Footwear Minimalism Study

Phase 2

Completed

• Conditions: Healthy Runners
• Interventions: Other: Nike Free 3.0; Other: Vibram Five Fingers Shoe; Other: Nike Pegasus

• Registration Number: NCT01334346
• Lead Sponsor: University of British Columbia

Brief 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. 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-04-12
• Study First Posted: 2011-04-13
• Study Start: 2011-08
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-27
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Partial minimalist shoe	Nike Free 3.0	-
Full minimalist	Vibram Five Fingers Shoe	-
Neutral Shoe	Nike Pegasus	Conventional, non-minimalist, footwear.

Primary Outcome Measures

Name	Time	Method
Number of Injury Events	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.

Secondary Outcome Measures

Name	Time	Method
Regional Specific NPS: Lower Back Pain	12 Week
Regional Specific NPS: Knee Pain	12 Weeks
Regional Specific NPS: Pelvis and Groin Pain	12 Week
Regional Specific NPS: Shin and Calf Pain	Week 12
Regional Specific NPS: Foot and Ankle Pain	12 Week
Foot and Ankle Disability Index (FADI)	Week 12
Numerical Pain Scale (NPS) for Overall Running Related Pain	Week 12

Trial Locations

Locations (1)

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada