HealthyNCT01536171
Peak Impact Forces and Metabolic Cost During Mid-Forefoot Striking in Shod Versus Barefoot Runners
An observational study of Healthy, run by University of Florida at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- running with normal running shoes and barefoot
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jul 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: trained runners (men and women) who run with a FM strike (self-reported and verified in the laboratory).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF&Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32611
About this study
Official title: Peak Impact Forces and Metabolic Cost During Mid-Forefoot Striking in Shod Versus Barefoot Runners: A Pilot Study
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)
Read the detailed description
Specific Aim 1: To identify if differences in metabolic cost exist between barefoot versus cushioned shod FM strikers during an acute bout of running exercise. Hypothesis: The metabolic cost will be higher in the cushioned shod runners with forefoot and midfoot strike compared to the barefoot runners.
Specific Aim 2: To identify if differences in peak impact forces exist between barefoot versus cushioned shod runners in forefoot-midfoot (FM) strikers.
Hypothesis: Peak impact forces will be higher in the barefoot runners with a forefoot and midfoot striking running style compared to the cushioned shod runners with a forefoot and midfoot striking running style.
- Conditions
- Healthy
- Being tested
- running with normal running shoes and barefoot
- Keywords
- runners, mid-foot strike, fore foot strike, metabolic costs, trained runners (men,women) with a FM strike, shod running, barefoot running
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
running with normal running shoes and barefootOther
shod condition: normal running shoes barefoot condition: running with no shoewear
| Study group | Role | What they receive |
|---|---|---|
| Shod versus Barefoot Running | two running conditions, with normal running shoes and barefoot Receives: Other: running with normal running shoes and barefoot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study consists of two visits, approximately 2 hours for each visit
Secondary outcomes (1)
Peak Impact Forces During Barefoot and Shod Running
This study will be measuring the peak impact forces that a runner produces when running 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.
Measured: Study consists of two visits, approximately 2 hours for each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather K Vincent, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536171
- Sponsor's protocol ID
- 497-2010
- Status last verified
- Mar 2014
- First submitted
- 2 Nov 2011
- Last updated
- 21 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peak Impact Forces and Metabolic Cost During Mid-Forefoot Striking in Shod Versus Barefoot Runners: A Pilot Study
- ClinicalTrials.gov ID
- NCT01536171
- Acronym / sponsor ID
- 497-2010
- Conditions
- Healthy
- Keywords
- runners, mid-foot strike, fore foot strike, metabolic costs, trained runners (men,women) with a FM strike, shod running, barefoot running
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 20 Feb 2012 (estimated)
- Results
- Posted 21 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Specific Aim 1: To identify if differences in metabolic cost exist between barefoot versus cushioned shod FM strikers during an acute bout of running exercise. Hypothesis: The metabolic cost will be higher in the cushioned shod runners with forefoot and midfoot strike compared to the barefoot runners.
Specific Aim 2: To identify if differences in peak impact forces exist between barefoot versus cushioned shod runners in forefoot-midfoot (FM) strikers.
Hypothesis: Peak impact forces will be higher in the barefoot runners with a forefoot and midfoot striking running style compared to the cushioned shod runners with a forefoot and midfoot striking running style.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shod versus Barefoot Running | – | Other: running with normal running shoes and barefoottwo running conditions, with normal running shoes and barefoot |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- trained runners (men and women) who run with a FM strike (self-reported and verified in the laboratory).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| running with normal running shoes and barefootshod condition: normal running shoes barefoot condition: running with no shoewear | Other | Shod versus Barefoot Running |
Primary outcome
Metabolic Rate During Barefoot and Shod Running
Time frame: Study consists of two visits, approximately 2 hours for each visit
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.
1 secondary outcome
Peak Impact Forces During Barefoot and Shod Running
Time frame: Study consists of two visits, approximately 2 hours for each visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Heather K Vincent, PhD principal investigator
University of Florida
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 Healthy, run by University of Florida at 1 site in United States.
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 4 inclusion and 7 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 21 Apr 2014. 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 United States. 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?
Yes. Results are posted in the registry (first posted 21 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Metabolic Rate During Barefoot and Shod Running (time frame: Study consists of two visits, approximately 2 hours for each visit). 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 21 Apr 2014.