Acute Exercise With Overdressing (NCT07080853) | Clinical Trial Compass
CompletedNot Applicable
Acute Exercise With Overdressing
United States23 participantsStarted 2023-06-22
Plain-language summary
The purpose of this study is to determine if exercise with extra clothing in a gym-like environment can increase body temperatures appropriately to help people adapt to the heat.
Who can participate
Age range
18 Years – 45 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 or female, age 18-45
* Females must be premenopausal
* Body mass index 18.5-30.0 kg m-2
* In good health as determined by the Office of Medical Support \& Oversight (OMSO) General Medical Clearance
* Performs aerobic exercise at least 2 times per week and capable of running 2 miles in under 16:00 (8 minute mile pace)
* Willing to abstain from exercise and alcoholic beverages for 24 hours before each study visit.
* Willing to abstain from caffeine for 12 hours prior to all study visits.
* Willing to abstain from food for 2 hours prior to all study visits.
* Willing to abstain from nicotine/tobacco for at least 8 hours prior to all study visits.
* Have supervisor approval if permanent party military or a federal employee at U.S. Army Natick Soldier System Center
Exclusion Criteria:
* Females who are pregnant or planning to become pregnant during the study
* Taking dietary supplements, prescriptions, or over the counter medication, other than a contraceptive (unless approved by OMSO \& PI)
* Abnormal blood count during OMSO medical screening (For example: hemoglobin (Hb) outside of the typical normal values reported by LabCorp in accordance with OMSO (Normal \[Hb\] Males = 12.6-17.7 g/dL; Females = 11.1-15.9 g/dL) or hematocrit (Hct) outside of the normal ranges (Normal Hct Males = 37.5-51.0%; Females = 34.0-46.6%) levels, presence of abnormal blood chemicals (hemoglobin S or sickle cell traits)
* Any history of pulmonary or cardiovascular disease
*…
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
Core temperature
Timeframe: Up to 90 minutes
2
Heart Rate
Timeframe: Up to 90 minutes
3
Skin temperature
Timeframe: Up to 90 minutes
4
Whole-body sweat loss
Timeframe: 90 minutes
Trial details
NCT IDNCT07080853
SponsorUnited States Army Research Institute of Environmental Medicine