Musculoskeletal DiseasesNCT03636425
Musculoskeletal Disorders in Mountain Runners
An observational study of Musculoskeletal Diseases, run by University of Bologna at 1 site in Italy.
Trial summary
the study aims to estimate the prevalence of musculoskeletal disorders in a population of runners in the mountains; moreover it proposes to explore the relationship between distance traveled, the difference in height, the training frequency in the week, the shoes worn, the training method, the use of supports and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Questionnaire administration to gather information
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 30 Aug 2018to 30 Jan 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: mountain runners participating in competitions over the age of 18
Who may be able to join
- age over 18,
- be a participant of at least one mountain race
- understand the Italian language
- have signed an informed consent
Who cannot join
- under the age of 18
- do not understand Italian language
- not having given consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Musculoskeletal Disorders in Mountain Runners
the study aims to estimate the prevalence of musculoskeletal disorders in a population of runners in the mountains; moreover it proposes to explore the relationship between distance traveled, the difference in height, the training frequency in the week, the shoes worn, the training method, the use of supports and experience of running with musculoskeletal disorders. The secondary objectives of this study are to investigate to which rehabilitative figures the sportsman turns and if the treatments have positive outcomes.
Read the detailed description
Running is one of the most popular forms of exercise in the world. The prevalence of musculoskeletal disorders in street runners has already been extensively studied and is about 55% of those affected. In recent years, more and more runners paid their attention to mountain running where, the different types of terrain and the important differences in height require a different musculoskeletal effort. In the literature there are few studies that have investigated the prevalence of disorders, risk factors and protective factors on these runners. The mountain running performed with regularity and method is certainly a healthy activity for individuals, but it is not free from injuries due to several factors, such as long distance, significant differences in level and uneven terrain. It is not clear whether these factors can influence the onset of skeletal muscle disorders. The study aims to estimate the prevalence of musculoskeletal disorders in this population of mountain runners; moreover it proposes to explore in this population the relationship between distance traveled, the difference in height, the training frequency in the week, the shoes worn, the training method, the use of supports and experience of running with musculoskeletal disorders. Moreover, the study wants to investigate to which rehabilitative figures the sportsman turns and if the treatments have positive outcomes. Inclusion criteria are: age over 18, be a participant of at least one trail, understand the Italian language, to have signed informed consent. Recruitment: all participants in mountain races will be invited to reply to the attached questionnaire anonymously when the race bib is picked up. The runners will be free to participate or not in the survey, without the choice can affect the results of the race in any way and can create situations of subjection to the organization.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Questionnaire administration to gather information
- Keywords
- Running, Resistance Training, Mountain, Physiotherapy
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire administration to gather informationOther
In the questionnaire there are questions about the training (number of kilometers traveled by runners on average, total height difference, number of training sessions per week, training ground) questions on other activities carried out (gym, bicycle, etc.) number of competitions that runners participated in the month, used footwear, musculoskeletal disorders in the last 12 months, which health professional the runner has addressed, which physiotherapy therapies did.
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of musculoskeletal disorders
this outcome is self-reported
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start30 Aug 2018
- Primary completion20 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Pillastrini, University of Bologna
- Investigators
- Paolo Pillastrini, Principal investigator, Bologna University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636425
- Sponsor's protocol ID
- 07082018
- Status last verified
- Feb 2019
- First submitted
- 12 Aug 2018
- Last updated
- 11 Feb 2019
- 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 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Musculoskeletal Disorders in Mountain Runners
- ClinicalTrials.gov ID
- NCT03636425
- Acronym / sponsor ID
- 07082018
- Conditions
- Musculoskeletal Diseases
- Keywords
- Running, Resistance Training, Mountain, Physiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 17 Aug 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 study aims to estimate the prevalence of musculoskeletal disorders in a population of runners in the mountains; moreover it proposes to explore the relationship between distance traveled, the difference in height, the training frequency in the week, the shoes worn, the training method, the use of supports and experience of running with musculoskeletal disorders. The secondary objectives of this study are to investigate to which rehabilitative figures the sportsman turns and if the treatments have positive outcomes.
Detailed description
Running is one of the most popular forms of exercise in the world. The prevalence of musculoskeletal disorders in street runners has already been extensively studied and is about 55% of those affected. In recent years, more and more runners paid their attention to mountain running where, the different types of terrain and the important differences in height require a different musculoskeletal effort. In the literature there are few studies that have investigated the prevalence of disorders, risk factors and protective factors on these runners. The mountain running performed with regularity and method is certainly a healthy activity for individuals, but it is not free from injuries due to several factors, such as long distance, significant differences in level and uneven terrain. It is not clear whether these factors can influence the onset of skeletal muscle disorders. The study aims to estimate the prevalence of musculoskeletal disorders in this population of mountain runners; moreover it proposes to explore in this population the relationship between distance traveled, the difference in height, the training frequency in the week, the shoes worn, the training method, the use of supports and experience of running with musculoskeletal disorders. Moreover, the study wants to investigate to which rehabilitative figures the sportsman turns and if the treatments have positive outcomes. Inclusion criteria are: age over 18, be a participant of at least one trail, understand the Italian language, to have signed informed consent. Recruitment: all participants in mountain races will be invited to reply to the attached questionnaire anonymously when the race bib is picked up. The runners will be free to participate or not in the survey, without the choice can affect the results of the race in any way and can create situations of subjection to the organization.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- mountain runners participating in competitions over the age of 18
Key inclusion criteria (4 listed)
- age over 18,
- be a participant of at least one mountain race
- understand the Italian language
- have signed an informed consent
Key exclusion criteria (3 listed)
- under the age of 18
- do not understand Italian language
- not having given consent
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 |
|---|---|---|
| Questionnaire administration to gather informationIn the questionnaire there are questions about the training (number of kilometers traveled by runners on average, total height difference, number of training sessions per week, training ground) questions on other activities carried out (gym, bicycle, etc.) number of competitions that runners participated in the month, used footwear, musculoskeletal disorders in the last 12 months, which health professional the runner has addressed, which physiotherapy therapies did. | Other | – |
Primary outcome
presence of musculoskeletal disorders
Time frame: through study completion, an average of 6 months
this outcome is self-reported
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 11 Feb 2019.
- 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.
Paolo Pillastrini principal investigator
Bologna 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 Musculoskeletal Diseases, run by University of Bologna at 1 site in Italy.
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 4 inclusion and 3 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 11 Feb 2019. 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 Italy. 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?
presence of musculoskeletal disorders (time frame: through study completion, an average of 6 months). 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 11 Feb 2019.