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Footwear Minimalism Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01334346
First Posted: April 13, 2011
Last Update Posted: March 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nike
Information provided by (Responsible Party):
University of British Columbia
  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: None (Open Label)
Primary Purpose: Prevention
Official Title: An Investigation on Footwear Minimalism and Injury Risk in Runners

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334346


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

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01334346     History of Changes
Other Study ID Numbers: H11-00931
First Submitted: April 11, 2011
First Posted: April 13, 2011
Last Update Posted: March 29, 2013
Last Verified: March 2013

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