Acute Exercise With Overdressing
Acute-XO
Efficacy of a Novel Exercise + Overdressing Protocol to Induce Targeted Heat Stress in Temperate Environments (Acute XO-Study)
1 other identifier
interventional
23
1 country
1
Brief 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.
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 Jun 2023
Typical duration 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
June 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2025
CompletedFirst Submitted
Initial submission to the registry
July 2, 2025
CompletedFirst Posted
Study publicly available on registry
July 23, 2025
CompletedDecember 24, 2025
December 1, 2025
1.9 years
July 2, 2025
December 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Core temperature
Core temperature during exercise
Up to 90 minutes
Heart Rate
Heart rate during exercise
Up to 90 minutes
Skin temperature
Mean-weighted skin temperature during exercise
Up to 90 minutes
Whole-body sweat loss
90 minutes
Study Arms (2)
Exercise with Overdressing
EXPERIMENTALExercise with overdressing clothing ensemble
Control Exercise
ACTIVE COMPARATORExercise with normal attire
Interventions
Run for 30 minutes followed by walk for 60 minutes in a temperate (gym-like environment) wearing overdressing ensemble.
Run for 30 minutes followed by walk for 60 minutes in a temperate (gym-like environment) wearing control clothing ensemble.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Any history of asthma
- Current or recent respiratory tract or sinus infections (\< 1 month prior)
- History of heat intolerance 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin J Ryan, PhD
United States Army Research Institute of Environmental Medicine
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
July 2, 2025
First Posted
July 23, 2025
Study Start
June 22, 2023
Primary Completion
April 28, 2025
Study Completion
April 28, 2025
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share