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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05302674
• Other study ID #: STUDY00005847
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: March 14, 2024

Study information

• Verified date: March 2024
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 14, 2024
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Heat Stress
• Heat Stress Disorders

Intervention

Other:
• Hot Dry
98°F (36.7°C) and 20% relative humidity environment

Locations

Country	Name	City	State
United States	Center for Research and Exercise in Special Environments	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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