NCT02815826

Brief Summary

The purpose of this study was to evaluate the influence of 16 weeks of progressive barefoot running training on impact force and muscle activation in habitual shod runners. Habitual shod runners were tested barefoot (BF) and shod (SH), before and after 16 weeks of progressive barefoot running training. Tests consisted of running on instrumented treadmill at 9 km/h, for 10 minutes in each experimental condition. Nine data acquisitions (10 s) of vertical ground reaction force (VGRF) and electromyographic (EMG) signal were conducted in each experimental condition, for each test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

6 months

First QC Date

June 22, 2016

Last Update Submit

June 23, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Parameters of the vertical component of Ground Reaction Force (VGRF) related to impact force

    Biomechanical parameters related to impact forces, as magnitude of VGRF's first peak, time to reach first peak of VGRF and implulse from the first 50 ms, will be measured.

    4 months

  • Electromyographic (EMG) parameters related to muscle activation intensity

    EMG signal will be measeured and the RMS, a parameter that reflects muscle activation intensity, will be evaluated.

    4 months

Study Arms (1)

Barefoot training

16 weeks of progressive barefoot running training

Other: Barefoot trainingOther: Shod training

Interventions

During 16 weeks, habitual shod runners kept their normal running training routine (wearing shoes), while they were introduced progressively to BF condition. Three training sessions were performed per week. Barefoot training started with 5% and ended with 20% of their WTV being performed without shoes. Soft surfaces (i.e. sand and grass) were adopted in the beginning of training (week 1 to 8). From week 9 to 16, participants mixed soft with harder surfaces, as treadmill and asphalt, to accomplish the training.

Barefoot training

Running training planned individually to each runner, according to their physical fitness, and performed with shoes.

Barefoot training

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Habitual shod runners (recreational runners without experience in barefoot and/or minimatist running)

You may qualify if:

  • to have a minimum of 6 months of regular running training;
  • to have a minimum of 6 months of experience in running on treadmills;
  • do not have suffered any orthopedic injury in the last 12 months.

You may not qualify if:

  • to have experience in minimalist/barefoot running;
  • to be habitual forefoot striker;
  • to complete less than 80% of training;
  • to suffer any injury during training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ana Paula da Silva Azevedo

São Paulo, São Paulo, 05508-030, Brazil

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 28, 2016

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

June 28, 2016

Record last verified: 2016-06

Locations