The Effect of Ventilated Vest on Thermoregulation During Exercise in Hot Environment
Primary Purpose
Body Temperature Changes
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Research intervention
Sponsored by
About this trial
This is an interventional basic science trial for Body Temperature Changes
Eligibility Criteria
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
Sites / Locations
- Sheba medical center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Research arm
Arm Description
Each of the participants will be randomly exposed to 4 conditions during four separate consecutive days.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01863927
Brief Title
The Effect of Ventilated Vest on Thermoregulation During Exercise in Hot Environment
Official Title
The Effect of Ventilated Vest on Thermoregulation During Exercise in Hot
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Temperature Changes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Research arm
Arm Type
Experimental
Arm Description
Each of the participants will be randomly exposed to 4 conditions during four separate consecutive days.
Intervention Type
Other
Intervention Name(s)
Research intervention
Other Intervention Name(s)
Heat exposure, exercise in hot environment
Intervention Description
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)
Primary Outcome Measure Information:
Title
Heat tolerance test
Description
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.
Time Frame
1 year
Title
Maximal oxygen consumption test
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Skin temperature
Description
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.
Time Frame
1 year
Title
Rectal temperature
Description
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.
Time Frame
1 year
Title
Heart rate
Description
During the HTT and the VO2 test heart rates will be monitored continuously and will be stored by a heart rate wristwatch, (POLAR, Finland).
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barliz Adato, MD
Phone
+972542662201
Email
Barliz.Adato@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barliz Adato, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba medical center
City
Tel-Hashomer, Ramat- Gan
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barliz Adato, MD
Email
Barliz.Adato@sheba.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
The Effect of Ventilated Vest on Thermoregulation During Exercise in Hot Environment
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