NCT01863927

Brief Summary

The purpose of this preliminary experiment is to measure the effect of a novel ventilation system on the physiological strain during exercise in high heat load while wearing ballistic protective vest. Ten young and healthy participants will participate in the study. They will all go through a six days heat acclimation period in a heat chamber according to a valid protocol. Afterwards they will be randomly exposed to 4 conditions during four separate consecutive days.

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

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

May 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

May 8, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

May 23, 2013

Last Update Submit

May 7, 2014

Conditions

Body Temperature Changes

Outcome Measures

Primary Outcomes (2)

  • Heat tolerance test

    The test is performed in a climatic chamber at a temperature of 40oC and 40% relative humidity. During the test, the subject walks on a treadmill at a speed of 5 km/hr at a 2% grade for 2h. Body core temperature and heart rate are continuously monitored, and sweat rate is computed from body weight prior to and after the test, corrected for fluid intake. Heat intolerance is determined when body core temperature elevates above 38.5oC, when heart rate elevates above 150 bpm, or when either does not tend to reach a plateau.

    1 year

  • Maximal oxygen consumption test

    Volunteer's oxygen consumption (VO2) will be monitored continuously with a metabolic chart (ZAN), while running for 10 min on a treadmill under comfortable environmental conditions.

    1 year

Secondary Outcomes (3)

  • Skin temperature

    1 year

  • Rectal temperature

    1 year

  • Heart rate

    1 year

Study Arms (1)

Research arm

EXPERIMENTAL

Each of the participants will be randomly exposed to 4 conditions during four separate consecutive days.

Other: Research intervention

Interventions

Research interventionOTHER

After heat acclimation the participant will be randomly exposed to 4 conditions during four separate consecutive days: 1) walking on a treadmill for two hours in hot-wet conditions (30OC, 70% RH) while wearing military uniforms and a vest (control group); 2) walking on a treadmill for two hours in hot-dry conditions (40OC, 30% RH) while wearing military uniforms and a vest (control group); 3) walking on a treadmill for two hours in hot-wet conditions (30OC, 70% RH) while wearing military uniforms and a vest with a ventilator (experimental group); 4) walking on a treadmill for two hours in hot-dry conditions (40OC, 30% RH) while wearing military uniforms and a vest with a ventilator (experimental group)

Also known as: Heat exposure, exercise in hot environment
Research arm

Eligibility Criteria

Age21 Years - 28 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 21-28
  • healthy
  • after medical checkup
  • after signing concent form

You may not qualify if:

  • heart disease
  • respiratory disease
  • baseline bp above 140/90 mmHg
  • sleep disorders
  • diabetes
  • anhydrosis
  • skin disease
  • acute illness in last 3 days prior to the examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba medical center

Tel-Hashomer, Ramat- Gan, Israel

Location

MeSH Terms

Conditions

Body Temperature Changes

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Barliz Adato, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barliz Adato, MD

CONTACT

+972542662201Barliz.Adato@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Physician at the Institute of Military Physiology, Heller Institute of Medical Research

Study Record Dates

First Submitted

May 23, 2013

First Posted

May 29, 2013

Study Start

November 1, 2014

Primary Completion

November 1, 2015

Study Completion

February 1, 2016

Last Updated

May 8, 2014

Record last verified: 2014-05

Locations

IL(1)