Running Related Injury Among Novice Runners

Overuse Injury Clinical Trial

Official title:

The Initial Running Volume and Running Related Injury Among Novice Runners

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02014987
• Other study ID #: N-20130035
• Status: Recruiting
• Phase: Phase 0
• First received: December 9, 2013
• Last updated: April 9, 2015
• Start date: July 2013
• Est. completion date: January 2016

Study information

• Verified date: April 2015
• Source: Northern Orthopaedic Division, Denmark
• Contact: Sten Rasmussen, MD
• Email: sten.rasmussen[@]rn.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

About 31% of the Danish population participates regularly in running. The positive health benefits of running have been well documented in the literature. Unfortunately, running has been connected with a high risk of injuries.

Running related injuries can cause a long rehabilitation and may even force the runner to quit running permanently. To ensure that running can be practiced as a safe exercise activity prevention must be considered.

Description:

Training errors (i.e. excessive volume, sudden change of training routines etc.) are held to be the main reasons to running related injuries. Fortunately, training errors can be avoided as training characteristics (distance, duration, pace) can be controlled by the runner.

In order to avoiding training errors, especially excessive volume many novice runners follow 0-5 kilometres type training programmes. However, limited research has been conducted on the training volume of beginner programs and the risk of running related injuries.

The purpose of this study is to investigate the relationship between the running volume the first 4 weeks of a running regime and the risk of running related injuries among novice runners. The relationship between running volume and running related injuries will be investigated in proportion to their body mass index (BMI).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• both gender between 16-65 years

• no running-training within the last year

• less than 20 hours of sports activity within the last year (in total)

• internet access and mail address

• body mass index between 18.5 - 25 or 30-35

• owns a pair of running shoes

Exclusion Criteria:

• do not want to use a GPS watch

• unable or unwilling to follow the running regime in 4 consecutive weeks

• previous injury in lower extremity within the last 2 years

• unable to read or understand Danish

• former heart surgery

• known heart surgery

• known lung disease

• diabetes

• current pregnancy

• known tendency to shortness of breath or chest pain with activity

• known tendency to leg pain when walking long distances

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cumulative Trauma Disorders
• Overuse Injury
• Treatment Error

Intervention

Behavioral:
• Training programmes
Runners with a high body mass index follow two types of training programmes: a running programme of 3 kilometres per week a running programme 6 kilometres per week The amount of running will be increased with 10 % per week.

Locations

Country	Name	City	State
Denmark	Sten Rasmussen	Aalborg	Northern Jutland

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	An injury sustained on muscles, joints, tendons and/or bones during or after running. The injury must have caused a workout reduction (reduced distance, intensity, frequency etc.) for at least 7 days.	7 days	Yes