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

NCT01733381 | Completed

• 1 other identifier: 12-0370-02
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autonomic Nervous System (ANS) Functioning and Mood State

Keywords

Barefoot running, minimally shod running, non-invasive measures of autonomic nervous system (ANS) functioning and mood state.

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  Day 1 (Running day - no change is being assessed, participants run only ONCE during the study)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Avid barefoot runners and regular 'shoed' runners will be selected from local running groups and clubs.

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Human Evolutionary Biomechanics Laboratory in the Park Student Union, Room 236 at the University of Arizona

Tucson, Arizona, 85724, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 27, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 31, 2025

Record last verified: 2014-02

Locations

US (1)