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

NCT02463058 | Completed

• 1 other identifier: SHEBA-15-2235-OF-CTIL
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physiological Stress

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Rectal temperature

  4 days for each participant

• Skin temperature

  4 days for each participant

• Heart rate

  5 days for each participant

• Sweat rate (composite)

  4 days for each participant

Study Arms (1)

Research arm

EXPERIMENTAL

10 young and healthy civilian volunteers will participate in this study. The subjects will undergo 5 experiment days: 1. Recruitment , medical examination and VO2max test. 2. Acclimatization day by performing moderate exercise protocol under hot and humid climate. 3. 3 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 protective undergarment + standard combat uniforms 3. The new BC protective undergarment + standard combat uniforms + NBC mask

Other: exercise under hot and humid conditions protocol

Interventions

exercise under hot and humid conditions protocol OTHER

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.

Research arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-40 years.
• Healthy civilian volunteers.
• Without known medical illness or medication use.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center

Tel Litwinsky, Ramat- Gan, Israel

Location

Study Officials

• Ofir Frenkel, M.D

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 4, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

IL (1)