NCT01063673

Brief Summary

Running patterns are thought to have a major influence on the development of Running Related Injuries (RRI), however to studies have documented such relationship. Thus, the aim of the study is to investigate the association between running patterns and overuse injuries in runners.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
940

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

4.2 years

First QC Date

February 4, 2010

Last Update Submit

April 9, 2015

Conditions

Keywords

Running, overuse injury, limits humans

Outcome Measures

Primary Outcomes (1)

  • Injury defined as any musculoskeletal complaint of the lower extremity or back causing a restriction of running for at least 1 week.

    a two-week period before the injury arises

Study Arms (1)

Active runners

Observational follow-up study on 39 runners

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Beginners: n = 1000. By means of the Danish Personal Register adult citizens (age 18-65 years) from Aarhus Municipality are identified, contacted by phone, and invited to participate in the study. A question on running experience in the past is used to assess the novelty to running. 500 beginners with previous running experience and 500 beginners without previous running experience (former runners) will be included in the study. It is estimated that 11000 persons have to be contracted to include 1000 individuals. Healthy persons who have not sustained an injury in the lower extremity in the last 3 months before inclusion and who have not been running for the last 12 months, are eligible for the study. Participants are excluded if there are absolute contraindications for vigorous physical activities according to the ACSM, or in case of unwillingness to keep a training log / wear a heart rate belt during training.

You may qualify if:

  • between 18 and 65 years old
  • has a GPS-watch that can measure training data (Garmin Forerunner 205,305 or 405)
  • has an e-mail address

You may not qualify if:

  • does not wish to keep a training diary
  • has not registered training data in the follow-up period
  • has had an injury in the leg within the last three months before baseline
  • active with another tough sports, cf. American College of Sports Medicine
  • psychic condition that does not allow participation
  • cannot read or understand Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northern Orthopaedic Division, Aalborg University Hospital

Aalborg, Northern Jutland, 9000, Denmark

Location

VIA UC

Holstebro, 7500, Denmark

Location

MeSH Terms

Conditions

Cumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Sprains and StrainsWounds and Injuries

Study Officials

  • Sten Rasmussen, M.D., DrMSc

    Orthopaedic Division, North Denmark Region, Aalborg Hospital - Aarhus University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2010

First Posted

February 5, 2010

Study Start

June 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations