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

Physiological Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02463058
• Other study ID #: SHEBA-15-2235-OF-CTIL
• Status: Completed
• Phase: N/A
• First received: June 2, 2015
• Last updated: December 23, 2015
• Start date: August 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Physiological Stress

Intervention

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 (3 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 (30 deg. centigrade & 60% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously.

Locations

Country	Name	City	State
Israel	Sheba medical center	Tel-Hashomer	Ramat- Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physiological strain (composite)	The physiological strain will be determined by body core temperature and heart rate of the subjects during a heat tolerance test (HTT).	4 days for each participant	No
Secondary	Rectal temperature	The rectal temperature will be monitored by a rectal thermistor during each heat tolerance test (HTT).	4 days for each participant	Yes
Secondary	Skin temperature	The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).	4 days for each participant	No
Secondary	Heart rate	The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).	5 days for each participant	Yes
Secondary	Sweat rate (composite)	Sweat rate will be calculated from the patients' body weight and fluid balance.	4 days for each participant	No