Sports InjuryNCT03751150
Effectiveness of Injury Prevention Guidelines in Recreational Runners
A study testing Exercise program in people with Sports Injury, run by Sahlgrenska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Injury
- What is being tested?
- Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 31 Dec 2018to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female recreational runners with an average weekly running distance of at least 15km.
Who cannot join
- Injury to the lower extremities during the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sports Injury
- Being tested
- Exercise program
- Keywords
- Running-related injury
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Normal training, no intervention |
| Intervention INT | Experimental | 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. Receives: Other: Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury occurence
Incidence of running-related injuries
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start31 Dec 2018
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports InjuryStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia Desai, Sahlgrenska University Hospital
- Investigators
- Jòn Karlsson, Prof, Study chair, Sahlgrenska University HospitalStefan Grau, Prof, Study director, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751150
- Sponsor's protocol ID
- SahgrenskaUH
- Status last verified
- May 2021
- First submitted
- 16 Nov 2018
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Injury Prevention Guidelines in Recreational Runners
- ClinicalTrials.gov ID
- NCT03751150
- Acronym / sponsor ID
- SahgrenskaUH
- Conditions
- Sports Injury
- Keywords
- Running-related injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Normal training, no intervention |
| Intervention INT | Experimental | Other: Exercise programThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and female recreational runners with an average weekly running distance of at least 15km.
Key exclusion criteria (1 listed)
- Injury to the lower extremities during the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise programThe 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. | Other | Intervention INT |
Primary outcome
Injury occurence
Time frame: 18 weeks
Incidence of running-related injuries
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jòn Karlsson, Prof study chair
Sahlgrenska University Hospital
Stefan Grau, Prof study director
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program in people with Sports Injury, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injury occurence (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.