- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02442947
Examination of Textile Solutions for Reducing Physiological Stress
December 23, 2015 updated by: Sheba Medical Center
Physiological Examination of Textile Solutions for Stress Reduction When Dressed in Protective Garment and Work Clothes and Under Physical and Heat Stress Conditions
Using protective or combat garments under heavy heat stress conditions, during rest or exertion, may hinder the body's ability to effectively exchange heat with the environment and thereby can lead to heat injuries.
The purpose of this research is to physiologically examine the new textile solutions that are planned to be integrated in the protective garments, combat garments and work uniforms in the army, by evaluating the physiological stress obtained during exertion under hot climatic conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
10 young, healthy civilian volunteers will participate in this study.
After reading and signing an informed consent form, all subjects will undergo medical examination which includes ECG, anthropometric measurements and Vo2max test.
Afterwards, the subjects will perform 6 acclimatization days carried out by the standard protocol of Heat Tolerance Test (HTT).
After acclimatization, the subjects will undergo 4 experiment days under heavy heat stress in a climatic chamber, dressed in each experiment day with one out of 4 clothing combinations (NBC protective garment [charcoal base], combat garment and 2 different types of work uniforms).
Physiological stress will be evaluated from rectal temperature and heart rate measurements.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ramat- Gan
-
Tel-Hashomer, Ramat- Gan, Israel
- Sheba Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Aged 18-30 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 skeledon condition.
- Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.
- Infectious disease 3 days prior to the experiment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Research arm
|
The experiment aimed at evaluating the physiological stress obtained when dressed in different clothing (NBC protective garment [charcoal base], combat garment and 2 different types of work uniforms- (1)50% cotton and 50% polyester (2)80% cotton and 20% polyester) and during exertion under heat conditions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
physiological strain (composite)
Time Frame: 10 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).
|
10 days for each participant
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rectal temperature
Time Frame: 10 days for each participant
|
The rectal temperature will be monitored by a rectal thermistor during each heat tolerance test (HTT).
|
10 days for each participant
|
Skin temperature
Time Frame: 10 days for each participant
|
The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
|
10 days for each participant
|
Heart rate
Time Frame: 10 days for each participant
|
The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
|
10 days for each participant
|
Sweat rate (composite)
Time Frame: 10 days for each participant
|
Sweat rate will be calculated from the patients' body weight and fluid balance.
|
10 days for each participant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
April 29, 2015
First Submitted That Met QC Criteria
May 10, 2015
First Posted (Estimate)
May 13, 2015
Study Record Updates
Last Update Posted (Estimate)
December 24, 2015
Last Update Submitted That Met QC Criteria
December 23, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- SHEBA-14-1853-YH-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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