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

23. december 2015 opdateret af: Sheba Medical Center
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Israel
    • Ramat- Gan
      • Tel-Hashomer, Ramat- Gan, Israel
        • Sheba medical center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Andet: exercise 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
physiological strain (composite)
Tidsramme: 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).
4 days for each participant

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rectal temperature
Tidsramme: 4 days for each participant
The rectal temperature will be monitored by a rectal thermistor during each heat tolerance test (HTT).
4 days for each participant
Skin temperature
Tidsramme: 4 days for each participant
The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
4 days for each participant
Heart rate
Tidsramme: 5 days for each participant
The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
5 days for each participant
Sweat rate (composite)
Tidsramme: 4 days for each participant
Sweat rate will be calculated from the patients' body weight and fluid balance.
4 days for each participant

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sheba Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2015

Primær færdiggørelse (Faktiske)

1. november 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

2. juni 2015

Først indsendt, der opfyldte QC-kriterier

2. juni 2015

Først opslået (Skøn)

4. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. december 2015

Sidst verificeret

1. december 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SHEBA-15-2235-OF-CTIL

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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