Treatment ErrorEarly Phase 1NCT02014987
Running Related Injury Among Novice Runners
A Early Phase 1 study testing Training programmes in people with Treatment Error and Overuse Injury, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
About 31% of the Danish population participates regularly in running. The positive health benefits of running have been well documented in the literature. Unfortunately, running has been connected with a high risk of injuries. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment Error, Overuse Injury
- What is being tested?
- Training programmes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2013to Jan 2016
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- both gender between 16-65 years
- no running-training within the last year
- less than 20 hours of sports activity within the last year (in total)
- internet access and mail address
- body mass index between 18.5 - 25 or 30-35
- owns a pair of running shoes
Who cannot join
- do not want to use a GPS watch
- unable or unwilling to follow the running regime in 4 consecutive weeks
- previous injury in lower extremity within the last 2 years
- unable to read or understand Danish
- former heart surgery
- known heart surgery
Show all 11Show fewer
- known lung disease
- diabetes
- current pregnancy
- known tendency to shortness of breath or chest pain with activity
- known tendency to leg pain when walking long distances
Trial locations and contacts
1 site in 1 country.
Sten Rasmussen, MD contact
Michael L. Bertelsen, PT contact
Denmark1 site, 1 recruiting
- Recruiting
Sten Rasmussen
Aalborg, Northern Jutland, 9000
Sten Rasmussen, MD, sten.rasmussen@rn.dk
Michael Bertelsen, PT, miclejber@gmail.com
About this study
Official title: The Initial Running Volume and Running Related Injury Among Novice Runners
About 31% of the Danish population participates regularly in running. The positive health benefits of running have been well documented in the literature. Unfortunately, running has been connected with a high risk of injuries.
Running related injuries can cause a long rehabilitation and may even force the runner to quit running permanently. To ensure that running can be practiced as a safe exercise activity prevention must be considered.
Read the detailed description
Training errors (i.e. excessive volume, sudden change of training routines etc.) are held to be the main reasons to running related injuries. Fortunately, training errors can be avoided as training characteristics (distance, duration, pace) can be controlled by the runner.
In order to avoiding training errors, especially excessive volume many novice runners follow 0-5 kilometres type training programmes. However, limited research has been conducted on the training volume of beginner programs and the risk of running related injuries.
The purpose of this study is to investigate the relationship between the running volume the first 4 weeks of a running regime and the risk of running related injuries among novice runners. The relationship between running volume and running related injuries will be investigated in proportion to their body mass index (BMI).
- Conditions
- Treatment Error, Overuse Injury
- Being tested
- Training programmes
- Keywords
- Running related injury, Overuse injury, Running pattern
- Medical subject headings
- Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training programmesBehavioural
Runners with a high body mass index follow two types of training programmes:
- a running programme of 3 kilometres per week
- a running programme 6 kilometres per week
The amount of running will be increased with 10 % per week.
| Study group | Role | What they receive |
|---|---|---|
| Running training programmes | Experimental | Runners with a high body mass index are going to follow a training programme of 3 kilometres per week compared to a training programme of 6 kilometres per week.
The amount of running will be increased with 10 % per week. Receives: Behavioral: Training programmes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Running related injury
An injury sustained on muscles, joints, tendons and/or bones during or after running. The injury must have caused a workout reduction (reduced distance, intensity, frequency etc.) for at least 7 days.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment ErrorStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Michael L. Bertelsen, PT, Study chair, Department of Publich Health, Aarhus UniversitySten Rasmussen, MD, Principal investigator, Northern Orthopaedic Division, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014987
- Sponsor's protocol ID
- N-20130035
- Status last verified
- Apr 2015
- First submitted
- 9 Dec 2013
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Initial Running Volume and Running Related Injury Among Novice Runners
- ClinicalTrials.gov ID
- NCT02014987
- Acronym / sponsor ID
- N-20130035
- Conditions
- Treatment Error, Overuse Injury
- Keywords
- Running related injury, Overuse injury, Running pattern
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- Jul 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 19 Dec 2013 (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.
About 31% of the Danish population participates regularly in running. The positive health benefits of running have been well documented in the literature. Unfortunately, running has been connected with a high risk of injuries.
Running related injuries can cause a long rehabilitation and may even force the runner to quit running permanently. To ensure that running can be practiced as a safe exercise activity prevention must be considered.
Detailed description
Training errors (i.e. excessive volume, sudden change of training routines etc.) are held to be the main reasons to running related injuries. Fortunately, training errors can be avoided as training characteristics (distance, duration, pace) can be controlled by the runner.
In order to avoiding training errors, especially excessive volume many novice runners follow 0-5 kilometres type training programmes. However, limited research has been conducted on the training volume of beginner programs and the risk of running related injuries.
The purpose of this study is to investigate the relationship between the running volume the first 4 weeks of a running regime and the risk of running related injuries among novice runners. The relationship between running volume and running related injuries will be investigated in proportion to their body mass index (BMI).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Running training programmes | Experimental | Behavioral: Training programmesRunners with a high body mass index are going to follow a training programme of 3 kilometres per week compared to a training programme of 6 kilometres per week. The amount of running will be increased with 10 % per week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- both gender between 16-65 years
- no running-training within the last year
- less than 20 hours of sports activity within the last year (in total)
- internet access and mail address
- body mass index between 18.5 - 25 or 30-35
Key exclusion criteria (11 listed)
- do not want to use a GPS watch
- unable or unwilling to follow the running regime in 4 consecutive weeks
- previous injury in lower extremity within the last 2 years
- unable to read or understand Danish
- former heart surgery
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 |
|---|---|---|
| Training programmesRunners with a high body mass index follow two types of training programmes: 1. a running programme of 3 kilometres per week 2. a running programme 6 kilometres per week The amount of running will be increased with 10 % per week. | Behavioural | Running training programmes |
Primary outcome
Running related injury
Time frame: 7 days
An injury sustained on muscles, joints, tendons and/or bones during or after running. The injury must have caused a workout reduction (reduced distance, intensity, frequency etc.) for at least 7 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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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.
Sten Rasmussen, MD contact
Michael L. Bertelsen, PT contact
Michael L. Bertelsen, PT study chair
Department of Publich Health, Aarhus University
Sten Rasmussen, MD principal investigator
Northern Orthopaedic Division, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Training programmes in people with Treatment Error and Overuse Injury, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 6 inclusion and 11 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 10 Apr 2015. 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 Denmark. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Sten Rasmussen, MD (sten.rasmussen@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Running related injury (time frame: 7 days). 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 10 Apr 2015.