Athletic InjuriesNCT02788500
The Sports-Related Injuries and Illnesses in Para-sport Study (SRIIPS)
An observational study of Athletic Injuries, run by Lund University at 1 site in Sweden.
Trial summary
The overall aim of this project is to gain an in-depth understanding of the epidemiology of sports-related injuries and illnesses in parasport in order to assist the identification and development of specific injury prevention strategies adapted to parasport. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletic Injuries
- What is being tested?
- Incidence of sports-related injuries and illnesses
- How many people
- 107 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2016to Jan 2018
- Phase
- Observational
- 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
Study population: The total population of athletes (n=approximately 100) in the Swedish Paralympic program, which covers possbile candidates for the Paralympic Games.
Who may be able to join
- Age 18-55 years
- Being a registered competitive athlete within the Swedish Paralympic Program/Organization
- Being able to communicate in Swedish and having the opportunity to every week answer a web-based questionnaire.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Sports-Related Injuries and Illnesses in Para-sport Study (SRIIPS): A Prospective Longitudinal Study
The overall aim of this project is to gain an in-depth understanding of the epidemiology of sports-related injuries and illnesses in parasport in order to assist the identification and development of specific injury prevention strategies adapted to parasport.
Read the detailed description
The Paralympic Games is today one of the largest sport event in the world. During the last decades parasport has in many ways become elite sport, allowing people with disabilities to achieve extraordinary heights of functional capability. With the growing number of athletes there is an increased interest in athletes' health and safety, both to enhance sports performance and to prevent injuries.
Even though it is well-known that participation in sports places the athlete at risk for injuries, there are few studies covering sports-related injuries and illnesses in parasport (SRIIP). Today, some injuries and illnesses are known to be preventable. However, this requires regular monitoring of internal and external load during athletic preparation. Standardized injury surveillances have been implemented within several sports for abled-bodied athletes, but such studies do not yet exist within parasport.
In our review article (Fagher \& Lexell 2014) the investigators showed that existing studies of sports-related injuries in athletes with disabilities have a variable quality and that specific disability related factors have not been examined. Further studies are therefore warranted to obtain an increased in-depth knowledge of SRIIP. With a systematic longitudinal surveillance system tailored to parasport it would be possible to observe trends and risk factors over time, and thereby have a basis for developing specific preventive measures.
The overall aim of this project is to gain an in-depth understanding of the epidemiology of SRIIP in parasport in order to assist the identification and development of specific injury prevention strategies adapted to parasport.
The specific aims are: i) to design and implement a study protocol for prospective epidemiological studies of SRIIP in parasport; ii) to prospectively estimate the annual incidence of SRIIP among Swedish Paralympic athletes; and iii) to explore risk factors and mechanisms for sustaining SRIIP based on athlete exposure in order to form the basis for moving towards safe participation in parasport.
- Conditions
- Athletic Injuries
- Being tested
- Incidence of sports-related injuries and illnesses
- Keywords
- Epidemiology, Sports medicine, Research protocol, Athletic injuries, Sports for persons with disabilities
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incidence of sports-related injuries and illnessesOther
The SRIIP-study is an epidemiological cohort study aimed to prospectively collect self-report data on sports-related injuries and illnesses incidence and risk exposure during training and competition for approximately one year among Swedish para-athletes.
| Study group | Role | What they receive |
|---|---|---|
| Swedish para-athletes | The total population of athletes in the Swedish Paralympic program, which covers candidates for the Paralympic Summer or Winter Games, will be invited by mail to participate in the study and report their incidence of sports-related injuries and illnesses Receives: Other: Incidence of sports-related injuries and illnesses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sports-related injuries and illnesses
The athletes will be asked to self-report incidence of sports-related injuries and illnesses based on the surveillence systems developed by Jacobsson et al 2010 and Timpka 2014.
Measured: Weekly during one year
Secondary outcomes (3)
Exposure of training
The athletes will be asked to report exposure and perceived exertion of training (hours and minutes of training and rated perceived exertion (RPE) based on the RPE-scale).
Measured: Weekly during one year
Pain
The athletes will be asked to report their perceived pain during the week on a visual analogue scale (VAS) scale.
