Footwear Minimalism Study

Study Overview
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Brief Summary
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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).

Official Title
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An Investigation on Footwear Minimalism and Injury Risk in Runners

Conditions
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Healthy Runners

Intervention / Treatment
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* Other: Nike Pegasus
* Other: Nike Free 3.0
* Other: Vibram Five Fingers Shoe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neutral Shoe<br>Conventional, non-minimalist, footwear. | Other: Nike Pegasus<br>* Conventional neutral supportive running footwear. Non minimalist.<br>|
| Experimental: Partial minimalist shoe<br> | Other: Nike Free 3.0<br>* Partial minimalist shoe with partially elevated heel, but with increased mid-sole flexibility.<br>|
| Experimental: Full minimalist<br> | Other: Vibram Five Fingers Shoe<br>* Full minimalist shoe. Virtually no mid-sole, therefore no heel elevation or forefoot rockering. A proxy for a barefoot running condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot and Ankle Disability Index (FADI) |  | Week 12 | 
| Numerical Pain Scale (NPS) for Overall Running Related Pain |  | Week 12 | 
| Regional Specific NPS: Shin and Calf Pain |  | Week 12 | 
| Regional Specific NPS: Foot and Ankle Pain |  | 12 Week | 
| Regional Specific NPS: Knee Pain |  | 12 Weeks | 
| Regional Specific NPS: Pelvis and Groin Pain |  | 12 Week | 
| Regional Specific NPS: Lower Back Pain |  | 12 Week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Running, Footwear, Injury incidence, injury risk, pain