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Focus of a Running Schedule and Risk of Running Injuries

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ClinicalTrials.gov Identifier: NCT02349373
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

Tracking Information
First Submitted Date  ICMJE January 23, 2015
First Posted Date  ICMJE January 28, 2015
Last Update Posted Date February 6, 2018
Study Start Date  ICMJE April 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Focus of a Running Schedule and Risk of Running Injuries
Official Title  ICMJE The Focus of a Running Schedule and Its Association With the Risk of Running Injuries? A Randomized Trial.
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Running Related Injuries
Intervention  ICMJE
  • Behavioral: An 8 week preconditioning period
    Receipt of a weekly running schedule through an online training diary.
  • Behavioral: 16 week training period
    Receipt of a weekly running schedule through an online training diary.
Study Arms  ICMJE
  • 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).
    Intervention: Behavioral: An 8 week preconditioning period
  • 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.

    Intervention: Behavioral: 16 week training period
Publications * Ramskov D, Nielsen RO, Sørensen H, Parner E, Lind M, Rasmussen S. The design of the run Clever randomized trial: running volume, -intensity and running-related injuries. BMC Musculoskelet Disord. 2016 Apr 23;17:177. doi: 10.1186/s12891-016-1020-0.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2016)
839
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2015)
4366
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02349373
Other Study ID Numbers  ICMJE N-20140069
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Northern Orthopaedic Division, Denmark
Study Sponsor  ICMJE Northern Orthopaedic Division, Denmark
Collaborators  ICMJE University of Aarhus
Investigators  ICMJE
Study Chair: Sten Rasmussen, M.D. Aalborg University Hospital
Principal Investigator: Daniel R. Joergensen, PhD student University of Aarhus
PRS Account Northern Orthopaedic Division, Denmark
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP