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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03751150
Other study ID # SahgrenskaUH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 31, 2018
Est. completion date January 30, 2021

Study information

Verified date May 2021
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date January 30, 2021
Est. primary completion date January 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise program
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.

Locations

Country Name City State
Sweden Cenrte for Health and Performance Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Injury occurence Incidence of running-related injuries 18 weeks
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