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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02641535
Enrollment
12
Registered
2015-12-29
Start date
2016-02-29
Completion date
2017-02-28
Last updated
2015-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physiological Stress

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.

Interventions

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.

DEVICEBC membrane protective garment
DEVICENBC mask

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
physiological strain (composite)3 days for each participantThe 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

MeasureTime frameDescription
Rectal temperature3 days for each participantThe rectal temperature will be monitored by a rectal thermistor (YSI-401) inserted 10 cm past the anal sphincter.
Skin temperature3 days for each participantThe skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
Heart rate4 days for each participantThe heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
Sweat rate (composite)3 days for each participantSweat rate will be calculated from the patients' body weight and fluid balance.

Countries

Israel

Contacts

Primary ContactOfir Frenkel, M.D
Ofir.Frenkel@sheba.health.gov.il+972529243399

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026