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LBNP Tolerance With Skin Warming After Exercise Cold Stress

Skin Rewarming After Exercise Cold Stress and Tolerance to Simulated Blood Loss

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06279897
Enrollment
10
Registered
2024-02-28
Start date
2022-01-24
Completion date
2026-09-30
Last updated
2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss, Blood Pressure

Keywords

Arterial Blood Pressure, Permissive Hypotension, Cold Stress, Skin Warming, Blood Loss

Brief summary

Assess the effect of skin rewarming during lower body negative pressure upon arterial blood pressure and tolerance to simulated blood loss after exercise in the cold.

Detailed description

Individuals who have experienced a hemorrhagic insult are often wrapped in a warm blanket. In individuals who have exercise in a cold environment, it is unknown how this skin warming influence tolerance to simulated blood loss and whether there is an optimal temperature to warm the skin up to in order to lower blood pressure (permissive hypotension). After an initial study visit to examine exercise capacity (Visit 1), participants will complete four trials (Visits 2 through 5) After exercise in a cold environment, participants will have cold skin temperatures (\ 82°F; Visit 2). Researchers will examine how increasing skin temperature to normal (\ 90°F; Visit 3), warm (93°F; Visit 4) and hot (95°F; Visit 5) influences arterial blood pressure and tolerance to simulated blood loss compared to when the skin remains cold. This project will test the hypothesis that skin rewarming to \ 95°F lowers arterial blood pressure without impairing tolerance to simulated blood loss (lower body negative pressure; LBNP) relative to when the skin is kept cold (82°F). Primary data include core and skin temperatures, arterial blood pressure and LBNP tolerance time. Secondary variables include skin blood flow and heart rate. After completing visit 1 first, all participants will complete visits 2 through 5 in a randomized order and participants are blinded. The order will be counterbalanced between participants.

Interventions

OTHERSkin Surface Rewarming

Sixty seconds after the onset of lower body negative pressure (LBNP) skin temperature will be increased to \ 90°F and held here for the duration of the LBNP test.

OTHERSkin Surface Warming

Sixty seconds after the onset of lower body negative pressure (LBNP) skin temperature will be increased to \ 93°F and held here for the duration of the LBNP test.

OTHERSkin Surface Heating

Sixty seconds after the onset of lower body negative pressure (LBNP) skin temperature will be increased to \ 95°F and held here for the duration of the LBNP test.

OTHERSkin Surface Cooling

Sixty seconds after the onset of lower body negative pressure (LBNP) skin temperature will remain lowered to \ 82°F for the duration of the LBNP test.

Sponsors

University of Colorado, Colorado Springs
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

Participants are blinded to the skin temperature control.

Intervention model description

Participants will complete trial 1 at the beginning of the study. Participants will then complete trials 2 through 5 in a random, counterbalanced order.

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 18 and 40 years old * free of known disease and illness * Speak English * Systolic blood pressure \<140mmHg * Diastolic blood pressure \<90 mmHg

Exclusion criteria

* Currently pregnant or breast feeding * Individuals with diagnosed with cardiac, respiratory, neurological and/or metabolic illness or disease. * Currently taking prescribed or over the counter medications known to influence the cardiovascular, pulmonary, renal and/or central nervous system. * Current use of tobacco or nicotine products * Any physical limitations that impede completion of the tests, such as exercise tests will also be an

Design outcomes

Primary

MeasureTime frameDescription
Arterial blood pressureBefore and during lower body negative pressure (LBNP) procedureDuring simulated blood loss is the reduction in arterial blood pressure greater with progressive skin heating
Tolerance to simulated blood lossLower body negative pressure test duration in all trials.Tolerance to LBNP will be quantified using the cumulative stress index (CSI) calculated by summing the time at each level of LBNP multiplied by that level (i.e., 20 mmHg \* 3 min + 30 mmHg \* 3 min + 40 mmHg \* 3 min, etc.) until test termination.

Secondary

MeasureTime frameDescription
Core temperatureThroughout exercise cold exposure and continuously during LBNPMeasured using rectal probe or intestinal pill and indicative of change in internal body temperature.
Cutaneous Vascular ConductanceBefore and during lower body negative pressure (LBNP) procedureSkin blood flow measured using laser Doppler flowmetry (AU) will be referenced relative to arterial blood pressure (mmHg) and expressed as cutaneous vascular conductance (CVC; AU/mmHg)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026