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Running Related Injury Among Novice Runners

Primary Purpose

Treatment Error, Overuse Injury

Status
Unknown status
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Training programmes
Sponsored by
Northern Orthopaedic Division, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

  • Sten RasmussenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Running training programmes

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 9, 2013
Last Updated
April 9, 2015
Sponsor
Northern Orthopaedic Division, Denmark
Collaborators
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02014987
Brief Title
Running Related Injury Among Novice Runners
Official Title
The Initial Running Volume and Running Related Injury Among Novice Runners
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

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
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Error, Overuse Injury
Keywords
Running related injury, Overuse injury, Running pattern

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Running training programmes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Training programmes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Running related injury
Description
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.
Time Frame
7 days

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sten Rasmussen, MD
Email
sten.rasmussen@rn.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Michael L. Bertelsen, PT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L. Bertelsen, PT
Organizational Affiliation
Department of Publich Health, Aarhus University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sten Rasmussen, MD
Organizational Affiliation
Northern Orthopaedic Division, Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sten Rasmussen
City
Aalborg
State/Province
Northern Jutland
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sten Rasmussen, MD
Email
sten.rasmussen@rn.dk
First Name & Middle Initial & Last Name & Degree
Michael Bertelsen, PT
Email
miclejber@gmail.com

12. IPD Sharing Statement

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Running Related Injury Among Novice Runners

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