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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02349373
Other study ID # N-20140069
Secondary ID
Status Completed
Phase N/A
First received January 23, 2015
Last updated February 5, 2018
Start date April 2015
Est. completion date October 2017

Study information

Verified date February 2018
Source Northern Orthopaedic Division, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 839
Est. completion date October 2017
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
An 8 week preconditioning period
Receipt of a weekly running schedule through an online training diary.
16 week training period
Receipt of a weekly running schedule through an online training diary.

Locations

Country Name City State
Denmark Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital Aalborg

Sponsors (2)

Lead Sponsor Collaborator
Northern Orthopaedic Division, Denmark University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Running Related Injury (RRI) 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. 24 weeks
Secondary Symptoms of overuse injury A physical problem perceived as pain, tenderness, stiffness, aching, looseness and instability in any part of the body. 24 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04743713 - Turkish Cross-cultural Adaptation, Validation and the Reliability of UWRI (University of Wisconsin Running Injury and Recovery Index)