S&B Heat Stress Pilot Protocols

Study Overview
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Brief Summary
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The purpose of this study is to develop a heat stress program for the construction industry and evaluate its feasibility and appeal.

Official Title
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Measuring the Effectiveness of a Personal Cooling Vest for the Prevention of Heat Strain in Construction Workers

Conditions
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Thermal Discomfort

Intervention / Treatment
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* Device: Group A
* Device: Group B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: employed at S&B work more than 20 hours a week Exclusion Criteria: severe chronic disease (e.g. severe pulmonary or cardiovascular disease history of severe heat stroke use of a pacemaker any medical issue which would render the participant unable to wear a chest monitor and cooling vest.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personal monitoring device and a cooling vest , Then personal monitoring device only<br> | Device: Group A<br>* The intervention will take place after lunch for about 2-3 hours in regular working conditions. Group A will be fitted with a cooling and bio-harness. At the end of each workday, participants will return the monitors and vests will be removed and returned to the research station. The biomonitor's battery will be recharged and data downloaded. The ice vests will be placed in a freezer.<br>|
| Experimental: Personal monitoring device only, Then personal monitoring device and a cooling vest<br> | Device: Group B<br>* The intervention will take place after lunch for about 2-3 hours in regular working conditions. Group B will wear a bio-harness and no cooling vest.At the end of each workday, participants will return the monitors and vests will be removed and returned to the research station. The biomonitor's battery will be recharged and data downloaded. The ice vests will be placed in a freezer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thermal discomfort as assessed by the thermal comfort scale | The thermal comfort scale is a 7-point scale that asks participants to rate their level of thermal comfort ranging from the sensation of cold, cool, slightly cool, neutral, slightly warm, warm, hot | end of study (about 2 hours after start) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Heart rate as assessed by the Zephyr BioHarness 3.0 device |  | from baseline to end of study (2 hours after baseline) | 
| Estimated core body temperature as assessed by the Zephyr BioHarness 3.0 device |  | from baseline to end of study (2 hours after baseline) | 
| Respiratory rate as assessed by the Zephyr BioHarness 3.0 device |  | from baseline to end of study (2 hours after baseline) | 
| Caloric burn as assessed by the Zephyr BioHarness 3.0 device |  | from baseline to end of study (2 hours after baseline) | 
| Hydration status as indicated by urine specific gravity as assessed by a clinical refractometer analysis of urine sample |  | from baseline to end of study (2 hours after baseline) |