NCT07080853

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

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

July 2, 2025

Last Update Submit

December 17, 2025

Conditions

Keywords

Heat acclimationOverdressing

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

EXPERIMENTAL

Exercise with overdressing clothing ensemble

Other: Exercise with Overdressing

Control Exercise

ACTIVE COMPARATOR

Exercise with normal attire

Other: Control Exercise

Interventions

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

Exercise with Overdressing

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

Control Exercise

Eligibility Criteria

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

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

Location

MeSH Terms

Conditions

Heat Stress Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Benjamin J Ryan, PhD

    United States Army Research Institute of Environmental Medicine

    PRINCIPAL INVESTIGATOR

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

Locations