Running Related InjuriesNCT02349373
Focus of a Running Schedule and Risk of Running Injuries
A study testing An 8 week preconditioning period and 16 week training period in people with Running Related Injuries, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
Running is a natural part of human locomotion and humans have been running for million of years. In modern society, running has become a popular way of exercise and is undertaken by many people worldwide, possibly because it provides a cheap and easily accessible form of exercise, and the positive effects of running… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Running Related Injuries
- What is being tested?
- An 8 week preconditioning period and 16 week training period
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 839 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2015to Oct 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- on average 1-3 weekly running sessions the past 6 months
- owns a pair of running shoes
- internet access and mail address
- owns a Garmin GPS watch (pulse rate watch) or an IPhone/Android phone
Who cannot join
- previous injury in lower extremity within the past 6 months
- unable to follow the running regime in 6 consecutive months
- do not want to use GPS (Global Positioning System) watch or Android/Smart phone to register training
- unable to read or understand Danish
- deprecated by personal GP (General Practitioner) to run due to former surgery or physical disease
- mental condition that does not allow participation (e.g. externalizing behaviors, dementia)
- pregnancy
- participants with blood pressure above normal according to WHO guidelines will need to consult own GP (General Practitioner) for approval
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital
Aalborg, 9000
About this study
Official title: The Focus of a Running Schedule and Its Association With the Risk of Running Injuries? A Randomized Trial.
Running is a natural part of human locomotion and humans have been running for million of years. In modern society, running has become a popular way of exercise and is undertaken by many people worldwide, possibly because it provides a cheap and easily accessible form of exercise, and the positive effects of running on health and fitness are well known. Unfortunately, running is also associated with a high risk of injury.
The purpose of this project is to investigate how a running schedule which focuses either on running distance or running speed influence the overall risk of injury and the types of injury sustained in recreational runners.
Read the detailed description
Trails directed at investigating differences in injury risk in relation to the focus of the running schedule have been conducted without any firm conclusions. People engaged in recreational running or choosing running as a new and active lifestyle needs guidance on which running schedules minimize the injury risk, aiding their chance of an active lifestyle and possibly reversing the increase in people developing a lifestyle disease. To develop running schedules minimizing the risk of injury, an understanding of the mechanisms that the different training variables impose on the human body is necessary. The existing literature on running intensity and the development of injuries show conflicting result. More studies are necessary to ascertain if there is a relationship between the intensity of running. In such studies, it is important to include other training variables in the analysis and to quantify running exposure using an objective method of measuring the relative intensity and absolute volume.
- Conditions
- Running Related Injuries
- Being tested
- An 8 week preconditioning period, 16 week training period
- Keywords
- Overuse injury, Running related 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.
An 8 week preconditioning periodBehavioural
Receipt of a weekly running schedule through an online training diary.
16 week training periodBehavioural
Receipt of a weekly running schedule through an online training diary.
| Study group | Role | What they receive |
|---|---|---|
| Preconditioning running | Active comparator | An 8 week preconditioning period. The variables of interest are running distance and running intensity: running speed >80% VO2max (maximal oxygen uptake). Receives: Behavioral: An 8 week preconditioning period |
| Follow-up period | Active comparator | The Volume group progress 23% in total weekly running distance in the last adaptation week in the prior 4 week block.
The Intensity group progress 23% in weekly distance of running above 80% VO2 max (maximal oxygen uptake), based on the distance of running above 80% VO2max in the last adaptation week in the prior 4 week block. Receives: Behavioral: 16 week training period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Running Related Injury (RRI)
An injury will be reported through the online training diary. If the runners are injured an appointment for clinical examination is made with the diagnostic staff.
Measured: 24 weeks
Secondary outcomes (1)
Symptoms of overuse injury
A physical problem perceived as pain, tenderness, stiffness, aching, looseness and instability in any part of the body.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionOct 2017
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 Running Related InjuriesStudies 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 839 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Sten Rasmussen, M.D., Study chair, Aalborg University HospitalDaniel R. Joergensen, PhD student, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349373
- Sponsor's protocol ID
- N-20140069
- Status last verified
- Feb 2018
- First submitted
- 23 Jan 2015
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ramskov D, Nielsen RO, Sorensen H, Parner E, Lind M, Rasmussen S. The design of the run Clever randomized trial: running volume, -intensity and running-related injuries. BMC Musculoskelet Disord. 2016 Apr 23;17:177. doi: 10.1186/s12891-016-1020-0.
