Chronic Exercise With Overdressing
Chronic-XO
Efficacy of a Novel Exercise + Overdressing Protocol to Induce Heat Acclimation in Temperate Environments (Chronic XO-Study)
1 other identifier
interventional
13
1 country
1
Brief Summary
The purpose of this study is to determine if five training sessions of exercise with overdressing can induce heat acclimation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2025
CompletedFirst Submitted
Initial submission to the registry
June 26, 2025
CompletedFirst Posted
Study publicly available on registry
August 1, 2025
CompletedAugust 1, 2025
July 1, 2025
6 months
June 26, 2025
July 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
End-exercise Core Temperature
End-exercise core temperature during heat stress test
Through study completion, an average of 8 weeks
Resting Core Temperature
Core Temperature at Rest during Heat Stress Test
Through study completion, an average of 8 weeks
End-exercise heart rate
Heart rate at end of heat stress test
Through study completion, an average of 8 weeks
End-exercise Mean Weighted Skin Temperature
Mean weighted Skin temperature at end of heat stress test
Through study completion, an average of 8 weeks
Secondary Outcomes (1)
Urine Specific Gravity
Through study completion, an average of 8 weeks
Study Arms (2)
Exercise with Overdressing
EXPERIMENTAL5 days of standardized exercise with overdressing
Exercise
ACTIVE COMPARATOR5 days of standardized exercise wearing PT clothing
Interventions
Wear normal attire (shorts/t-shirt) during exercise sessions in a gym-like environment.
Wear standardized overdressing ensemble during exercise sessions in a gym-like environment.
Eligibility Criteria
You may qualify if:
- Females must be premenopausal.
- Body mass index 18.5-33.0 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 17:00 (8:30 minute mile pace).
- Willing to abstain from exercise and alcoholic beverages for 24 hrs before each study visit.
- Willing to abstain from caffeine for 12 hrs prior to all study visits.
- Willing to abstain from food for 2 hrs prior to all study visits.
- Willing to abstain from nicotine/tobacco for at least 8 hrs prior to all study visits.
- Have supervisor approval if permanent party military or a federal employee at U.S. Army Natick Soldier System Center.
You may not qualify if:
- Frequent hot bath or sauna users (e.g., more than three times a week for the past month).
- 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, cardiovascular, or renal disease (unless approved by OMSO \& PI).
- Uncontrolled asthma.
- Current or recent respiratory tract or sinus infections (\< 2 weeks prior).
- History of heat stroke or orthostatic intolerance.
- Diagnosed and/or treated for fluid/electrolyte imbalance within the last 30 days.
- History of obstructive disease of the gastrointestinal tract including (but not limited to) diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis.
- Scheduled MRI during testing.
- Allergies to adhesives (e.g., medical tape).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2025
First Posted
August 1, 2025
Study Start
October 28, 2024
Primary Completion
May 5, 2025
Study Completion
May 5, 2025
Last Updated
August 1, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share