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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Sheba Medical Center

Current Primary Outcome: physiological strain (composite) [ Time Frame: 4 days for each participant ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rectal temperature [ Time Frame: 4 days for each participant ]
    The rectal temperature will be monitored by a rectal thermistor during each heat tolerance test (HTT).
  • Skin temperature [ Time Frame: 4 days for each participant ]
    The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
  • Heart rate [ Time Frame: 5 days for each participant ]
    The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
  • Sweat rate (composite) [ Time Frame: 4 days for each participant ]
    Sweat rate will be calculated from the patients' body weight and fluid balance.


Original Secondary Outcome: Same as current

Information By: Sheba Medical Center

Dates:
Date Received: June 2, 2015
Date Started: August 2015
Date Completion:
Last Updated: December 23, 2015
Last Verified: December 2015