Effects of Barefoot Running vs. in Shoes on Physiology and Mood (NCT01733381) | Clinical Trial Compass
CompletedNot Applicable
Effects of Barefoot Running vs. in Shoes on Physiology and Mood
United States22 participantsStarted 2012-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To examine whether running minimally-shod produces changes in ANS function both during and after running when compared to running shoed.
Timeframe: Day 1 (Running day - no change is being assessed, participants run only ONCE during the study)