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
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, see Learn About Clinical Studies.

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 July 20, 2014