Footwear Minimalism Study

This study has been completed.
Sponsor:
Collaborator:
Nike Inc.
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01334346
First received: April 11, 2011
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

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).


Condition Intervention Phase
Healthy Runners
Other: Nike Pegasus
Other: Nike Free 3.0
Other: Vibram Five Fingers Shoe
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Investigation on Footwear Minimalism and Injury Risk in Runners

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Number of Injury Events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Foot and Ankle Disability Index (FADI) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Numerical Pain Scale (NPS) for Overall Running Related Pain [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Regional Specific NPS: Shin and Calf Pain [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Regional Specific NPS: Foot and Ankle Pain [ Time Frame: 12 Week ] [ Designated as safety issue: No ]
  • Regional Specific NPS: Knee Pain [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Regional Specific NPS: Pelvis and Groin Pain [ Time Frame: 12 Week ] [ Designated as safety issue: No ]
  • Regional Specific NPS: Lower Back Pain [ Time Frame: 12 Week ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: August 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Neutral Shoe
Conventional, non-minimalist, footwear.
Other: Nike Pegasus
Conventional neutral supportive running footwear. Non minimalist.
Experimental: Partial minimalist shoe Other: Nike Free 3.0
Partial minimalist shoe with partially elevated heel, but with increased mid-sole flexibility.
Experimental: Full minimalist Other: Vibram Five Fingers Shoe
Full minimalist shoe. Virtually no mid-sole, therefore no heel elevation or forefoot rockering. A proxy for a barefoot running condition.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334346

Locations
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z3
Sponsors and Collaborators
University of British Columbia
Nike Inc.
Investigators
Principal Investigator: Jack Taunton, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01334346     History of Changes
Other Study ID Numbers: H11-00931
Study First Received: April 11, 2011
Last Updated: March 27, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Running
Footwear
Injury incidence
injury risk
pain

ClinicalTrials.gov processed this record on April 14, 2014