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CompletedNCT02463058Updated Dec 24, 2015

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

An interventional study of exercise under hot and humid conditions protocol in Physiological Stress, sponsored by Sheba Medical Center. Completed at 1 site in Israel. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-24.

Sponsored by Sheba Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Male
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Physiological Stress

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03

In context

Heat Stress Disorders

111 studies on the registry are indexed under Heat Stress Disorders; 45 are open to participants now.

This study's enrollment of 10 is below the median of 24 across 97 interventional studies indexed under Heat Stress Disorders.

Browse Heat Stress Disorders studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged 18-40 years.
  • Healthy civilian volunteers.
  • Without known medical illness or medication use.

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Research arm

    10 young and healthy civilian volunteers will participate in this study. The subjects will undergo 5 experiment days: 1. Recruitment , medical examination and VO2max test. 2. Acclimatization day by performing moderate exercise protocol under hot and humid climate. 3. 3 days of performing moderate exercise under hot and humid conditions protocol, each day dressed with different protective garment: 1. Protective garment in current use + NBC mask. 2. The new BC protective undergarment + standard combat uniforms 3. The new BC protective undergarment + standard combat uniforms + NBC mask

    Other: exercise under hot and humid conditions protocol

Interventions

  • Otherexercise under hot and humid conditions protocol

    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.

06

What researchers measure

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).

    Time frame: 4 days for each participant

Secondary outcomes

  1. Rectal temperature

    The rectal temperature will be monitored by a rectal thermistor during each heat tolerance test (HTT).

    Time frame: 4 days for each participant

  2. Skin temperature

    The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).

    Time frame: 4 days for each participant

  3. Heart rate

    The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).

    Time frame: 5 days for each participant

  4. Sweat rate (composite)

    Sweat rate will be calculated from the patients' body weight and fluid balance.

    Time frame: 4 days for each participant

07

Study locations

1 site
  • Sheba medical center
    Tel-Hashomer, Ramat- Gan, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02463058
Lead sponsor
Sheba Medical Center
Responsible party
Sponsor
First posted
Jun 4, 2015
Start date
Aug 2015
Primary completion
Nov 2015
Completion
Dec 2015
Last update
Dec 24, 2015

Study contacts

Ofir Frenkel, M.D
principal investigator · Sheba Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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