Short- and Long-term Health Consequences of Workers During Consecutive Days of Heat Stress
Primary Purpose
Heat Stress, Fatigue
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hot Dry
Sponsored by
About this trial
This is an interventional prevention trial for Heat Stress
Eligibility Criteria
Inclusion Criteria:
- Healthy individuals
- Regularly completes aerobic exercise at least 60 min per week
Exclusion Criteria:
- History of cardiovascular, metabolic, respiratory, neural, or renal disease
- Hypertensive or tachycardic during the screening visit (Systolic Blood Pressure > 139 mmHg, Diastolic Blood Pressure > 89 mmHg, heart rate > 100 bpm)
- Current tobacco or nicotine use or previous regular use within the past 2 years
- Current or previous musculoskeletal injury limiting physical activity
- Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
- A positive pregnancy test at any point during the study or currently breastfeeding
- Study physician discretion based on any other medical condition or medication
In addition, subjects will be required to ingest a core temperature capsule for internal temperature monitoring. Additional contraindications particular to core temperature monitoring pill include:
- Body weight is less eighty (80) pounds.
- The presence of any known or suspected obstructive disease of the gastrointestinal tract, including but not limited to diverticulitis and inflammatory bowel disease.
- History of disorders of impairment of the gag reflex.
- Previous gastrointestinal surgery.
- Felinization of the esophagus.
- Scheduled Nuclear Magnetic Resonance (NMR)/Magnetic Resonance Imaging (MRI) scanning during the period that the CorTemp® Core Body Temperature Sensor is within the body.
- Hypomotility disorders of the gastrointestinal tract, including but not limited to ileus.
- Cardiac pacemaker or other implanted electromedical device.
Subjects with a core temperature pill exclusion can chose to participate with a rectal thermocouple instead.
Sites / Locations
- Center for Research and Exercise in Special EnvironmentsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hot Dry
Arm Description
The participant will complete four hours of work at a 45:15 work rest cycle in a 98°F (36.7°C) and 20% relative humidity environment.
Outcomes
Primary Outcome Measures
Change from baseline in fatigue
Fatigue will be measured using accelerometry, with the primary variable being jerk, the smoothness or unevenness of movement.
Biomarkers of acute kidney injury
Tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP7) are biomarkers that have the potential for early prediction of acute kidney injury.
Secondary Outcome Measures
Full Information
NCT ID
NCT05302674
First Posted
March 11, 2022
Last Updated
February 13, 2023
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT05302674
Brief Title
Short- and Long-term Health Consequences of Workers During Consecutive Days of Heat Stress
Official Title
Short- and Long-term Health Consequences of Workers During Consecutive Days of Heat Stress
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to measure fatigue and indicators of acute kidney injury during consecutive days of work in a hot environment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heat Stress, Fatigue
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hot Dry
Arm Type
Experimental
Arm Description
The participant will complete four hours of work at a 45:15 work rest cycle in a 98°F (36.7°C) and 20% relative humidity environment.
Intervention Type
Other
Intervention Name(s)
Hot Dry
Intervention Description
98°F (36.7°C) and 20% relative humidity environment
Primary Outcome Measure Information:
Title
Change from baseline in fatigue
Description
Fatigue will be measured using accelerometry, with the primary variable being jerk, the smoothness or unevenness of movement.
Time Frame
Hour 4
Title
Biomarkers of acute kidney injury
Description
Tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP7) are biomarkers that have the potential for early prediction of acute kidney injury.
Time Frame
Hour 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy individuals
Regularly completes aerobic exercise at least 60 min per week
Exclusion Criteria:
History of cardiovascular, metabolic, respiratory, neural, or renal disease
Hypertensive or tachycardic during the screening visit (Systolic Blood Pressure > 139 mmHg, Diastolic Blood Pressure > 89 mmHg, heart rate > 100 bpm)
Current tobacco or nicotine use or previous regular use within the past 2 years
Current or previous musculoskeletal injury limiting physical activity
Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
A positive pregnancy test at any point during the study or currently breastfeeding
Study physician discretion based on any other medical condition or medication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Riana R Pryor, PhD
Phone
(716) 829-5456
Email
rpryor@buffalo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riana R Pryor, PhD
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Research and Exercise in Special Environments
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riana R Pryor, PhD, ATC
Phone
716-829-5456
Email
RPryor@buffalo.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to share individual participant data with other researchers. Aggregate results will be shared via publications and/or presentations.
Learn more about this trial
Short- and Long-term Health Consequences of Workers During Consecutive Days of Heat Stress
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