Healthy RunnersPhase 2NCT01334346
Footwear Minimalism Study
A Phase 2 study testing Nike Pegasus, Nike Free 3.0 and Vibram Five Fingers Shoe in people with Healthy Runners, run by University of British Columbia at 1 site in Canada.
Trial summary
The following study proposes to investigate the injury risk associated with the use of a new category of running footwear: the minimalist shoe. A group of experienced adult male and female runners with neutral foot types will take part in this study. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Runners
- What is being tested?
- Nike Pegasus, Nike Free 3.0 and Vibram Five Fingers Shoe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Jul 2012
- Phase
- Phase 2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Minimum of 5 years experience running
- Have been running on a regular basis (minimum once per week) over the past 6 months
- Able to run for 60 minutes continuously
- Can tolerate 20-40km per week in training
- Neutral foot posture according to the Foot Posture Index.
Who cannot join
- Have not experienced a running related injury requiring a stoppage of 2-weeks or more in the past 6 months
- History of surgery to their plantar fascia or Achilles tendon
- Have already been running in a minimalist shoe
- Have a diagnosis of osteoarthritis - or other degenerative musculoskeletal disorder - affecting the lower extremity
- Are currently taking analgesic medication.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: An Investigation on Footwear Minimalism and Injury Risk in Runners
The following study proposes to investigate the injury risk associated with the use of a new category of running footwear: the minimalist shoe. A group of experienced adult male and female runners with neutral foot types will take part in this study. All participants will be randomized to receive one of three different shoes: a full minimalist shoe (Vibram 5-Fingers), a partial minimalist shoe (Nike Free 3.0) and a conventional neutral supportive running shoe (Nike Pegasus), while training for a 10k event over a 14-week period. Outcomes to be investigated are pain, footwear perception, and number of injury events.
The hypothesizes is that participants using the minimalist footwear during their running program will experience a reduction in running related pain. A greater degree of footwear minimalism will result in a greater reduction in pain (compared to the partial minimalist shoe, Nike Free).
- Conditions
- Healthy Runners
- Being tested
- Nike Pegasus, Nike Free 3.0, Vibram Five Fingers Shoe
- Keywords
- Running, Footwear, Injury incidence, injury risk, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nike PegasusOther
Conventional neutral supportive running footwear. Non minimalist.
Nike Free 3.0Other
Partial minimalist shoe with partially elevated heel, but with increased mid-sole flexibility.
Vibram Five Fingers ShoeOther
Full minimalist shoe. Virtually no mid-sole, therefore no heel elevation or forefoot rockering. A proxy for a barefoot running condition.
| Study group | Role | What they receive |
|---|---|---|
| Neutral Shoe | Active comparator | Conventional, non-minimalist, footwear. Receives: Other: Nike Pegasus |
| Partial minimalist shoe | Experimental | Not described Receives: Other: Nike Free 3.0 |
| Full minimalist | Experimental | Not described Receives: Other: Vibram Five Fingers Shoe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Injury Events
Number of run injury events (defined as unable to complete 3 consecutive running workouts due to running related pain). A calculation of injury incidence will be based on this number after dividing by the number of athletic exposures.
Measured: 12 weeks
Secondary outcomes (7)
Foot and Ankle Disability Index (FADI)
Measured: Week 12
Numerical Pain Scale (NPS) for Overall Running Related Pain
Measured: Week 12
Regional Specific NPS: Shin and Calf Pain
Measured: Week 12
Regional Specific NPS: Foot and Ankle Pain
Measured: 12 Week
Regional Specific NPS: Knee Pain
Measured: 12 Weeks
Regional Specific NPS: Pelvis and Groin Pain
Measured: 12 Week
Regional Specific NPS: Lower Back Pain
Measured: 12 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy RunnersStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Nike
- Responsible party
- Sponsor
- Investigators
- Jack Taunton, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334346
- Sponsor's protocol ID
- H11-00931
- Status last verified
- Mar 2013
- First submitted
- 11 Apr 2011
- Last updated
- 29 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation on Footwear Minimalism and Injury Risk in Runners
- ClinicalTrials.gov ID
- NCT01334346
- Acronym / sponsor ID
- H11-00931
- Conditions
- Healthy Runners
- Keywords
- Running, Footwear, Injury incidence, injury risk, pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Nike
- Study start
- Aug 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Apr 2011 (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 following study proposes to investigate the injury risk associated with the use of a new category of running footwear: the minimalist shoe. A group of experienced adult male and female runners with neutral foot types will take part in this study. All participants will be randomized to receive one of three different shoes: a full minimalist shoe (Vibram 5-Fingers), a partial minimalist shoe (Nike Free 3.0) and a conventional neutral supportive running shoe (Nike Pegasus), while training for a 10k event over a 14-week period. Outcomes to be investigated are pain, footwear perception, and number of injury events.
The hypothesizes is that participants using the minimalist footwear during their running program will experience a reduction in running related pain. A greater degree of footwear minimalism will result in a greater reduction in pain (compared to the partial minimalist shoe, Nike Free).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neutral Shoe | Active comparator | Other: Nike PegasusConventional, non-minimalist, footwear. |
| Partial minimalist shoe | Experimental | Other: Nike Free 3.0 |
| Full minimalist | Experimental | Other: Vibram Five Fingers Shoe |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Minimum of 5 years experience running
- Have been running on a regular basis (minimum once per week) over the past 6 months
- Able to run for 60 minutes continuously
- Can tolerate 20-40km per week in training
- Neutral foot posture according to the Foot Posture Index.
Key exclusion criteria (5 listed)
- Have not experienced a running related injury requiring a stoppage of 2-weeks or more in the past 6 months
- History of surgery to their plantar fascia or Achilles tendon
- Have already been running in a minimalist shoe
- Have a diagnosis of osteoarthritis - or other degenerative musculoskeletal disorder - affecting the lower extremity
- Are currently taking analgesic medication.
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 |
|---|---|---|
| Nike PegasusConventional neutral supportive running footwear. Non minimalist. | Other | Neutral Shoe |
| Nike Free 3.0Partial minimalist shoe with partially elevated heel, but with increased mid-sole flexibility. | Other | Partial minimalist shoe |
| Vibram Five Fingers ShoeFull minimalist shoe. Virtually no mid-sole, therefore no heel elevation or forefoot rockering. A proxy for a barefoot running condition. | Other | Full minimalist |
Primary outcome
Number of Injury Events
Time frame: 12 weeks
Number of run injury events (defined as unable to complete 3 consecutive running workouts due to running related pain). A calculation of injury incidence will be based on this number after dividing by the number of athletic exposures.
7 secondary outcomes
Foot and Ankle Disability Index (FADI)
Time frame: Week 12
Numerical Pain Scale (NPS) for Overall Running Related Pain
Time frame: Week 12
Regional Specific NPS: Shin and Calf Pain
Time frame: Week 12
Regional Specific NPS: Foot and Ankle Pain
Time frame: 12 Week
Regional Specific NPS: Knee Pain
Time frame: 12 Weeks
Regional Specific NPS: Pelvis and Groin Pain
Time frame: 12 Week
Regional Specific NPS: Lower Back Pain
Time frame: 12 Week
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 29 Mar 2013.
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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.
Jack Taunton, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nike Pegasus, Nike Free 3.0 and Vibram Five Fingers Shoe in people with Healthy Runners, run by University of British Columbia at 1 site in Canada.
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 5 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: finished, as of the sponsor's last update on 29 Mar 2013. 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 Canada. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of Injury Events (time frame: 12 weeks). 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 29 Mar 2013.