<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01733381</url>
  </required_header>
  <id_info>
    <org_study_id>12-0370-02</org_study_id>
    <nct_id>NCT01733381</nct_id>
  </id_info>
  <brief_title>Effects of Barefoot Running vs. in Shoes on Physiology and Mood</brief_title>
  <official_title>An Examination of the Differential Effects of Running Minimally Shod vs. in Shoes on Physiology and Emotional States Relevant to Major Depression.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arizona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aerobic exercise impacts bodily processes implicated in the pathophysiology of major&#xD;
      depression. Consistent with these effects, aerobic exercise in general, and running in&#xD;
      particular, has been repeatedly shown to have both immediate mood elevating and longer-term&#xD;
      antidepressant effects. To the investigators' knowledge, all studies of running as a&#xD;
      therapeutic intervention for mood have had subjects run in standard running shoes, despite&#xD;
      increasing evidence that running barefoot or in shoes with minimal effect on foot strike&#xD;
      (i.e. &quot;minimally shod&quot;) leads to marked changes in how people run in ways that might have&#xD;
      physiological effects of relevance to health. Thus, nothing is currently known about&#xD;
      differences in effects on depression-relevant physiological or emotional functioning between&#xD;
      running either barefoot or minimally-shod vs. running in standard running shoes (hereafter&#xD;
      called &quot;shoed). The current pilot study is designed to begin addressing these issues by&#xD;
      examining effects of minimally shod vs. shoed running on non-invasive measures of autonomic&#xD;
      nervous system (ANS) functioning and mood state.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aerobic exercise impacts bodily processes implicated in the pathophysiology of major&#xD;
      depression. Consistent with these effects, aerobic exercise in general, and running in&#xD;
      particular, has been repeatedly shown to have both immediate mood elevating and longer-term&#xD;
      antidepressant effects. To the investigators' knowledge, all studies of running as a&#xD;
      therapeutic intervention for mood have had subjects run in standard running shoes, despite&#xD;
      increasing evidence that running barefoot or in shoes with minimal effect on foot strike&#xD;
      (i.e. &quot;minimally shod&quot;) leads to marked changes in how people run in ways that might have&#xD;
      physiological effects of relevance to health. Thus, nothing is currently known about&#xD;
      differences in effects on depression-relevant physiological or emotional functioning between&#xD;
      running either barefoot or minimally-shod vs. running in standard running shoes (hereafter&#xD;
      called &quot;shoed). The current pilot study is designed to begin addressing these issues by&#xD;
      examining effects of minimally shod vs. shoed running on non-invasive measures of autonomic&#xD;
      nervous system (ANS) functioning and mood state. The investigators have selected the ANS as&#xD;
      the physiological focus of the current study for several reasons including: 1) running&#xD;
      acutely alters ANS activity; 2) running (and aerobic fitness in general) is associated with&#xD;
      increased parasympathetic and reduced sympathetic activity at rest; 3) increased&#xD;
      parasympathetic tone in the body has been repeatedly associated with emotional well-being and&#xD;
      stress resilience, whereas reduced parasympathetic tone has been reliably associated with&#xD;
      major depression; 4) given increasing evidence that ancestral humans may have run&#xD;
      exceptionally long distances to hunt prey to exhaustion, it is likely that such running was&#xD;
      conducted under fairly significant parasympathetic tone to reduce energy expenditure; 5)&#xD;
      ancestral humans ran barefoot or minimally shod suggesting that the type of foot strike&#xD;
      pattern encouraged by these styles of running may have enhanced parasympathetic tone compared&#xD;
      to running with heel strike such as occurs when running shoed; and 6) therefore minimally&#xD;
      shod running might differentially impact parasympathetic tone in ways that would make it more&#xD;
      effective as a treatment for depression than running shoed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To examine whether running minimally-shod produces changes in ANS function both during and after running when compared to running shoed.</measure>
    <time_frame>Day 1 (Running day - no change is being assessed, participants run only ONCE during the study)</time_frame>
    <description>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.&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specific Aim 2: To examine whether running minimally-shod produces changes in emotional state both during and after running when compared to running shoed.</measure>
    <time_frame>Day 1 (Running day - no change is being assessed, participants run only ONCE during the study)</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To examine whether changes in ANS activity associated with running are associated with changes in mood.</measure>
    <time_frame>Day 1 (Running day - no change is being assessed, participants run only ONCE during the study)</time_frame>
    <description>Hypothesis 5: Parasympathetic tone both during and following running will be associated with self-reported mood both during and following running.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">22</enrollment>
  <condition>Autonomic Nervous System (ANS) Functioning and Mood State.</condition>
  <arm_group>
    <arm_group_label>Barefoot runners</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Shoed runners</arm_group_label>
    <description>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.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Avid barefoot runners and regular 'shoed' runners will be selected from local running&#xD;
        groups and clubs.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male/Female subjects between the ages of 18 and 45 at study entry (per a self report-&#xD;
             females must be in the follicular phase of their menstrual cycle, within ~14 days of&#xD;
             the end of their last period)&#xD;
&#xD;
          -  Fully ambulatory and in good medical health (see exclusion criteria below for&#xD;
