NCT01334346

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

11 months

First QC Date

April 11, 2011

Last Update Submit

March 27, 2013

Conditions

Healthy Runners

Keywords

RunningFootwearInjury incidenceinjury riskpain

Outcome Measures

Primary Outcomes (1)

  • Number of Injury Events

    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.

    12 weeks

Secondary Outcomes (7)

  • Foot and Ankle Disability Index (FADI)

    Week 12

  • Numerical Pain Scale (NPS) for Overall Running Related Pain

    Week 12

  • Regional Specific NPS: Shin and Calf Pain

    Week 12

  • Regional Specific NPS: Foot and Ankle Pain

    12 Week

  • Regional Specific NPS: Knee Pain

    12 Weeks

  • +2 more secondary outcomes

Study Arms (3)

Neutral Shoe

ACTIVE COMPARATOR

Conventional, non-minimalist, footwear.

Other: Nike Pegasus

Partial minimalist shoe

EXPERIMENTAL
Other: Nike Free 3.0

Full minimalist

EXPERIMENTAL
Other: Vibram Five Fingers Shoe

Interventions

Nike PegasusOTHER

Conventional neutral supportive running footwear. Non minimalist.

Neutral Shoe
Nike Free 3.0OTHER

Partial minimalist shoe with partially elevated heel, but with increased mid-sole flexibility.

Partial minimalist shoe
Vibram Five Fingers ShoeOTHER

Full minimalist shoe. Virtually no mid-sole, therefore no heel elevation or forefoot rockering. A proxy for a barefoot running condition.

Full minimalist

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jack Taunton, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2011

First Posted

April 13, 2011

Study Start

August 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

CA(1)