Examination of Textile Solutions for Reducing Physiological Stress

NCT ID: NCT02442947

Last Updated: 2015-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-12-31

Brief Summary

Using protective or combat garments under heavy heat stress conditions, during rest or exertion, may hinder the body's ability to effectively exchange heat with the environment and thereby can lead to heat injuries. The purpose of this research is to physiologically examine the new textile solutions that are planned to be integrated in the protective garments, combat garments and work uniforms in the army, by evaluating the physiological stress obtained during exertion under hot climatic conditions.

Detailed Description

10 young, healthy civilian volunteers will participate in this study. After reading and signing an informed consent form, all subjects will undergo medical examination which includes ECG, anthropometric measurements and Vo2max test. Afterwards, the subjects will perform 6 acclimatization days carried out by the standard protocol of Heat Tolerance Test (HTT). After acclimatization, the subjects will undergo 4 experiment days under heavy heat stress in a climatic chamber, dressed in each experiment day with one out of 4 clothing combinations (NBC protective garment [charcoal base], combat garment and 2 different types of work uniforms). Physiological stress will be evaluated from rectal temperature and heart rate measurements.

Conditions

Physiological Stress

Keywords

stress when dressed; protective garment; work clothes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Research arm

1. 1 day which will include: physician examination,ECG,anthropometric measurements and Vo2max test.

2. 6 acclimatization days carried out by a standard protocol including a daily 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% HR) and when dressed in shorts.At the sixth day, the subjects will be dressed in a standard work uniform as a baseline exposure. Core (rectal) and skin temperature and heart rate will be monitored continuously.

3. 4 experiment days carried out by the following protocol: 2 hour walk on a treadmill (5 Km/h,2% incline) under heavy heat stress conditions (30 deg. centigrade,60% RH) and when dressed each time with different clothing out of 4 options:

1. NBC protective garment (charcoal base).

2. combat garment.

3. 2 different types of work uniforms. physiological stress will be examined based on rectal temperature and heart rate measurements.

Group Type: EXPERIMENTAL

clothing type, protective garments of Paul Boye Technologies

Intervention Type: OTHER

The experiment aimed at evaluating the physiological stress obtained when dressed in different clothing (NBC protective garment \[charcoal base\], combat garment and 2 different types of work uniforms- (1)50% cotton and 50% polyester (2)80% cotton and 20% polyester) and during exertion under heat conditions.

Interventions

clothing type, protective garments of Paul Boye Technologies

The experiment aimed at evaluating the physiological stress obtained when dressed in different clothing (NBC protective garment \[charcoal base\], combat garment and 2 different types of work uniforms- (1)50% cotton and 50% polyester (2)80% cotton and 20% polyester) and during exertion under heat conditions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged 18-30 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 skeledon condition.
• Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.
• Infectious disease 3 days prior to the experiment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ofir Frenkel, M.D

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba medical center

Tel Litwinsky, Ramat- Gan, Israel

Countries

Israel

Other Identifiers

SHEBA-14-1853-YH-CTIL

Identifier Type: -

Identifier Source: org_study_id