LBNP Tolerance With Skin Warming After Exercise Cold Stress

NCT06279897 | Active Not Recruiting

• 1 other identifier: 2023-068
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Blood Loss

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Arterial blood pressure

  During simulated blood loss is the reduction in arterial blood pressure greater with progressive skin heating

  Before and during lower body negative pressure (LBNP) procedure

• Tolerance to simulated blood loss

  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.

  Lower body negative pressure test duration in all trials.

Secondary Outcomes (2)

• Core temperature

  Throughout exercise cold exposure and continuously during LBNP

• Cutaneous Vascular Conductance

  Before and during lower body negative pressure (LBNP) procedure

Study Arms (1)

Skin Temperature Control During Simulated Blood Loss After Exercise Cold Stress

EXPERIMENTAL

After exercise in the cold and participants skin will remain cold (\~82°F), be returned to normal (\~90°F), be slightly warmed (\~93°F) or heated (\~95°F) sixty seconds after the onset of LBNP.

Other: Skin Surface Rewarming; Other: Skin Surface Warming; Other: Skin Surface Heating; Other: Skin Surface Cooling

Interventions

Skin Surface Rewarming OTHER

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.

Also known as: Normothermic Trial

Skin Temperature Control During Simulated Blood Loss After Exercise Cold Stress

Skin Surface Warming OTHER

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.

Also known as: Warm Trial

Skin Temperature Control During Simulated Blood Loss After Exercise Cold Stress

Skin Surface Heating OTHER

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.

Also known as: Hot Trial

Skin Temperature Control During Simulated Blood Loss After Exercise Cold Stress

Skin Surface Cooling OTHER

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.

Also known as: Cold Trial, Control Trial

Skin Temperature Control During Simulated Blood Loss After Exercise Cold Stress

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• Body mass\< 80 pounds body weight
• Appendectomy

Sponsors & Collaborators

• University of Colorado, Colorado Springs: lead

Study Sites (1)

University of Colorado Colorado Springs

Colorado Springs, Colorado, 80918, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James Pearson, PhD

  Univeristy of Colorado Colorado Springs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants are blinded to the skin temperature control.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 28, 2024
• Study Start: January 24, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data may be requested up to 36 months following article publication.
• Access Criteria: Data will be made available upon reasonable request. Requests should be directed to jpearso5@uccs.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)