Barefoot RunningNCT02815826
16 Weeks of Progressive Barefoot Running Training Changes Impact Force and Muscle Activation in Habitual Shod Runners
An observational study of Barefoot Running, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Barefoot Running
- What is being tested?
- Barefoot training and Shod training
- How many people
- 6 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2012to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Habitual shod runners (recreational runners without experience in barefoot and/or minimatist running)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Short-term effects of barefoot and simulated barefoot running have been widely discussed in recent years. Consequences of adopting barefoot running for a long period, e.g. as training strategy, still remain unknown. The present study evaluated 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. During the 16 weeks of training, participants 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 weekly training volume (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. Training sessions were prepared by professionals, researches and participants together. All training sessions were supervised by the researchers. Tests consisted of running on instrumented treadmill at 9 km/h, for 10 minutes in each experimental condition. Each session test started with participants performing a maximum voluntary isometric contraction (MVIC) test for each muscle of interest. The MVIC protocol consisted of 4 movement trials for each muscle: 2 submaximal trials of 10 seconds; 1 maximal trial of 5 seconds; and 1 maximal trial of 10 seconds. Then, a 5-minute period of warm-up at self-selected speed was performed on a treadmill. After that, participants ran (at 9km/h) during 10 minutes on an instrumented treadmill in both barefoot and shod conditions. Participants had a 2-minute interval between each trial while experimental condition was changed. The VGRF of both legs and EMG signal of tibialis anterior (TA), gastrocnemius lateralis (GL), long head of biceps femoris (BCF), rectus femoris (RF) and vastus lateralis (VL) of the right leg of each volunteer were obtained. These muscles were chosen due to their importance and contribution to running. For shod trial, runners wore their own habitual running shoes. All shoes were in good conditions of use and had similar characteristics of construction.
- Conditions
- Barefoot Running
- Being tested
- Barefoot training, Shod training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barefoot trainingOther
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.
Shod trainingOther
Running training planned individually to each runner, according to their physical fitness, and performed with shoes.
| Study group | Role | What they receive |
|---|---|---|
| Barefoot training | 16 weeks of progressive barefoot running training Receives: Other: Barefoot training; Other: Shod training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startSep 2012
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barefoot RunningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Paula da Silva Azevedo, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815826
- Sponsor's protocol ID
- EEFEUSP_LBiomec-1
- Status last verified
- Jun 2016
- First submitted
- 22 Jun 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 16 Weeks of Progressive Barefoot Running Training Changes Impact Force and Muscle Activation in Habitual Shod Runners
- ClinicalTrials.gov ID
- NCT02815826
- Acronym / sponsor ID
- EEFEUSP_LBiomec-1
- Conditions
- Barefoot Running
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Short-term effects of barefoot and simulated barefoot running have been widely discussed in recent years. Consequences of adopting barefoot running for a long period, e.g. as training strategy, still remain unknown. The present study evaluated 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. During the 16 weeks of training, participants 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 weekly training volume (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. Training sessions were prepared by professionals, researches and participants together. All training sessions were supervised by the researchers. Tests consisted of running on instrumented treadmill at 9 km/h, for 10 minutes in each experimental condition. Each session test started with participants performing a maximum voluntary isometric contraction (MVIC) test for each muscle of interest. The MVIC protocol consisted of 4 movement trials for each muscle: 2 submaximal trials of 10 seconds; 1 maximal trial of 5 seconds; and 1 maximal trial of 10 seconds. Then, a 5-minute period of warm-up at self-selected speed was performed on a treadmill. After that, participants ran (at 9km/h) during 10 minutes on an instrumented treadmill in both barefoot and shod conditions. Participants had a 2-minute interval between each trial while experimental condition was changed. The VGRF of both legs and EMG signal of tibialis anterior (TA), gastrocnemius lateralis (GL), long head of biceps femoris (BCF), rectus femoris (RF) and vastus lateralis (VL) of the right leg of each volunteer were obtained. These muscles were chosen due to their importance and contribution to running. For shod trial, runners wore their own habitual running shoes. All shoes were in good conditions of use and had similar characteristics of construction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Barefoot training | – | Other: Barefoot training, Other: Shod training16 weeks of progressive barefoot running training |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Habitual shod runners (recreational runners without experience in barefoot and/or minimatist running)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barefoot trainingDuring 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. | Other | Barefoot training |
| Shod trainingRunning training planned individually to each runner, according to their physical fitness, and performed with shoes. | Other | Barefoot training |
Primary outcome
Parameters of the vertical component of Ground Reaction Force (VGRF) related to impact force
Time frame: 4 months
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.
Electromyographic (EMG) parameters related to muscle activation intensity
Time frame: 4 months
EMG signal will be measeured and the RMS, a parameter that reflects muscle activation intensity, will be evaluated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barefoot Running, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parameters of the vertical component of Ground Reaction Force (VGRF) related to impact force (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.