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Completed

NCT Number: NCT07080853

Acute Exercise With Overdressing

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

US Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

About this study

The purpose of the present study is to examine the influence of a novel 90-minute exercise + overdressing protocol on thermal responses in comparison to matched exercise in standard PT clothing. Sixteen healthy and fit adults (8 men and 8 women) will complete two 90-minute exercise sessions (randomized order) in a temperate environment (~20°C, ~50% relative humidity, and ~1 mph air velocity) involving a 30-minute run immediately followed by a 60-minute walk. Participants will wear standard physical training (PT) clothing (shorts, t-shirt) during one session and an overdressing ensemble in the other. The investigators hypothesize that 1) exercise + overdressing will elevate core temperature to between 38.3°C and 39.3°C for at least 45 minutes; and 2) elevations in core temperature, skin temperature, heart rate, and sweat rate will be substantially larger than observed with 90 minutes of matched exercise in standard PT clothing.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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).

Treatment and study plan

Exercise with Overdressing

Other

Run for 30 minutes followed by walk for 60 minutes in a temperate (gym-like environment) wearing overdressing ensemble.

Control Exercise

Other

Run for 30 minutes followed by walk for 60 minutes in a temperate (gym-like environment) wearing control clothing ensemble.

Primary outcomes

  1. Core temperature

    Time frame: Up to 90 minutes

    Core temperature during exercise

  2. Heart Rate

    Time frame: Up to 90 minutes

    Heart rate during exercise

  3. Skin temperature

    Time frame: Up to 90 minutes

    Mean-weighted skin temperature during exercise

  4. Whole-body sweat loss

    Time frame: 90 minutes

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Registry information

Official study title

Efficacy of a Novel Exercise + Overdressing Protocol to Induce Targeted Heat Stress in Temperate Environments (Acute XO-Study)

Acronym: Acute-XO

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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