             specifics)&#xD;
&#xD;
          -  Ability to read/understand English&#xD;
&#xD;
          -  Consistent practice of running at least three times a week for a total of at least 30&#xD;
             minutes at a time.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Potential subjects will be excluded for a diagnosis of any serious ongoing medical or&#xD;
             psychiatric condition that might unduly influence results or increase risk of study&#xD;
             participation, including but not limited to:&#xD;
&#xD;
               -  Malignancy&#xD;
&#xD;
               -  Auto-immune disorder&#xD;
&#xD;
               -  Cardiovascular disease (except treated hypertension)&#xD;
&#xD;
               -  Neurologic disorder&#xD;
&#xD;
               -  Endocrinopathy (other than treated hypothyroidism)&#xD;
&#xD;
               -  Chronic infection (i.e. human immunodeficiency virus, hepatitis B or C)&#xD;
&#xD;
               -  Any renal, hepatic or hematological abnormality (other than history of mild&#xD;
                  anemia)&#xD;
&#xD;
               -  Current major depression or major depression requiring hospitalization or&#xD;
                  resulting in suicide attempt in past year.&#xD;
&#xD;
          -  Subjects will also be excluded for use of medications that might impact ANS&#xD;
             functioning, including but not limited to beta-blockers, calcium channel blockers and&#xD;
             alpha-blockers, and any medication with anticholinergic properties (e.g., many&#xD;
             antihistamines).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Human Evolutionary Biomechanics Laboratory in the Park Student Union, Room 236 at the University of Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>February 4, 2014</last_update_submitted>
  <last_update_submitted_qc>February 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Barefoot running, minimally shod running, non-invasive measures of autonomic nervous system (ANS) functioning and mood state.</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01733381
org study id: 12-0370-02
nct id: NCT01733381
lead sponsor: 
has dmc: No
Aerobic exercise impacts bodily processes implicated in the pathophysiology of major
      depression. Consistent with these effects, aerobic exercise in general, and running in
      particular, has been repeatedly shown to have both immediate mood elevating and longer-term
      antidepressant effects. To the investigators' knowledge, all studies of running as a
      therapeutic intervention for mood have had subjects run in standard running shoes, despite
      increasing evidence that running barefoot or in shoes with minimal effect on foot strike
      (i.e. "minimally shod") leads to marked changes in how people run in ways that might have
      physiological effects of relevance to health. Thus, nothing is currently known about
      differences in effects on depression-relevant physiological or emotional functioning between
      running either barefoot or minimally-shod vs. running in standard running shoes (hereafter
      called "shoed). The current pilot study is designed to begin addressing these issues by
      examining effects of minimally shod vs. shoed running on non-invasive measures of autonomic
      nervous system (ANS) functioning and mood state.
Aerobic exercise impacts bodily processes implicated in the pathophysiology of major
      depression. Consistent with these effects, aerobic exercise in general, and running in
      particular, has been repeatedly shown to have both immediate mood elevating and longer-term
      antidepressant effects. To the investigators' knowledge, all studies of running as a
      therapeutic intervention for mood have had subjects run in standard running shoes, despite
      increasing evidence that running barefoot or in shoes with minimal effect on foot strike
      (i.e. "minimally shod") leads to marked changes in how people run in ways that might have
      physiological effects of relevance to health. Thus, nothing is currently known about
      differences in effects on depression-relevant physiological or emotional functioning between
      running either barefoot or minimally-shod vs. running in standard running shoes (hereafter
      called "shoed). The current pilot study is designed to begin addressing these issues by
      examining effects of minimally shod vs. shoed running on non-invasive measures of autonomic
      nervous system (ANS) functioning and mood state. The investigators have selected the ANS as
      the physiological focus of the current study for several reasons including: 1) running
      acutely alters ANS activity; 2) running (and aerobic fitness in general) is associated with
      increased parasympathetic and reduced sympathetic activity at rest; 3) increased
      parasympathetic tone in the body has been repeatedly associated with emotional well-being and
      stress resilience, whereas reduced parasympathetic tone has been reliably associated with
      major depression; 4) given increasing evidence that ancestral humans may have run
      exceptionally long distances to hunt prey to exhaustion, it is likely that such running was
      conducted under fairly significant parasympathetic tone to reduce energy expenditure; 5)
      ancestral humans ran barefoot or minimally shod suggesting that the type of foot strike
      pattern encouraged by these styles of running may have enhanced parasympathetic tone compared
      to running with heel strike such as occurs when running shoed; and 6) therefore minimally
      shod running might differentially impact parasympathetic tone in ways that would make it more
      effective as a treatment for depression than running shoed.
observational model: Case-Control
time perspective: Prospective
measure: 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)
description: 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.
measure: 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)
description: 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.
measure: 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)
description: Hypothesis 5: Parasympathetic tone both during and following running will be associated with self-reported mood both during and following running.
arm group label: Barefoot runners
description: 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.
arm group label: Shoed runners
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor