Musculoskeletal InjuryNCT04385472
Musculoskeletal Imaging of Runners
An observational study of Musculoskeletal Injury, run by Royal National Orthopaedic Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
The investigators aimed to assess the impact of long-distance running on musculoskeletal system of runners, by doing high resolution magnetic resonance imaging analysis before and after marathon running. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Injury
- What is being tested?
- 3T MRI
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2019to 1 Dec 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: asymptomatic long-distance runners
Who may be able to join
- no previous marathon participations
- no present or previous history of hip injuries or surgeries
- asymptomatic hip joints
- no contradindications to hip MRI scanning
Who cannot join
- pregnant or breastfeeding women
- individuals aged <18 years
- claustrophobia
- history of anxiety or panic attacks
- known hip problems
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aimed to assess the impact of long-distance running on musculoskeletal system of runners, by doing high resolution magnetic resonance imaging analysis before and after marathon running.
Read the detailed description
Rationale for the study: This research will examine a key modifiable risk factor for health and well- being: exercise. Regular exercise is highly recommended by healthcare professionals because the whole body benefits, including cardiorespiratory, musculoskeletal systems and mental wellbeing. Long-distance running is a popular physical activity with more than 30 million individuals running marathons each year. The increasing participation of first-time runners, including older people, has been linked to a rise in related injuries. The ideal dose of exercise is not known and overdosage affects some musculoskeletal tissues and joints more than others. Overdoing a specific amount of exercise and the presence of chronic injuries may pose a great risk on the joints, leading to serious conditions such as osteoarthritis, musculoskeletal injuries, tendinopathy. However, it is not yet clear whether a high dose of exercise such as marathon running damages the musculoskeletal system and there is a growing need for research in the area of running science to better understand this.
Aim: This research aims to do musculoskeletal imaging before and after long-distance running using 3 Tesla magnetic resonance imaging and to provide evidence on how much exercise people should undertake and how to minimise injury.
- Conditions
- Musculoskeletal Injury
- Being tested
- 3T MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3T MRIRadiation
The main method used will be 3 Tesla MRI, which is a high resolution imaging technique. The participants will be asked to undergo musculoskeletal MRI scanning (pelvis and lumbar spine).MRI is a non-invasive procedure which excludes the risk of radiation (in comparison to other imaging modalities: X-ray, CT
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in radiographic score after marathon running
Measured: up to 1 year
Change in self-reported hip questionnaire after marathon running
Measured: up to 1 year
Secondary outcomes (1)
Number of participants who finished the training for/and the marathon vs not finishing
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Apr 2019
- Primary completion1 Feb 2020
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal InjuryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal National Orthopaedic Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Alister Hart, Royal National Orthopaedic Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385472
- Sponsor's protocol ID
- 13823/001
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Imaging of Runners
- ClinicalTrials.gov ID
- NCT04385472
- Acronym / sponsor ID
- 13823/001
- Conditions
- Musculoskeletal Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Royal National Orthopaedic Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 13 May 2020 (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 investigators aimed to assess the impact of long-distance running on musculoskeletal system of runners, by doing high resolution magnetic resonance imaging analysis before and after marathon running.
Detailed description
Rationale for the study: This research will examine a key modifiable risk factor for health and well- being: exercise. Regular exercise is highly recommended by healthcare professionals because the whole body benefits, including cardiorespiratory, musculoskeletal systems and mental wellbeing. Long-distance running is a popular physical activity with more than 30 million individuals running marathons each year. The increasing participation of first-time runners, including older people, has been linked to a rise in related injuries. The ideal dose of exercise is not known and overdosage affects some musculoskeletal tissues and joints more than others. Overdoing a specific amount of exercise and the presence of chronic injuries may pose a great risk on the joints, leading to serious conditions such as osteoarthritis, musculoskeletal injuries, tendinopathy. However, it is not yet clear whether a high dose of exercise such as marathon running damages the musculoskeletal system and there is a growing need for research in the area of running science to better understand this.
Aim: This research aims to do musculoskeletal imaging before and after long-distance running using 3 Tesla magnetic resonance imaging and to provide evidence on how much exercise people should undertake and how to minimise injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- asymptomatic long-distance runners
Key inclusion criteria (4 listed)
- no previous marathon participations
- no present or previous history of hip injuries or surgeries
- asymptomatic hip joints
- no contradindications to hip MRI scanning
Key exclusion criteria (5 listed)
- pregnant or breastfeeding women
- individuals aged <18 years
- claustrophobia
- history of anxiety or panic attacks
- known hip problems
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 |
|---|---|---|
| 3T MRIThe main method used will be 3 Tesla MRI, which is a high resolution imaging technique. The participants will be asked to undergo musculoskeletal MRI scanning (pelvis and lumbar spine).MRI is a non-invasive procedure which excludes the risk of radiation (in comparison to other imaging modalities: X-ray, CT | Radiation | – |
Primary outcome
Change in radiographic score after marathon running
Time frame: up to 1 year
Change in self-reported hip questionnaire after marathon running
Time frame: up to 1 year
1 secondary outcome
Number of participants who finished the training for/and the marathon vs not finishing
Time frame: up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Injury, run by Royal National Orthopaedic Hospital NHS Trust at 1 site in United Kingdom.
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 5 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: status not confirmed, as of the sponsor's last update on 13 May 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 United Kingdom. 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?
Results are not available in the source record.
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?
Change in radiographic score after marathon running (time frame: up to 1 year). The study lists 2 primary outcomes in all. 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 2020.