Lower Extremity InjuryNCT03408925
Preventing Injury in Elite Orienteerers
A study testing Exercise program in people with Lower Extremity Injury, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of this study is to investigate the effect a specific exercise program on the incidence of injuries in the lower extremity. 72 elite orienteerers, aged 18-40 years, are allocated to an intervention or control group. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Lower Extremity Injury
- What is being tested?
- Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSweden
- Study dates
- 27 Feb 2018to 15 Oct 2018
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult elite orienteerers Aged 18-40 years Participating in the highest national orienteering league (Swedish League) Participant inclusion criteria - Age group: Adult Participant inclusion criteria - Gender: Both
Who cannot join
- Injured adult elite orienteerers not able to perform baseline tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Lower Extremity Injury in Elite Orienteerers
The aim of this study is to investigate the effect a specific exercise program on the incidence of injuries in the lower extremity. 72 elite orienteerers, aged 18-40 years, are allocated to an intervention or control group. The intervention group performs four specific exercises, four times a week (10 minutes per session) in conjunction with normal training. Injury data are collected every second week using valid injury questionnaire distributed by text messages over 14 weeks. Primary outcome is number of substantial injuries in the lower extremity. Secondary outcomes are incidence of ankle sprains and the average substantial injury prevalence across the 10 weeks.
Read the detailed description
The high physical load associated with running through uneven terrain contributes to that orienteerers are exposed to high injury risk, where the majority of injuries located in the lower extremities. Specific training programmes have been effective at reducing injury risk in sports. Yet, not trial has been conducted in elite orienteering. The aim of this study is to investigate the effect a specific exercise program on the incidence of injuries in the lower extremity. 72 elite orienteerers, aged 18-40 years, are allocated to an intervention or control group. The intervention group performs four specific exercises, with three difficult levels intensified every second week over the first four weeks, targeting strength, flexibility and coordination of the lower extremity. The exercises are completed four times a week (10 minutes per session) in conjunction with normal training. Injury data are collected every second week using valid injury questionnaire distributed by text messages over 14 weeks. Primary outcome is number of substantial injuries in the lower extremity. Secondary outcomes are incidence of ankle sprains and the average substantial injury prevalence across the 10 weeks. Participants will be recruited in January-February 2018. The intervention starts in February 2018 and data collection will be completed in June 2018. Data analyses are expected to be completed in October-November 2018.
Due to high injury risk and lack of injury prevention trials in orienteering, a RCT investigating the effect of a specific exercise program on the incidence of injuries in the lower extremity, is warranted. The results of this trial will be beneficial to orienteerers, clubs, federations and increase our understanding on how lower extremity injuries can be prevented in a physically challenging sport.
- Conditions
- Lower Extremity Injury
- Being tested
- Exercise program
- Keywords
- elite orienteering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
The orienteerers are asked to perform specific exercises four times a week throughout the entire study period. The exercises are heel rises, runners pose, single leg stance and one-leg jumps with three difficult levels aiming to mainly improve lower extremity strength and neuromuscular function. Each second week the exercises' difficulty level is increased.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention consists of an exercise program developed by the medical team of the National Federation of Orienteering. Specifically, it consists of four exercises targeting strength, flexibility and coordination of the lower extremity. The orienteerers are asked to perform the exercises four times a week throughout the entire study period. The exercises are heel rises, runners pose, single leg stance and one-leg jumps with three difficult levels aiming to mainly improve lower extremity strength and neuromuscular function (online supplement). Each second week the exercises' difficulty level is increased. Receives: Other: Exercise program |
| Control | No intervention | Normal training, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity injury
Number of substantial injuries in the lower extremity
Measured: March-June 2018 (10 weeks)
Secondary outcomes (2)
Ankle sprain
Incidence of ankle sprains injuries
Measured: March-June 2018 (10 weeks)
Substantial injury
The average substantial injury prevalence
Measured: March-June 2018 (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start27 Feb 2018
- Primary completion20 Jun 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity InjuryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Model description
- RCT, two groups (intervention/control)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip von Rosen, Karolinska Institutet
- Investigators
- Philip von Rosen, Study chair, Karolinska Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408925
- Sponsor's protocol ID
- 4-1645/2017
- Status last verified
- Feb 2020
- First submitted
- 16 Jan 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
von Rosen P, Halvarsson B. Preventing lower extremity injury in elite orienteerers: study protocol for a randomised controlled trial. BMJ Open Sport Exerc Med. 2018 Apr 20;4(1):e000347. doi: 10.1136/bmjsem-2018-000347. eCollection 2018.
