Renal Considerations in the Heat Stress Recommendations

NCT ID: NCT04767347

Last Updated: 2023-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-05-04

Brief Summary

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An epidemic of chronic kidney disease is occurring in laborers who undertake physical work outdoors in hot conditions. The reason for this is unknown, but may be related to kidney dysfunction caused by increases in body temperature and dehydration. The current heat stress recommendations for workers were not developed with regards for kidney health. The purpose of this study is to determine if the current recommendations protect against kidney dysfunction.

Detailed Description

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Conditions

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Hot Weather; Adverse Effect Kidney Dysfunction Kidney Injury Hyperthermia Dehydration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study will systematically examine the NIOSH recommendations for prescribing work-to-rest ratios during occupational heat stress on kidney function.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The participant will not be directly informed of the experimental conditions and will be blinded to the hypotheses.

The outcomes assessor will be blinded to the experimental conditions when analyzing the data.

Study Groups

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Fixed Work Rate

Participants will walk on a treadmill at 3 mph and the grade will be adjusted to elicit 430 W of metabolic heat production (the most common work intensity). This study will systematically examine the NIOSH recommendations for prescribing work-to-rest ratios with increasing environmental heat stress (defined as Wet Bulb Globe Temperature, WBGT) at this fixed rate of metabolic heat production on kidney function.

Group Type EXPERIMENTAL

23.0°C WBGT - Fixed Work Rate

Intervention Type OTHER

For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions:

23.0°C WBGT (29°C, 46% relative humidity) @ 60 min exercise per hour

25.5°C WBGT - Fixed Work Rate

Intervention Type OTHER

For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions:

25.5°C WBGT (31°C, 52% relative humidity) @ 45 min exercise per hour

27.5°C WBGT - Fixed Work Rate

Intervention Type OTHER

For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions:

27.5°C WBGT (33°C, 53% relative humidity) @ 30 min exercise per hour

28.5°C WBGT - Fixed Work Rate

Intervention Type OTHER

For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions:

28.5°C WBGT (34°C, 54% relative humidity) @ 15 min exercise per hour

35.5°C WBGT - Fixed Work Rate

Intervention Type OTHER

For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions:

35.5°C WBGT (40°C, 65% relative humidity) @ 15 min exercise per hour

Fixed work-to-rest ratio

This study will systematically examine the NIOSH recommendations on changes in kidney function when the work-to-rest ratio is fixed at 30 min per hour (the most commonly prescribed work-to-rest ratio), but the rate of metabolic heat production and environmental heat stress differs (Figure 2). As described in Study 1, the appropriate rate of metabolic heat production will be elicited by having participants walk on a treadmill at 3 mph and the grade will be adjusted accordingly.

Group Type EXPERIMENTAL

26.0°C WBGT - Fixed work-to-rest ratio

Intervention Type OTHER

For four hours, participants will walk on a treadmill at differing levels of metabolic heat production and environmental conditions (noted below), but at a fixed work-rest ratio of 30 minutes per hour.

26.0°C WBGT (31°C, 55% relative humidity) @ 530 W metabolic heat production

30.5°C WBGT - Fixed work-to-rest ratio

Intervention Type OTHER

For four hours, participants will walk on a treadmill at differing levels of metabolic heat production and environmental conditions (noted below), but at a fixed work-rest ratio of 30 minutes per hour.

30.5°C WBGT (36°C, 55% relative humidity) @ 230 W metabolic heat production

30.5°C WBGT - Fixed work-to-rest ratio (high intensity)

Intervention Type OTHER

For four hours, participants will walk on a treadmill at differing levels of metabolic heat production and environmental conditions (noted below), but at a fixed work-rest ratio of 30 minutes per hour.

