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

Not Applicable

• Conditions: Physiological Stress
• Interventions: Other: exercise under hot and humid conditions protocol; Device: BC membrane protective garment; Device: NBC mask

• Registration Number: NCT02641535
• Lead Sponsor: Sheba Medical Center

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 Description

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.

Study Timeline

• Status Verified: 2015-12
• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2015-12-28
• Last Update Submitted: 2015-12-28
• Study First Posted: 2015-12-29
• Last Update Posted: 2015-12-29
• Study Start: 2016-02
• Primary Completion: 2017-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
research arm	BC membrane protective garment	12 healthy volunteers from the border guard of the police forces will participate in this study. The subjects will undergo 4 experiment days: 1. Recruitment , medical examination and VO2max test. 2. Acclimatization day by performing moderate exercise protocol under hot and humid climate. 3.2 days of performing moderate exercise under hot and humid conditions protocol, each day dressed with different protective garment: 1. Protective garment in current use + NBC mask. 2. The new BC membrane protective garment + NBC mask
research arm	exercise under hot and humid conditions protocol	12 healthy volunteers from the border guard of the police forces will participate in this study. The subjects will undergo 4 experiment days: 1. Recruitment , medical examination and VO2max test. 2. Acclimatization day by performing moderate exercise protocol under hot and humid climate. 3.2 days of performing moderate exercise under hot and humid conditions protocol, each day dressed with different protective garment: 1. Protective garment in current use + NBC mask. 2. The new BC membrane protective garment + NBC mask
research arm	NBC mask	12 healthy volunteers from the border guard of the police forces will participate in this study. The subjects will undergo 4 experiment days: 1. Recruitment , medical examination and VO2max test. 2. Acclimatization day by performing moderate exercise protocol under hot and humid climate. 3.2 days of performing moderate exercise under hot and humid conditions protocol, each day dressed with different protective garment: 1. Protective garment in current use + NBC mask. 2. The new BC membrane protective garment + NBC mask

Primary Outcome Measures

Name	Time	Method
physiological strain (composite)	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.

Secondary Outcome Measures

Name	Time	Method
Sweat rate (composite)	3 days for each participant	Sweat rate will be calculated from the patients' body weight and fluid balance.
Rectal temperature	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	3 days for each participant	The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
Heart rate	4 days for each participant	The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).

Trial Locations

Locations (1)

Sheba medical center; 🇮🇱 Tel-Hashomer, Ramat- Gan, Israel