Running Related Injury Among Novice Runners

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Northern Orthopaedic Division, Denmark
Sponsor:
Collaborator:
Department of Public Health, Aarhus University
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT02014987
First received: December 9, 2013
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Training Errors
Overuse Injury
Behavioral: Training programmes
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Initial Running Volume and Running Related Injury Among Novice Runners

Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Running related injury [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 160
Study Start Date: July 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Running training programmes

Runners with a high body mass index are going to follow a training programme of 3 kilometres per week compared to a training programme of 6 kilometres per week.

The amount of running will be increased with 10 % per week.

Behavioral: Training programmes

Runners with a high body mass index follow two types of training programmes:

  1. a running programme of 3 kilometres per week
  2. a running programme 6 kilometres per week

The amount of running will be increased with 10 % per week.


Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02014987

Contacts
Contact: Sten Rasmussen, MD sten.rasmussen@rn.dk
Contact: Michael L. Bertelsen, PT

Locations
Denmark
Sten Rasmussen Recruiting
Aalborg, Northern Jutland, Denmark, 9000
Contact: Sten Rasmussen, MD       sten.rasmussen@rn.dk   
Contact: Michael Bertelsen, PT       miclejber@gmail.com   
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Department of Public Health, Aarhus University
Investigators
Study Chair: Michael L. Bertelsen, PT Department of Publich Health, Aarhus University
Principal Investigator: Sten Rasmussen, MD Orthopaedic Research Unit, Aalborg University Hospital, Denmark
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT02014987     History of Changes
Other Study ID Numbers: N-20130035
Study First Received: December 9, 2013
Last Updated: March 28, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Running related injury
Overuse injury
Running pattern

Additional relevant MeSH terms:
Cumulative Trauma Disorders
Wounds and Injuries
Sprains and Strains

ClinicalTrials.gov processed this record on July 22, 2014