NCT02641535

Brief Summary

Israel ministry of defense is examining a new BC membrane protective garment of BLAUER company constructed with GORE CHEMPAK fabric for the border guard of the police forces. The goal of this research is to perform a comparative experiment in order to evaluate the physiological strain induced by the new protective garment under exercise-heat stress conditions, compared to protective garment in current use.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

December 29, 2015

Status Verified

December 1, 2015

Enrollment Period

1 year

First QC Date

December 23, 2015

Last Update Submit

December 28, 2015

Conditions

Physiological Stress

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 experiment days with protocol of exercise under heat stress conditions.

    3 days for each participant

Secondary Outcomes (4)

  • Rectal temperature

    3 days for each participant

  • Skin temperature

    3 days for each participant

  • Heart rate

    4 days for each participant

  • Sweat rate (composite)

    3 days for each participant

Study Arms (1)

research arm

EXPERIMENTAL

12 healthy volunteers from the border guard of the police forces will participate in this study. The subjects will undergo 4 experiment days: 1. Recruitment , medical examination and VO2max test. 2. Acclimatization day by performing moderate exercise protocol under hot and humid climate. 3.2 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 membrane protective garment + NBC mask

Other: exercise under hot and humid conditions protocolDevice: BC membrane protective garmentDevice: NBC mask

Interventions

exercise under hot and humid conditions protocolOTHER

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 (2 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 (35 deg. centigrade \& 60% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously.

research arm
BC membrane protective garmentDEVICE
research arm
NBC maskDEVICE
research arm

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-40 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba medical center

Tel Litwinsky, Ramat- Gan, Israel

Location

Study Officials

  • Ofir Frenkel, M.D

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ofir Frenkel, M.D

CONTACT

+972529243399Ofir.Frenkel@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2015

First Posted

December 29, 2015

Study Start

February 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

December 29, 2015

Record last verified: 2015-12

Locations

IL(1)