Footwear Minimalism Study
This study has been completed.
Sponsor:
University of British Columbia
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
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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 May 23, 2013