Short- and Long-term Health Consequences of Workers During Consecutive Days of Heat Stress
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2024
CompletedJune 17, 2024
June 1, 2024
2 years
March 11, 2022
June 14, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline in fatigue
Fatigue will be measured using accelerometry, with the primary variable being jerk, the smoothness or unevenness of movement.
Hour 4
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.
Hour 4
Study Arms (1)
Hot Dry
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy individuals
- Regularly completes aerobic exercise at least 60 min per week
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Research and Education in Special Environments
Buffalo, New York, 14214, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Riana R Pryor, PhD
University at Buffalo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 11, 2022
First Posted
March 31, 2022
Study Start
April 1, 2022
Primary Completion
March 14, 2024
Study Completion
March 14, 2024
Last Updated
June 17, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share
There is not a plan to share individual participant data with other researchers. Aggregate results will be shared via publications and/or presentations.