PubMed 27107810
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Focus of a Running Schedule and Its Association With the Risk of Running Injuries? A Randomized Trial.
- ClinicalTrials.gov ID
- NCT02349373
- Acronym / sponsor ID
- N-20140069
- Conditions
- Running Related Injuries
- Keywords
- Overuse injury, Running related injury, Running pattern
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 839 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- Apr 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 28 Jan 2015 (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.
Running is a natural part of human locomotion and humans have been running for million of years. In modern society, running has become a popular way of exercise and is undertaken by many people worldwide, possibly because it provides a cheap and easily accessible form of exercise, and the positive effects of running on health and fitness are well known. Unfortunately, running is also associated with a high risk of injury.
The purpose of this project is to investigate how a running schedule which focuses either on running distance or running speed influence the overall risk of injury and the types of injury sustained in recreational runners.
Detailed description
Trails directed at investigating differences in injury risk in relation to the focus of the running schedule have been conducted without any firm conclusions. People engaged in recreational running or choosing running as a new and active lifestyle needs guidance on which running schedules minimize the injury risk, aiding their chance of an active lifestyle and possibly reversing the increase in people developing a lifestyle disease. To develop running schedules minimizing the risk of injury, an understanding of the mechanisms that the different training variables impose on the human body is necessary. The existing literature on running intensity and the development of injuries show conflicting result. More studies are necessary to ascertain if there is a relationship between the intensity of running. In such studies, it is important to include other training variables in the analysis and to quantify running exposure using an objective method of measuring the relative intensity and absolute volume.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preconditioning running | Active comparator | Behavioral: An 8 week preconditioning periodAn 8 week preconditioning period. The variables of interest are running distance and running intensity: running speed >80% VO2max (maximal oxygen uptake). |
| Follow-up period | Active comparator | Behavioral: 16 week training periodThe Volume group progress 23% in total weekly running distance in the last adaptation week in the prior 4 week block. The Intensity group progress 23% in weekly distance of running above 80% VO2 max (maximal oxygen uptake), based on the distance of running above 80% VO2max in the last adaptation week in the prior 4 week block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- on average 1-3 weekly running sessions the past 6 months
- owns a pair of running shoes
- internet access and mail address
- owns a Garmin GPS watch (pulse rate watch) or an IPhone/Android phone
Key exclusion criteria (8 listed)
- previous injury in lower extremity within the past 6 months
- unable to follow the running regime in 6 consecutive months
- do not want to use GPS (Global Positioning System) watch or Android/Smart phone to register training
- unable to read or understand Danish
- deprecated by personal GP (General Practitioner) to run due to former surgery or physical disease
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 |
|---|---|---|
| An 8 week preconditioning periodReceipt of a weekly running schedule through an online training diary. | Behavioural | Preconditioning running |
| 16 week training periodReceipt of a weekly running schedule through an online training diary. | Behavioural | Follow-up period |
Primary outcome
Running Related Injury (RRI)
Time frame: 24 weeks
An injury will be reported through the online training diary. If the runners are injured an appointment for clinical examination is made with the diagnostic staff.
1 secondary outcome
Symptoms of overuse injury
Time frame: 24 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 6 Feb 2018.
- Derived from this study: PubMed 27107810Ramskov D, Nielsen RO, Sorensen H, Parner E, Lind M, Rasmussen S. The design of the run Clever randomized trial: running volume, -intensity and running-related injuries. BMC Musculoskelet Disord. 2016 Apr 23;17:177. doi: 10.1186/s12891-016-1020-0.
Related trials for Running Related Injuries
Active, not recruiting
Effect of Shoe Cushioning Position and Properties on Running-related Injury Risk
Running-related Injury
Not yet recruiting
Comparing Effects of Custom Foot Orthotic Intervention to Foot-Core Training Protocol on Lower Extremity Kinematics in Runners With Pes Planus
Pes Planus, Running Related Injuries
Not yet recruiting
Structured Neuromuscular Exercise Program
Running Biomechanics, Neuromuscular Control
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, M.D. study chair
Aalborg University Hospital
Daniel R. Joergensen, PhD student principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An 8 week preconditioning period and 16 week training period in people with Running Related Injuries, 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 4 inclusion and 8 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 6 Feb 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 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.
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?
Running Related Injury (RRI) (time frame: 24 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 NCT02349373, 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 6 Feb 2018.