The Effect of Ventilated Vest on Thermoregulation During Exercise in Hot Environment

The Effect of Ventilated Vest on Thermoregulation During Exercise in Hot

The purpose of this preliminary experiment is to measure the effect of a novel ventilation system on the physiological strain during exercise in high heat load while wearing ballistic protective vest. Ten young and healthy participants will participate in the study. They will all go through a six days heat acclimation period in a heat chamber according to a valid protocol. Afterwards they will be randomly exposed to 4 conditions during four separate consecutive days.

Study Overview

• Status: Unknown
• Conditions: Body Temperature Changes
• Intervention / Treatment: Other: Research intervention

Detailed Description

Ten young and healthy civilian participants will participate in the study. They will all go through a six days heat acclimation period in a heat chamber according to a valid protocol. After heat acclimation the participant will be randomly exposed to 4 conditions during four separate consecutive days: 1) walking on a treadmill for two hours in hot-wet conditions (30OC, 70% RH) while wearing military uniforms and a vest (control group); 2) walking on a treadmill for two hours in hot-dry conditions (40OC, 30% RH) while wearing military uniforms and a vest (control group); 3) walking on a treadmill for two hours in hot-wet conditions (30OC, 70% RH) while wearing military uniforms and a vest with a ventilator (experimental group); 4) walking on a treadmill for two hours in hot-dry conditions (40OC, 30% RH) while wearing military uniforms and a vest with a ventilator (experimental group). During the heat exposures, rectal temperature, skin temperature and heart rate will be continuously monitored. Subjective comfort measures, heat strain indices, sweat rate and sweat evaporation will be also measured/calculated. The differences in the above measures, during exposure to exercise in the heat between ventilator and no ventilator will be then analyzed.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel-Hashomer, Ramat- Gan, Israel
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• age 21-28
• healthy
• after medical checkup
• after signing concent form

Exclusion Criteria:

• heart disease
• respiratory disease
• baseline bp above 140/90 mmHg
• sleep disorders
• diabetes
• anhydrosis
• skin disease
• acute illness in last 3 days prior to the examination

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Research arm; Each of the participants will be randomly exposed to 4 conditions during four separate consecutive days.

Other: Research intervention; After heat acclimation the participant will be randomly exposed to 4 conditions during four separate consecutive days: 1) walking on a treadmill for two hours in hot-wet conditions (30OC, 70% RH) while wearing military uniforms and a vest (control group); 2) walking on a treadmill for two hours in hot-dry conditions (40OC, 30% RH) while wearing military uniforms and a vest (control group); 3) walking on a treadmill for two hours in hot-wet conditions (30OC, 70% RH) while wearing military uniforms and a vest with a ventilator (experimental group); 4) walking on a treadmill for two hours in hot-dry conditions (40OC, 30% RH) while wearing military uniforms and a vest with a ventilator (experimental group); Other Names: Heat exposure, exercise in hot environment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heat tolerance test	The test is performed in a climatic chamber at a temperature of 40oC and 40% relative humidity. During the test, the subject walks on a treadmill at a speed of 5 km/hr at a 2% grade for 2h. Body core temperature and heart rate are continuously monitored, and sweat rate is computed from body weight prior to and after the test, corrected for fluid intake. Heat intolerance is determined when body core temperature elevates above 38.5oC, when heart rate elevates above 150 bpm, or when either does not tend to reach a plateau.	1 year
Maximal oxygen consumption test	Volunteer's oxygen consumption (VO2) will be monitored continuously with a metabolic chart (ZAN), while running for 10 min on a treadmill under comfortable environmental conditions.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin temperature	The volunteers will undergo heat tolerance test. Their skin temperature will be measured by skin thermistors and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system.	1 year
Rectal temperature	The volunteers will undergo heat tolerance test. Their rectal temperature will be measured by rectal thermistor and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system.	1 year
Heart rate	During the HTT and the VO2 test heart rates will be monitored continuously and will be stored by a heart rate wristwatch, (POLAR, Finland).	1 year

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Barliz Adato, MD, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: May 23, 2013
• First Submitted That Met QC Criteria: May 23, 2013
• First Posted (Estimate): May 29, 2013

Study Record Updates

• Last Update Posted (Estimate): May 8, 2014
• Last Update Submitted That Met QC Criteria: May 7, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: SHEBA-12-9726-AD-CTIL; 1178-12 (Other Identifier: IDF)