Tucson, Arizona 85724

  • Autonomic Nervous System (ANS) Functioning and Mood State.

Purpose:

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.


Study 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. 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.


Criteria:

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 is Available At:


Original ID:

12-0370-02


NCT ID:

NCT01733381


Secondary ID:


Study Acronym:


Brief Title:

Effects of Barefoot Running vs. in Shoes on Physiology and Mood


Official Title:

An Examination of the Differential Effects of Running Minimally Shod vs. in Shoes on Physiology and Emotional States Relevant to Major Depression.


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Arizona


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspectiv


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

22


Enrollment Type:

Actual


Study Dates

Start Date:November 2012
Completion Date:February 2014
Completion Type:Actual
Primary Completion Date:February 2014
Primary Completion Type:Actual
Verification Date:February 2014
Last Changed Date:February 4, 2014
First Received Date:November 14, 2012

Study Outcomes

Outcome Type:Secondary Outcome
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)
Safety Issues:False
Description:Hypothesis 5: Parasympathetic tone both during and following running will be associated with self-reported mood both during and following running.
Outcome Type: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.
Time Frame:Day 1 (Running day - no change is being assessed, participants run only ONCE during the study)
Safety Issues:False
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 amoun
Outcome Type: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)
Safety Issues:False
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 expenditur

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name: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 Arm Type:Other
Arm Name: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Arizona

Samples and Retentions

Study Population: Avid barefoot runners and regular 'shoed' runners will be selected from local running groups and clubs.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


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