Footwear Minimalism Study

University of British Columbia

Status and phase: Completed; Phase 2

Conditions: Healthy Runners

Treatments: Other: Nike Free 3.0; Other: Nike Pegasus; Other: Vibram Five Fingers Shoe

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01334346

H11-00931

Details and patient eligibility

About

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).

Enrollment: 91 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 3 patient groups

Neutral Shoe

Active Comparator group

Description:

Conventional, non-minimalist, footwear.

Treatment:

Other: Nike Pegasus

Partial minimalist shoe

Experimental group

Treatment:

Other: Nike Free 3.0

Full minimalist

Experimental group

Treatment:

Other: Vibram Five Fingers Shoe