Measured: Weekly during one year
General well-being
The athletes will be asked to report their perceived general well-being based on questions from the Health-related quality of life questionnaire EQ-5D.
Measured: Weekly during one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Athletic InjuriesStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Jan Lexell, Lund University
- Investigators
- Jan Lexell, Professor, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788500
- Sponsor's protocol ID
- P2016-0069
- Status last verified
- Mar 2018
- First submitted
- 22 May 2016
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Fagher K, Lexell J. Sports-related injuries in athletes with disabilities. Scand J Med Sci Sports. 2014 Oct;24(5):e320-31. doi: 10.1111/sms.12175. Epub 2014 Jan 15.
PubMed 24422719Jacobsson J, Timpka T, Ekberg J, Kowalski J, Nilsson S, Renstrom P. Design of a protocol for large-scale epidemiological studies in individual sports: the Swedish Athletics injury study. Br J Sports Med. 2010 Dec;44(15):1106-11. doi: 10.1136/bjsm.2009.067678. Epub 2010 May 19.
PubMed 20484318Timpka T, Alonso JM, Jacobsson J, Junge A, Branco P, Clarsen B, Kowalski J, Mountjoy M, Nilsson S, Pluim B, Renstrom P, Ronsen O, Steffen K, Edouard P. Injury and illness definitions and data collection procedures for use in epidemiological studies in Athletics (track and field): consensus statement. Br J Sports Med. 2014 Apr;48(7):483-90. doi: 10.1136/bjsports-2013-093241.
PubMed 24620036Lexell J, Loven G, Fagher K. Incidence of sports-related concussion in elite para athletes - a 52-week prospective study. Brain Inj. 2021 Jul 3;35(8):971-977. doi: 10.1080/02699052.2021.1942551. Epub 2021 Jun 29.
PubMed 34185611Fagher K, Jacobsson J, Dahlstrom O, Timpka T, Lexell J. An eHealth Application of Self-Reported Sports-Related Injuries and Illnesses in Paralympic Sport: Pilot Feasibility and Usability Study. JMIR Hum Factors. 2017 Nov 29;4(4):e30. doi: 10.2196/humanfactors.8117.
PubMed 29187343Fagher K, Jacobsson J, Timpka T, Dahlstrom O, Lexell J. The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS): a study protocol for a prospective longitudinal study. BMC Sports Sci Med Rehabil. 2016 Aug 30;8(1):28. doi: 10.1186/s13102-016-0053-x. eCollection 2016.
PubMed 27579170
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sports-Related Injuries and Illnesses in Para-sport Study (SRIIPS): A Prospective Longitudinal Study
- ClinicalTrials.gov ID
- NCT02788500
- Acronym / sponsor ID
- P2016-0069
- Conditions
- Athletic Injuries
- Keywords
- Epidemiology, Sports medicine, Research protocol, Athletic injuries, Sports for persons with disabilities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- Nov 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 2 Jun 2016 (estimated)
- 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 overall aim of this project is to gain an in-depth understanding of the epidemiology of sports-related injuries and illnesses in parasport in order to assist the identification and development of specific injury prevention strategies adapted to parasport.
Detailed description
The Paralympic Games is today one of the largest sport event in the world. During the last decades parasport has in many ways become elite sport, allowing people with disabilities to achieve extraordinary heights of functional capability. With the growing number of athletes there is an increased interest in athletes' health and safety, both to enhance sports performance and to prevent injuries.
Even though it is well-known that participation in sports places the athlete at risk for injuries, there are few studies covering sports-related injuries and illnesses in parasport (SRIIP). Today, some injuries and illnesses are known to be preventable. However, this requires regular monitoring of internal and external load during athletic preparation. Standardized injury surveillances have been implemented within several sports for abled-bodied athletes, but such studies do not yet exist within parasport.
In our review article (Fagher \& Lexell 2014) the investigators showed that existing studies of sports-related injuries in athletes with disabilities have a variable quality and that specific disability related factors have not been examined. Further studies are therefore warranted to obtain an increased in-depth knowledge of SRIIP. With a systematic longitudinal surveillance system tailored to parasport it would be possible to observe trends and risk factors over time, and thereby have a basis for developing specific preventive measures.
The overall aim of this project is to gain an in-depth understanding of the epidemiology of SRIIP in parasport in order to assist the identification and development of specific injury prevention strategies adapted to parasport.
