Examination of Textile Solutions for Reducing Physiological Stress

Physiological Stress Clinical Trial

Official title:

Physiological Examination of Textile Solutions for Stress Reduction When Dressed in Protective Garment and Work Clothes and Under Physical and Heat Stress Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442947
• Other study ID #: SHEBA-14-1853-YH-CTIL
• Status: Completed
• Phase: N/A
• First received: April 29, 2015
• Last updated: December 23, 2015
• Start date: June 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Physiological Stress

Intervention

Other:
• 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.

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).	10 days for each participant	No
Secondary	Rectal temperature	The rectal temperature will be monitored by a rectal thermistor during each heat tolerance test (HTT).	10 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).	10 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).	10 days for each participant	Yes
Secondary	Sweat rate (composite)	Sweat rate will be calculated from the patients' body weight and fluid balance.	10 days for each participant	No