NCT02349373

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
839

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

January 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

January 23, 2015

Last Update Submit

February 5, 2018

Conditions

Running Related Injuries

Keywords

Overuse injuryRunning related injuryRunning pattern

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Symptoms of overuse injury

    24 weeks

Study Arms (2)

Preconditioning running

ACTIVE COMPARATOR

An 8 week preconditioning period. The variables of interest are running distance and running intensity: running speed \>80% VO2max (maximal oxygen uptake).

Behavioral: An 8 week preconditioning period

Follow-up period

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.

Behavioral: 16 week training period

Interventions

An 8 week preconditioning periodBEHAVIORAL

Receipt of a weekly running schedule through an online training diary.

Preconditioning running
16 week training periodBEHAVIORAL

Receipt of a weekly running schedule through an online training diary.

Follow-up period

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Related Publications (1)

  • Ramskov D, Nielsen RO, Sorensen H, Parner E, Lind M, Rasmussen S. The design of the run Clever randomized trial: running volume, -intensity and running-related injuries. BMC Musculoskelet Disord. 2016 Apr 23;17:177. doi: 10.1186/s12891-016-1020-0.

    PMID: 27107810DERIVED

MeSH Terms

Conditions

Cumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Sprains and StrainsWounds and Injuries

Study Officials

  • Sten Rasmussen, M.D.

    Aalborg University Hospital

    STUDY CHAIR

  • Daniel R. Joergensen, PhD student

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2015

First Posted

January 28, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2016

Study Completion

October 1, 2017

Last Updated

February 6, 2018

Record last verified: 2018-02

Locations

DK(1)