The specific aims are: i) to design and implement a study protocol for prospective epidemiological studies of SRIIP in parasport; ii) to prospectively estimate the annual incidence of SRIIP among Swedish Paralympic athletes; and iii) to explore risk factors and mechanisms for sustaining SRIIP based on athlete exposure in order to form the basis for moving towards safe participation in parasport.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Swedish para-athletes | – | Other: Incidence of sports-related injuries and illnessesThe total population of athletes in the Swedish Paralympic program, which covers candidates for the Paralympic Summer or Winter Games, will be invited by mail to participate in the study and report their incidence of sports-related injuries and illnesses |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The total population of athletes (n=approximately 100) in the Swedish Paralympic program, which covers possbile candidates for the Paralympic Games.
Key inclusion criteria (3 listed)
- Age 18-55 years
- Being a registered competitive athlete within the Swedish Paralympic Program/Organization
- Being able to communicate in Swedish and having the opportunity to every week answer a web-based questionnaire.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Incidence of sports-related injuries and illnessesThe SRIIP-study is an epidemiological cohort study aimed to prospectively collect self-report data on sports-related injuries and illnesses incidence and risk exposure during training and competition for approximately one year among Swedish para-athletes. | Other | Swedish para-athletes |
Primary outcome
Incidence of sports-related injuries and illnesses
Time frame: Weekly during one year
The athletes will be asked to self-report incidence of sports-related injuries and illnesses based on the surveillence systems developed by Jacobsson et al 2010 and Timpka 2014.
3 secondary outcomes
Exposure of training
Time frame: Weekly during one year
Pain
Time frame: Weekly during one year
General well-being
Time frame: Weekly during one year
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 7 Mar 2018.
- Background: PubMed 24422719Fagher K, Lexell J. Sports-related injuries in athletes with disabilities. Scand J Med Sci Sports. 2014 Oct;24(5):e320-31. doi: 10.1111/sms.12175. Epub 2014 Jan 15.
- Background: PubMed 20484318Jacobsson J, Timpka T, Ekberg J, Kowalski J, Nilsson S, Renstrom P. Design of a protocol for large-scale epidemiological studies in individual sports: the Swedish Athletics injury study. Br J Sports Med. 2010 Dec;44(15):1106-11. doi: 10.1136/bjsm.2009.067678. Epub 2010 May 19.
- Background: PubMed 24620036Timpka T, Alonso JM, Jacobsson J, Junge A, Branco P, Clarsen B, Kowalski J, Mountjoy M, Nilsson S, Pluim B, Renstrom P, Ronsen O, Steffen K, Edouard P. Injury and illness definitions and data collection procedures for use in epidemiological studies in Athletics (track and field): consensus statement. Br J Sports Med. 2014 Apr;48(7):483-90. doi: 10.1136/bjsports-2013-093241.
- Derived from this study: PubMed 34185611Lexell J, Loven G, Fagher K. Incidence of sports-related concussion in elite para athletes - a 52-week prospective study. Brain Inj. 2021 Jul 3;35(8):971-977. doi: 10.1080/02699052.2021.1942551. Epub 2021 Jun 29.
- Derived from this study: PubMed 29187343Fagher K, Jacobsson J, Dahlstrom O, Timpka T, Lexell J. An eHealth Application of Self-Reported Sports-Related Injuries and Illnesses in Paralympic Sport: Pilot Feasibility and Usability Study. JMIR Hum Factors. 2017 Nov 29;4(4):e30. doi: 10.2196/humanfactors.8117.
- Derived from this study: PubMed 27579170Fagher K, Jacobsson J, Timpka T, Dahlstrom O, Lexell J. The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS): a study protocol for a prospective longitudinal study. BMC Sports Sci Med Rehabil. 2016 Aug 30;8(1):28. doi: 10.1186/s13102-016-0053-x. eCollection 2016.
- 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.
Jan Lexell, Professor principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Athletic Injuries, run by Lund University 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 3 inclusion and 0 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 7 Mar 2018. 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?
Incidence of sports-related injuries and illnesses (time frame: Weekly during one year). 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 NCT02788500, which also lists 6 linked publications.
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 7 Mar 2018.