allow participation (e.g. externalizing behaviors, dementia)
  • pregnancy
  • participants with blood pressure above normal according to WHO guidelines will need to consult own GP (General Practitioner) for approval

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02349373

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Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
University of Aarhus
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Study Chair: Sten Rasmussen, M.D. Aalborg University Hospital
Principal Investigator: Daniel R. Joergensen, PhD student University of Aarhus
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Northern Orthopaedic Division, Denmark Identifier: NCT02349373    
Other Study ID Numbers: N-20140069
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Keywords provided by Northern Orthopaedic Division, Denmark:
Overuse injury
Running related injury
Running pattern
Additional relevant MeSH terms:
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Wounds and Injuries