Autonomic Nervous System (ANS) Functioning and Mood StateNCT01733381
Effects of Barefoot Running vs. in Shoes on Physiology and Mood
An observational study of Autonomic Nervous System (ANS) Functioning and Mood State, run by University of Arizona at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System (ANS) Functioning and Mood State
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Feb 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Avid barefoot runners and regular 'shoed' runners will be selected from local running groups and clubs.
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Evolutionary Biomechanics Laboratory in the Park Student Union, Room 236 at the University of Arizona
Tucson, Arizona, 85724
About this study
Official title: An Examination of the Differential Effects of Running Minimally Shod vs. in Shoes on Physiology and Emotional States Relevant to Major Depression.
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.
Read the detailed description
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.
- Keywords
- Barefoot running, minimally shod running, non-invasive measures of autonomic nervous system (ANS) functioning and mood state.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine whether running minimally-shod produces changes in ANS function both during and after running when compared to running shoed.
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.
Measured: Day 1 (Running day - no change is being assessed, participants run only ONCE during the study)
Secondary outcomes (2)
Specific Aim 2: To examine whether running minimally-shod produces changes in emotional state both during and after running when compared to running shoed.
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.
Measured: Day 1 (Running day - no change is being assessed, participants run only ONCE during the study)
To examine whether changes in ANS activity associated with running are associated with changes in mood.
Hypothesis 5: Parasympathetic tone both during and following running will be associated with self-reported mood both during and following running.
Measured: Day 1 (Running day - no change is being assessed, participants run only ONCE during the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous System (ANS) Functioning and Mood StateStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733381
- Sponsor's protocol ID
- 12-0370-02
- Status last verified
- Feb 2014
- First submitted
- 14 Nov 2012
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of the Differential Effects of Running Minimally Shod vs. in Shoes on Physiology and Emotional States Relevant to Major Depression.
- ClinicalTrials.gov ID
- NCT01733381
- Acronym / sponsor ID
- 12-0370-02
- Keywords
- Barefoot running, minimally shod running, non-invasive measures of autonomic nervous system (ANS) functioning and mood state.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Nov 2012 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Avid barefoot runners and regular 'shoed' runners will be selected from local running groups and clubs.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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.
2 secondary outcomes
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)
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)
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 31 Jul 2025.
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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.
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 Autonomic Nervous System (ANS) Functioning and Mood State, run by University of Arizona 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 10 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 31 Jul 2025. 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?
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?
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)). 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 31 Jul 2025.