NCT07099872

Brief Summary

The purpose of this study is to determine if five training sessions of exercise with overdressing can induce heat acclimation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

June 26, 2025

Last Update Submit

July 29, 2025

Conditions

Keywords

Heat AcclimationHeat Stress Test

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

EXPERIMENTAL

5 days of standardized exercise with overdressing

Other: Overdressing

Exercise

ACTIVE COMPARATOR

5 days of standardized exercise wearing PT clothing

Other: Control

Interventions

ControlOTHER

Wear normal attire (shorts/t-shirt) during exercise sessions in a gym-like environment.

Exercise

Wear standardized overdressing ensemble during exercise sessions in a gym-like environment.

Exercise with Overdressing

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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

Locations