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Examination of Textile Solutions for Reducing Physiological Stress

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ClinicalTrials.gov Identifier: NCT02442947
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Physiological Stress Other: clothing type, protective garments of Paul Boye Technologies Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : June 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heat Illness

Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. physiological strain (composite) [ Time Frame: 10 days for each participant ]
    The physiological strain will be determined by body core temperature and heart rate of the subjects during a heat tolerance test (HTT).


Secondary Outcome Measures :
  1. Rectal temperature [ Time Frame: 10 days for each participant ]
    The rectal temperature will be monitored by a rectal thermistor during each heat tolerance test (HTT).

  2. Skin temperature [ Time Frame: 10 days for each participant ]
    The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).

  3. Heart rate [ Time Frame: 10 days for each participant ]
    The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).

  4. Sweat rate (composite) [ Time Frame: 10 days for each participant ]
    Sweat rate will be calculated from the patients' body weight and fluid balance.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442947


Locations
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Israel
Sheba medical center
Tel-Hashomer, Ramat- Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Ofir Frenkel, M.D Sheba Medical Center

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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02442947     History of Changes
Other Study ID Numbers: SHEBA-14-1853-YH-CTIL
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: December 2015
Keywords provided by Sheba Medical Center:
stress when dressed
protective garment
work clothes