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NCT Number: NCT02463058

Evaluating the Physiological Strain Induced by a BC Protective Undergarment Under Exercise-heat Stress

Israel ministry of defense is examining a new protective undergarment of GORE company (chempark fabric) for the police forces. The goal of this research is to perform a comparative experiment in order to evaluate the physiological strain induced by a BC protective undergarment under exercise-heat stress conditions.

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Key information

Conditions

Physiological Stress

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sheba medical center

Tel Litwinsky, Ramat- Gan, Israel

About this study

In order to physiologically evaluate a new BC protective garment for the Israeli police use under exercise-heat stress conditions, 10 young and healthy civilian volunteers will participate in this study.

The subjects will undergo 5 experiment days: Recruitment day, one day of acclimatization to heat, and 3 days of performing experiment protocol, each day dressed with different protective garment (Protective garment in current use + NBC mask, new BC protective undergarment + standard combat uniforms, new BC protective undergarment + standard combat uniforms + NBC mask).

Core (rectal) and skin temperature and heart rate will be monitored continuously, liquid balance will be recorded.the physiological heat strain will be assessed and compared between the different protective garments.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18-40 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 skeleton 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

exercise under hot and humid conditions protocol

Other

acclimatization day protocol: 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% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously

experiment days (3 days): 2 hour effort (2 cycles of: 50 min walk and 10 min rest-sitting) performed in a climatic chamber, which include walk on a treadmill at 5 Km/h on a 2% incline under heat conditions (30 deg. centigrade & 60% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously.

Primary outcomes

  1. physiological strain (composite)

    Time frame: 4 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: 4 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: 4 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: 5 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: 4 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 4, 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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