This trial is active, not recruiting.

Condition running related injuries
Treatments an 8 week preconditioning period, 16 week training period
Sponsor Northern Orthopaedic Division, Denmark
Collaborator University of Aarhus
Start date April 2015
End date March 2016
Trial size 839 participants
Trial identifier NCT02349373, N-20140069


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
(Active Comparator)
An 8 week preconditioning period. The variables of interest are running distance and running intensity: running speed >80% VO2max (maximal oxygen uptake).
an 8 week preconditioning period
Receipt of a weekly running schedule through an online training diary.
(Active Comparator)
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.
16 week training period
Receipt of a weekly running schedule through an online training diary.

Primary Outcomes

Running Related Injury (RRI)
time frame: 24 weeks

Secondary Outcomes

Symptoms of overuse injury
time frame: 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title The Focus of a Running Schedule and Its Association With the Risk of Running Injuries? A Randomized Trial.
Principal investigator Daniel R. Joergensen, PhD student
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Northern Orthopaedic Division, Denmark.