Short- and Long-term Health Consequences of Workers During Consecutive Days of Heat Stress

The purpose of this study is to measure fatigue and indicators of acute kidney injury during consecutive days of work in a hot environment.

Study Overview

• Status: Completed
• Conditions: Fatigue; Heat Stress
• Intervention / Treatment: Other: Hot Dry

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • Center for Research and Education in Special Environments

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hot Dry; 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.	Other: Hot Dry; 98°F (36.7°C) and 20% relative humidity environment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Riana R Pryor, PhD, University at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): March 14, 2024
• Study Completion (Actual): March 14, 2024

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 26, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Heat Stress Disorders
• Other Study ID Numbers: STUDY00005847

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No