- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02641535
Evaluating the Physiological Strain Induced by a BC Membrane Protective Garment Under Exercise-heat Stress Compared to a Protective Coverall
Study Overview
Status
Conditions
Detailed Description
In order to physiologically evaluate a new BC membrane protective garment for the Israeli police use under exercise-heat stress conditions, 12 healthy volunteers from the border guard will participate in this study.
The subjects will undergo 4 experiment days: Recruitment day, one day of acclimatization to heat, and 2 days of performing experiment protocol, each day dressed with different protective garment (Protective garment in current use + NBC mask, new BC membrane protective garment + 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ramat- Gan
-
Tel-Hashomer, Ramat- Gan, Israel
- Sheba Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: research arm
12 healthy volunteers from the border guard of the police forces will participate in this study. The subjects will undergo 4 experiment days:
3.2 days of performing moderate exercise under hot and humid conditions protocol, each day dressed with different protective garment:
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
physiological strain (composite)
Time Frame: 3 days for each participant
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rectal temperature
Time Frame: 3 days for each participant
|
The rectal temperature will be monitored by a rectal thermistor (YSI-401) inserted 10 cm past the anal sphincter.
|
3 days for each participant
|
Skin temperature
Time Frame: 3 days for each participant
|
The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
|
3 days for each participant
|
Heart rate
Time Frame: 4 days for each participant
|
The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
|
4 days for each participant
|
Sweat rate (composite)
Time Frame: 3 days for each participant
|
Sweat rate will be calculated from the patients' body weight and fluid balance.
|
3 days for each participant
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-15-2689-OF-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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