PubMed 29707231
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Lower Extremity Injury in Elite Orienteerers
- ClinicalTrials.gov ID
- NCT03408925
- Acronym / sponsor ID
- 4-1645/2017
- Conditions
- Lower Extremity Injury
- Keywords
- elite orienteering
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 24 Jan 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 study is to investigate the effect a specific exercise program on the incidence of injuries in the lower extremity. 72 elite orienteerers, aged 18-40 years, are allocated to an intervention or control group. The intervention group performs four specific exercises, four times a week (10 minutes per session) in conjunction with normal training. Injury data are collected every second week using valid injury questionnaire distributed by text messages over 14 weeks. Primary outcome is number of substantial injuries in the lower extremity. Secondary outcomes are incidence of ankle sprains and the average substantial injury prevalence across the 10 weeks.
Detailed description
The high physical load associated with running through uneven terrain contributes to that orienteerers are exposed to high injury risk, where the majority of injuries located in the lower extremities. Specific training programmes have been effective at reducing injury risk in sports. Yet, not trial has been conducted in elite orienteering. The aim of this study is to investigate the effect a specific exercise program on the incidence of injuries in the lower extremity. 72 elite orienteerers, aged 18-40 years, are allocated to an intervention or control group. The intervention group performs four specific exercises, with three difficult levels intensified every second week over the first four weeks, targeting strength, flexibility and coordination of the lower extremity. The exercises are completed four times a week (10 minutes per session) in conjunction with normal training. Injury data are collected every second week using valid injury questionnaire distributed by text messages over 14 weeks. Primary outcome is number of substantial injuries in the lower extremity. Secondary outcomes are incidence of ankle sprains and the average substantial injury prevalence across the 10 weeks. Participants will be recruited in January-February 2018. The intervention starts in February 2018 and data collection will be completed in June 2018. Data analyses are expected to be completed in October-November 2018.
Due to high injury risk and lack of injury prevention trials in orienteering, a RCT investigating the effect of a specific exercise program on the incidence of injuries in the lower extremity, is warranted. The results of this trial will be beneficial to orienteerers, clubs, federations and increase our understanding on how lower extremity injuries can be prevented in a physically challenging sport.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT, two groups (intervention/control)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Exercise programThe intervention consists of an exercise program developed by the medical team of the National Federation of Orienteering. Specifically, it consists of four exercises targeting strength, flexibility and coordination of the lower extremity. The orienteerers are asked to perform the exercises four times a week throughout the entire study period. The exercises are heel rises, runners pose, single leg stance and one-leg jumps with three difficult levels aiming to mainly improve lower extremity strength and neuromuscular function (online supplement). Each second week the exercises' difficulty level is increased. |
| Control | No intervention | –Normal training, no intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult elite orienteerers Aged 18-40 years Participating in the highest national orienteering league (Swedish League) Participant inclusion criteria - Age group: Adult Participant inclusion criteria - Gender: Both
Key exclusion criteria (1 listed)
- Injured adult elite orienteerers not able to perform baseline tests
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 orienteerers are asked to perform specific exercises four times a week throughout the entire study period. The exercises are heel rises, runners pose, single leg stance and one-leg jumps with three difficult levels aiming to mainly improve lower extremity strength and neuromuscular function. Each second week the exercises' difficulty level is increased. | Other | Intervention |
Primary outcome
Lower extremity injury
Time frame: March-June 2018 (10 weeks)
Number of substantial injuries in the lower extremity
2 secondary outcomes
Ankle sprain
Time frame: March-June 2018 (10 weeks)
Substantial injury
Time frame: March-June 2018 (10 weeks)
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 20 Feb 2020.
- Derived from this study: PubMed 29707231von Rosen P, Halvarsson B. Preventing lower extremity injury in elite orienteerers: study protocol for a randomised controlled trial. BMJ Open Sport Exerc Med. 2018 Apr 20;4(1):e000347. doi: 10.1136/bmjsem-2018-000347. eCollection 2018.
- 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.
Philip von Rosen study chair
Karolinska Insitute
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 Lower Extremity Injury, run by Karolinska Institutet 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 20 Feb 2020. 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?
Lower extremity injury (time frame: March-June 2018 (10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03408925, which also lists 1 linked publication.
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 20 Feb 2020.