search
Back to results

Effectiveness of Injury Prevention Guidelines in Recreational Runners

Primary Purpose

Sports Injury

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Exercise program
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sports Injury focused on measuring Running-related injury

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male and female recreational runners with an average weekly running distance of at least 15km.

Exclusion Criteria:

  • Injury to the lower extremities during the past 6 months.

Sites / Locations

  • Cenrte for Health and Performance

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention INT

Arm Description

Normal training, no intervention

The intervention consists of an exercise program developed by a team specialised in orthopaedics, physiotherapy and biomechanics, based on the results from a recent prospective study in Gothenburg, Sweden. The exercises included cover muscle control training for the core, abductors, quadriceps and foot pronators, as well as foamrolling for the abductors, quadriceps, hamstrings, calf muscles and gluteal muscles. The runners will be instructed to perform the training program twice a week for the entire intervention period.

Outcomes

Primary Outcome Measures

Injury occurence
Incidence of running-related injuries

Secondary Outcome Measures

Full Information

First Posted
November 16, 2018
Last Updated
May 11, 2021
Sponsor
Sahlgrenska University Hospital, Sweden
search

1. Study Identification

Unique Protocol Identification Number
NCT03751150
Brief Title
Effectiveness of Injury Prevention Guidelines in Recreational Runners
Official Title
Effectiveness of Injury Prevention Guidelines in Recreational Runners
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 31, 2018 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
January 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this trial is to investigate the effectiveness of specific training programs on the incidence of injuries in recreational runners. 408 runners between the ages of 18 and 55 years, will be recruited and randomly allocated to either the intervention group or control group. The intervention group will perform the training program twice a week in addition to their regular training. Injury data will be collected as the injuries occur and documentation of injury will follow a predetermined definition of injury. Participants will submit weekly reports of their running distance, frequency, running-related pain, as well as successful performance of the assigned training program for the intervention groups. The primary outcome is the incidence of injuries in all groups.
Detailed Description
Injuries and especially overuse injuries within recreational running are a common occurrence with higher incidence rates in novice runners but also in recreational runners training for a specific event. The mechanisms behind overuse injury development are thought to be multifactorial and certain parameters have shown to increase injury risk in recreational runners. The aim of this trial is to target these specific parameters and implement training programs to which recreational runners will adhere for a period of 18 weeks. About 408 male and female recreational runners, aged 18-55 years will be randomly allocated to one either the intervention (INT) or Control (CON).The INT group will perform an exercise program containing muscle control and foamrolling exercises in addition to their regular training, twice a week. The CON group will continue as per usual with their training. Training data will be collected on a weekly basis from all groups and pain and injury information will be submitted by the participants upon occurrence. The primary outcome measure is the number of sustained injuries in both groups. Participants will be recruited in December 2018 and the intervention will start in January 2019 for a period of 18 weeks, ending in May 2019. Data analyses are anticipated to be completed in September 2019.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sports Injury
Keywords
Running-related injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Normal training, no intervention
Arm Title
Intervention INT
Arm Type
Experimental
Arm Description
The intervention consists of an exercise program developed by a team specialised in orthopaedics, physiotherapy and biomechanics, based on the results from a recent prospective study in Gothenburg, Sweden. The exercises included cover muscle control training for the core, abductors, quadriceps and foot pronators, as well as foamrolling for the abductors, quadriceps, hamstrings, calf muscles and gluteal muscles. The runners will be instructed to perform the training program twice a week for the entire intervention period.
Intervention Type
Other
Intervention Name(s)
Exercise program
Intervention Description
The runners will be asked to perform the training program twice a week. The intervention consist of muscle control and foam rolling exercises for the lower extremities.
Primary Outcome Measure Information:
Title
Injury occurence
Description
Incidence of running-related injuries
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male and female recreational runners with an average weekly running distance of at least 15km. Exclusion Criteria: Injury to the lower extremities during the past 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jòn Karlsson, Prof
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stefan Grau, Prof
Organizational Affiliation
Göteborg University
Official's Role
Study Director
Facility Information:
Facility Name
Cenrte for Health and Performance
City
Gothenburg
ZIP/Postal Code
41140
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Injury Prevention Guidelines in Recreational Runners

We'll reach out to this number within 24 hrs