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

Body Temperature Changes Clinical Trial

Official title:

The Effect of Ventilated Vest on Thermoregulation During Exercise in Hot

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01863927
• Other study ID #: SHEBA-12-9726-AD-CTIL
• Secondary ID: 1178-12
• Status: Not yet recruiting
• Phase: N/A
• First received: May 23, 2013
• Last updated: May 7, 2014
• Start date: November 2014
• Est. completion date: February 2016

Study information

• Verified date: May 2014
• Source: Sheba Medical Center
• Contact: Barliz Adato, MD
• Phone: +972542662201
• Email: Barliz.Adato[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: February 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 28 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Body Temperature Changes

Intervention

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)

Locations

Country	Name	City	State
Israel	Sheba medical center	Tel-Hashomer, Ramat- Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes