NCT01536171

Brief Summary

This experimental study will compare impact forces and metabolic cost in runners (N=20; ages 18-45 years, who already use a forefoot strike running gait) in two treadmill running test sessions (shod vs barefoot running)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 20, 2012

Completed
4 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
1.8 years until next milestone

Results Posted

Study results publicly available

April 21, 2014

Completed
Last Updated

April 21, 2014

Status Verified

March 1, 2014

Enrollment Period

10 months

First QC Date

November 2, 2011

Results QC Date

December 13, 2013

Last Update Submit

March 17, 2014

Conditions

Keywords

runnersmid-foot strikefore foot strikemetabolic coststrained runners (men,women) with a FM strikeshod runningbarefoot running

Outcome Measures

Primary Outcomes (1)

  • Metabolic Rate During Barefoot and Shod Running

    This study will measure the metabolic rate when a person runs on the treadmill with shoes (shod) and without shoes. Each person will run for 20 minutes on the treadmill on two different days, one with and one day without shoes.

    Study consists of two visits, approximately 2 hours for each visit

Secondary Outcomes (1)

  • Peak Impact Forces During Barefoot and Shod Running

    Study consists of two visits, approximately 2 hours for each visit

Study Arms (1)

Shod versus Barefoot Running

two running conditions, with normal running shoes and barefoot

Other: running with normal running shoes and barefoot

Interventions

shod condition: normal running shoes barefoot condition: running with no shoewear

Shod versus Barefoot Running

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

trained runners (men and women) who run with a FM strike (self-reported and verified in the laboratory).

You may qualify if:

  • trained runners with a running foot striking style of either initial forefoot or midfoot strike.
  • run on average at least 20 miles/week
  • be able to run for at least 20 minutes at one session
  • free of any orthopedic limitation

You may not qualify if:

  • history of lower extremity injury within the last 6 months prior to testing
  • rear-foot strike running style
  • does not run in a cushioned shoe on any occasion
  • runs on average \< 20 miles/week
  • unable to run for 20 minutes or greater
  • presence of any open wound or deformity on the feet which would prevent participant from running barefoot
  • neurologic injury that would preclude normal running activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Interventions

Running

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Results Point of Contact

Title
Dr. Heather K. Vincent, PhD
Organization
University of Florida

Study Officials

  • Heather K Vincent, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2011

First Posted

February 20, 2012

Study Start

September 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

April 21, 2014

Results First Posted

April 21, 2014

Record last verified: 2014-03

Locations