Examination of Textile Solutions for Reducing Physiological Stress

NCT02442947 | Completed

• 1 other identifier: SHEBA-14-1853-YH-CTIL
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Physiological Stress

Keywords

stress when dressed; protective garment; work clothes

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).

  10 days for each participant

Secondary Outcomes (4)

• Rectal temperature

  10 days for each participant

• Skin temperature

  10 days for each participant

• Heart rate

  10 days for each participant

• Sweat rate (composite)

  10 days for each participant

Study Arms (1)

Research arm

EXPERIMENTAL

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.

Other: clothing type, protective garments of Paul Boye Technologies

Interventions

clothing type, protective garments of Paul Boye Technologies 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.

Research arm

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-30 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 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.

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: April 29, 2015
• First Posted: May 13, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

IL (1)