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Evaluating the Physiological Strain Induced by a BC Protective Undergarment Under Exercise-heat Stress

Primary Purpose

Physiological Stress

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
exercise under hot and humid conditions protocol
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physiological Stress

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 18-40 years.
  • Healthy civilian volunteers.
  • Without known medical illness or medication use.

Exclusion Criteria:

  • The existence or suspicion of existing cardiac or respiratory disease.
  • Hypertension.
  • Diabetes.
  • Psychiatric condition.
  • Any muscles or skeleton condition.
  • Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.
  • Infectious disease 3 days prior to the experiment.

Sites / Locations

  • Sheba medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Research arm

Arm Description

10 young and healthy civilian volunteers will participate in this study. The subjects will undergo 5 experiment days: Recruitment , medical examination and VO2max test. Acclimatization day by performing moderate exercise protocol under hot and humid climate. 3 days of performing moderate exercise under hot and humid conditions protocol, each day dressed with different protective garment: Protective garment in current use + NBC mask. The new BC protective undergarment + standard combat uniforms The new BC protective undergarment + standard combat uniforms + NBC mask

Outcomes

Primary Outcome Measures

physiological strain (composite)
The physiological strain will be determined by body core temperature and heart rate of the subjects during a heat tolerance test (HTT).

Secondary Outcome Measures

Rectal temperature
The rectal temperature will be monitored by a rectal thermistor during each heat tolerance test (HTT).
Skin temperature
The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
Heart rate
The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
Sweat rate (composite)
Sweat rate will be calculated from the patients' body weight and fluid balance.

Full Information

First Posted
June 2, 2015
Last Updated
December 23, 2015
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02463058
Brief Title
Evaluating the Physiological Strain Induced by a BC Protective Undergarment Under Exercise-heat Stress
Official Title
Evaluating the Physiological Strain Induced by a BC Protective Undergarment Under Exercise-heat Stress
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Israel ministry of defense is examining a new protective undergarment of GORE company (chempark fabric) for the police forces. The goal of this research is to perform a comparative experiment in order to evaluate the physiological strain induced by a BC protective undergarment under exercise-heat stress conditions.
Detailed Description
In order to physiologically evaluate a new BC protective garment for the Israeli police use under exercise-heat stress conditions, 10 young and healthy civilian volunteers will participate in this study. The subjects will undergo 5 experiment days: Recruitment day, one day of acclimatization to heat, and 3 days of performing experiment protocol, each day dressed with different protective garment (Protective garment in current use + NBC mask, new BC protective undergarment + standard combat uniforms, new BC protective undergarment + standard combat uniforms + NBC mask). Core (rectal) and skin temperature and heart rate will be monitored continuously, liquid balance will be recorded.the physiological heat strain will be assessed and compared between the different protective garments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physiological Stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Research arm
Arm Type
Experimental
Arm Description
10 young and healthy civilian volunteers will participate in this study. The subjects will undergo 5 experiment days: Recruitment , medical examination and VO2max test. Acclimatization day by performing moderate exercise protocol under hot and humid climate. 3 days of performing moderate exercise under hot and humid conditions protocol, each day dressed with different protective garment: Protective garment in current use + NBC mask. The new BC protective undergarment + standard combat uniforms The new BC protective undergarment + standard combat uniforms + NBC mask
Intervention Type
Other
Intervention Name(s)
exercise under hot and humid conditions protocol
Intervention Description
acclimatization day protocol: 2 hour effort performed in a climatic chamber, which include walk on a treadmill at 5 Km/h on a 2% incline under heat conditions (40 deg. centigrade & 40% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously experiment days (3 days): 2 hour effort (2 cycles of: 50 min walk and 10 min rest-sitting) performed in a climatic chamber, which include walk on a treadmill at 5 Km/h on a 2% incline under heat conditions (30 deg. centigrade & 60% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously.
Primary Outcome Measure Information:
Title
physiological strain (composite)
Description
The physiological strain will be determined by body core temperature and heart rate of the subjects during a heat tolerance test (HTT).
Time Frame
4 days for each participant
Secondary Outcome Measure Information:
Title
Rectal temperature
Description
The rectal temperature will be monitored by a rectal thermistor during each heat tolerance test (HTT).
Time Frame
4 days for each participant
Title
Skin temperature
Description
The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
Time Frame
4 days for each participant
Title
Heart rate
Description
The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
Time Frame
5 days for each participant
Title
Sweat rate (composite)
Description
Sweat rate will be calculated from the patients' body weight and fluid balance.
Time Frame
4 days for each participant

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18-40 years. Healthy civilian volunteers. Without known medical illness or medication use. Exclusion Criteria: The existence or suspicion of existing cardiac or respiratory disease. Hypertension. Diabetes. Psychiatric condition. Any muscles or skeleton condition. Any hormonal disease or any other chronic illness that may inhibit participation in the experiment. Infectious disease 3 days prior to the experiment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofir Frenkel, M.D
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba medical center
City
Tel-Hashomer
State/Province
Ramat- Gan
Country
Israel

12. IPD Sharing Statement

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Evaluating the Physiological Strain Induced by a BC Protective Undergarment Under Exercise-heat Stress

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