Clinical Trial: Evaluating the Physiological Strain Induced by a BC Membrane Protective Garment Under Exercise-heat Stress Compared to a Protective Coverall

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Evaluating the Physiological Strain Induced by a BC Membrane Protective Garment Under Exercise-heat Stress Compared to a Protective Coverall

Brief Summary: Israel ministry of defense is examining a new BC membrane protective garment of BLAUER company constructed with GORE CHEMPAK fabric for the border guard of the police forces. The goal of this research is to perform a comparative experiment in order to evaluate the physiological strain induced by the new protective garment under exercise-heat stress conditions, compared to protective garment in current use.

Detailed Summary:

In order to physiologically evaluate a new BC membrane protective garment for the Israeli police use under exercise-heat stress conditions, 12 healthy volunteers from the border guard will participate in this study.

The subjects will undergo 4 experiment days: Recruitment day, one day of acclimatization to heat, and 2 days of performing experiment protocol, each day dressed with different protective garment (Protective garment in current use + NBC mask, new BC membrane protective garment + 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: 3 days for each participant ]

The physiological strain will be determined by body core temperature and heart rate of the subjects during experiment days with protocol of exercise under heat stress conditions.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rectal temperature [ Time Frame: 3 days for each participant ]
    The rectal temperature will be monitored by a rectal thermistor (YSI-401) inserted 10 cm past the anal sphincter.
  • Skin temperature [ Time Frame: 3 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: 4 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: 3 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: December 23, 2015
Date Started: February 2016
Date Completion: February 2017
Last Updated: December 28, 2015
Last Verified: December 2015