Chronic Exercise With Overdressing | NCT07099872

NCT07099872

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Control	Other	Wear normal attire (shorts/t-shirt) during exercise sessions in a gym-like environment.	Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Urine Specific Gravity	Urine specific gravity prior to heat stress test	Through study completion, an average of 8 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).