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

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.

Study Overview

• Status: Unknown
• Conditions: Physiological Stress
• Intervention / Treatment: Other: exercise under hot and humid conditions protocol; Device: BC membrane protective garment; Device: NBC mask

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 Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat- Gan
    • Tel-Hashomer, Ramat- Gan, Israel
      • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: research arm; 12 healthy volunteers from the border guard of the police forces will participate in this study. The subjects will undergo 4 experiment days: Recruitment , medical examination and VO2max test.; 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: Protective garment in current use + NBC mask.; The new BC membrane protective garment + NBC mask

Other: exercise under hot and humid conditions protocol; 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 (2 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 (35 deg. centigrade & 60% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously.; Device: BC membrane protective garment; Device: NBC mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physiological strain (composite)	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.	3 days for each participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rectal temperature	The rectal temperature will be monitored by a rectal thermistor (YSI-401) inserted 10 cm past the anal sphincter.	3 days for each participant
Skin temperature	The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).	3 days for each participant
Heart rate	The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).	4 days for each participant
Sweat rate (composite)	Sweat rate will be calculated from the patients' body weight and fluid balance.	3 days for each participant

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: December 23, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Estimate): December 29, 2015
• Last Update Submitted That Met QC Criteria: December 28, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Heat Stress Disorders
• Other Study ID Numbers: SHEBA-15-2689-OF-CTIL