30.5°C WBGT (36°C, 55% relative humidity) @ 530 W metabolic heat production

Interventions

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23.0°C WBGT - Fixed Work Rate

For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions:

23.0°C WBGT (29°C, 46% relative humidity) @ 60 min exercise per hour

Intervention Type OTHER

25.5°C WBGT - Fixed Work Rate

For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions:

25.5°C WBGT (31°C, 52% relative humidity) @ 45 min exercise per hour

Intervention Type OTHER

27.5°C WBGT - Fixed Work Rate

For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions:

27.5°C WBGT (33°C, 53% relative humidity) @ 30 min exercise per hour

Intervention Type OTHER

28.5°C WBGT - Fixed Work Rate

For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions:

28.5°C WBGT (34°C, 54% relative humidity) @ 15 min exercise per hour

Intervention Type OTHER

35.5°C WBGT - Fixed Work Rate

For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions:

35.5°C WBGT (40°C, 65% relative humidity) @ 15 min exercise per hour

Intervention Type OTHER

26.0°C WBGT - Fixed work-to-rest ratio

For four hours, participants will walk on a treadmill at differing levels of metabolic heat production and environmental conditions (noted below), but at a fixed work-rest ratio of 30 minutes per hour.

26.0°C WBGT (31°C, 55% relative humidity) @ 530 W metabolic heat production

Intervention Type OTHER

30.5°C WBGT - Fixed work-to-rest ratio

For four hours, participants will walk on a treadmill at differing levels of metabolic heat production and environmental conditions (noted below), but at a fixed work-rest ratio of 30 minutes per hour.

30.5°C WBGT (36°C, 55% relative humidity) @ 230 W metabolic heat production

Intervention Type OTHER

30.5°C WBGT - Fixed work-to-rest ratio (high intensity)

For four hours, participants will walk on a treadmill at differing levels of metabolic heat production and environmental conditions (noted below), but at a fixed work-rest ratio of 30 minutes per hour.

30.5°C WBGT (36°C, 55% relative humidity) @ 530 W metabolic heat production

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and women
* 18-44 y old
* Body mass index ≤35.0 kg/m2
* Self-reported to be healthy.

Exclusion Criteria

* Not within defined age range
* Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2
* Deemed highly active according to the physical activity questionnaire (i.e., \>3500 MET\*min/wk)
* Body mass index \>35.0 kg/m2
* Current or history of any renal disease, heart disease, stroke, immune or autoimmune disease, and/or gastrointestinal disease/surgery
* Hypertension during screening (systolic blood pressure \>139 or diastolic blood pressure \>89)
* Using medications that blunt the physiological response to exercise (e.g., beta blockers)
* Prescription medication with a known side effect of impaired temperature regulation or fluid balance (e.g., diuretics)
* Positive pregnancy test at any time during the study or breast feeding
* Current tobacco or electronic cigarette use or consistent use within the last 2 years
* Inability to safely complete the peak oxygen uptake test
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Zachary J. Schlader

Associate Professor of Kinesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of Public Health

Bloomington, Indiana, United States

Site Status

Countries

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United States

References

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Hess HW, Hite MJ, Heikkinen ME, Tarr ML, Tourula E, Johnson BD, Hostler D, Schlader ZJ. Critical Assessment of the Recommended Alert Limit Curves for Occupational Heat Exposure. Am J Ind Med. 2025 Sep 7. doi: 10.1002/ajim.70022. Online ahead of print.

Reference Type DERIVED
PMID: 40914830 (View on PubMed)

Hess HW, Baker TB, Tarr ML, Zoh RS, Johnson BD, Hostler D, Schlader ZJ. Occupational Heat Stress Recommendation Compliance Attenuates AKI Risk Compared with a Work-Rest Ratio-Matched, Positive Control Scenario. Kidney360. 2023 Dec 1;4(12):1752-1756. doi: 10.34067/KID.0000000000000288. Epub 2023 Nov 1.

Reference Type DERIVED
PMID: 37907448 (View on PubMed)

Hess HW, Tarr ML, Baker TB, Hostler D, Schlader ZJ. Ad libitum drinking prevents dehydration during physical work in the heat when adhering to occupational heat stress recommendations. Temperature (Austin). 2022 Jul 20;9(3):292-302. doi: 10.1080/23328940.2022.2094160. eCollection 2022.

Reference Type DERIVED
PMID: 36211944 (View on PubMed)

Other Identifiers

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1902420140

Identifier Type: -

Identifier Source: org_study_id

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