- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01733381
Effects of Barefoot Running vs. in Shoes on Physiology and Mood
An Examination of the Differential Effects of Running Minimally Shod vs. in Shoes on Physiology and Emotional States Relevant to Major Depression.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724
- Human Evolutionary Biomechanics Laboratory in the Park Student Union, Room 236 at the University of Arizona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male/Female subjects between the ages of 18 and 45 at study entry (per a self report- females must be in the follicular phase of their menstrual cycle, within ~14 days of the end of their last period)
- Fully ambulatory and in good medical health (see exclusion criteria below for specifics)
- Ability to read/understand English
- Consistent practice of running at least three times a week for a total of at least 30 minutes at a time.
Exclusion Criteria:
Potential subjects will be excluded for a diagnosis of any serious ongoing medical or psychiatric condition that might unduly influence results or increase risk of study participation, including but not limited to:
- Malignancy
- Auto-immune disorder
- Cardiovascular disease (except treated hypertension)
- Neurologic disorder
- Endocrinopathy (other than treated hypothyroidism)
- Chronic infection (i.e. human immunodeficiency virus, hepatitis B or C)
- Any renal, hepatic or hematological abnormality (other than history of mild anemia)
- Current major depression or major depression requiring hospitalization or resulting in suicide attempt in past year.
- Subjects will also be excluded for use of medications that might impact ANS functioning, including but not limited to beta-blockers, calcium channel blockers and alpha-blockers, and any medication with anticholinergic properties (e.g., many antihistamines).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Barefoot runners
This group of individuals will run in minimally shod foot ware.
For the purposes of this study we have defined this to be Vibram Five Finger shoes.
Participants will be runners who consistently run in these shoes at least 20 miles per week.
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Shoed runners
This group of individuals will run in normal running shoes.
Participants will be runners who consistently run in regular running shoes (that are not considered by industry standards to be minimal shoes) at least 20 miles per week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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To examine whether running minimally-shod produces changes in ANS function both during and after running when compared to running shoed.
Time Frame: Day 1 (Running day - no change is being assessed, participants run only ONCE during the study)
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Hypothesis 1: For any given amount of energy expenditure, running minimally shod will be associated with increased indices of parasympathetic tone when compared to running in shoes. Hypothesis 2: In all subjects, for any given amount of energy expenditure, the degree of forwardness of foot strike (i.e. toward toes and away from heel) will be correlated with increased measures of parasympathetic tone during and following running. |
Day 1 (Running day - no change is being assessed, participants run only ONCE during the study)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Specific Aim 2: To examine whether running minimally-shod produces changes in emotional state both during and after running when compared to running shoed.
Time Frame: Day 1 (Running day - no change is being assessed, participants run only ONCE during the study)
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Hypothesis 3: For any given amount of energy expenditure, running minimally shod will be associated with increased self-reported positive mood and reduced negative mood when compared to running in shoes. Hypothesis 4: In all subjects, for any given amount of energy expenditure, the degree of forwardness of foot strike (i.e. toward toes and away from heel) will be correlated with increased self-reported positive mood and reduced negative mood. |
Day 1 (Running day - no change is being assessed, participants run only ONCE during the study)
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To examine whether changes in ANS activity associated with running are associated with changes in mood.
Time Frame: Day 1 (Running day - no change is being assessed, participants run only ONCE during the study)
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Hypothesis 5: Parasympathetic tone both during and following running will be associated with self-reported mood both during and following running.
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Day 1 (Running day - no change is being assessed, participants run only ONCE during the study)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 12-0370-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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