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NCT Number: NCT02442947

Examination of Textile Solutions for Reducing Physiological Stress

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.

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Key information

Conditions

Physiological Stress

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sheba medical center

Tel Litwinsky, Ramat- Gan, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 13, 2015
Registry last updated
Dec 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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