Footwear Minimalism Study | NCT01334346

Studies
Footwear Minimalism Study

NCT01334346

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Mar 29, 2013Estimated

Enrollment

91Actual

Phase

Phase 2

Conditions

Healthy Runners

Interventions

Nike Pegasus
Nike Free 3.0
Vibram Five Fingers Shoe

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Apr 11, 2011

First Submission Date that Met QC Criteria

Apr 12, 2011

First Posted Date

Apr 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2013

Last Update Posted Date

Mar 29, 2013Estimated

Name	Class
Nike	INDUSTRY

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

91Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nike Pegasus	Other	Conventional neutral supportive running footwear. Non minimalist.	Neutral Shoe

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jack Taunton, MD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of British Columbia		Vancouver	British Columbia	V6T 1Z3	Canada

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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