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Focus of a Running Schedule and Risk of Running Injuries

Primary Purpose

Running Related Injuries

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
An 8 week preconditioning period
16 week training period
Sponsored by
Northern Orthopaedic Division, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Running Related Injuries focused on measuring Overuse injury, Running related injury, Running pattern

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Preconditioning running

Follow-up period

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Symptoms of overuse injury
A physical problem perceived as pain, tenderness, stiffness, aching, looseness and instability in any part of the body.

Full Information

First Posted
January 23, 2015
Last Updated
February 5, 2018
Sponsor
Northern Orthopaedic Division, Denmark
Collaborators
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02349373
Brief Title
Focus of a Running Schedule and Risk of Running Injuries
Official Title
The Focus of a Running Schedule and Its Association With the Risk of Running Injuries? A Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Orthopaedic Division, Denmark
Collaborators
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Running Related Injuries
Keywords
Overuse injury, Running related injury, Running pattern

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
839 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preconditioning running
Arm Type
Active Comparator
Arm Description
An 8 week preconditioning period. The variables of interest are running distance and running intensity: running speed >80% VO2max (maximal oxygen uptake).
Arm Title
Follow-up period
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
An 8 week preconditioning period
Intervention Description
Receipt of a weekly running schedule through an online training diary.
Intervention Type
Behavioral
Intervention Name(s)
16 week training period
Intervention Description
Receipt of a weekly running schedule through an online training diary.
Primary Outcome Measure Information:
Title
Running Related Injury (RRI)
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Symptoms of overuse injury
Description
A physical problem perceived as pain, tenderness, stiffness, aching, looseness and instability in any part of the body.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sten Rasmussen, M.D.
Organizational Affiliation
Aalborg University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Daniel R. Joergensen, PhD student
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
27107810
Citation
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.
Results Reference
derived

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Focus of a Running Schedule and Risk of Running Injuries

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