Work Design Interventions for Heat Resilience

The goal of this project is to compare different ways to schedule a workday to see if older workers should follow a specific work protocol to reduce strain on the heart and muscles.

Participants will come to the lab a total of six times. During four of the visits participants will complete a box carrying task, simulating unloading a delivery truck. This will take place in a hot and humid room to simulate being outdoors during the summer.

Study Overview

• Status: Not yet recruiting
• Conditions: Hyperthermia; Work-Related Condition; Fatigue; Heat
• Intervention / Treatment: Behavioral: Standard work pace; Behavioral: Reduced-pace work; Behavioral: Increased-pace work; Behavioral: Additional rest breaks

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Riana Pryor; Phone Number: 716-829-5456; Email: rpryor@buffalo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy individuals
• 18-29 years old and 40-65 years old
• Completes at least 120 minutes of moderate to vigorous physical activity each week for at least the past 4 weeks
• Resistance trained or have recently held a job involving box carrying or a similar task

Exclusion Criteria:

• History of cardiovascular, metabolic, respiratory, neural, or renal disease
• Hypertensive (systolic blood pressure > 139 mmHg or diastolic blood pressure > 89 mmHg) or tachycardic (resting heart rate > 100 bpm) during the screening visit
• Current nicotine use or previous use within the past 6 months
• Current of previous musculoskeletal injury limiting physical activity
• A positive pregnancy test at any point during the study
• 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: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reduced-pace work first; The order of the interventions is reduced-pace work first, followed by the other interventions in a permuted block randomization design.	Behavioral: Standard work pace; Participants will work at a standard pace of one box per minute during the box carrying protocol; Behavioral: Reduced-pace work; Participants will work at a slower pace than the standard work pace of the box carrying protocol; Behavioral: Increased-pace work; Participants will work at a faster pace than the standard work pace of the box carrying protocol; Behavioral: Additional rest breaks; Participants will work at the standard work pace during the box carrying protocol and have superimposed 5 minutes of rest every 30 minutes.
Experimental: Increase-paced work first; The order of the interventions is increased-pace work first, followed by the other interventions in a permuted block randomization design.	Behavioral: Standard work pace; Participants will work at a standard pace of one box per minute during the box carrying protocol; Behavioral: Reduced-pace work; Participants will work at a slower pace than the standard work pace of the box carrying protocol; Behavioral: Increased-pace work; Participants will work at a faster pace than the standard work pace of the box carrying protocol; Behavioral: Additional rest breaks; Participants will work at the standard work pace during the box carrying protocol and have superimposed 5 minutes of rest every 30 minutes.
Experimental: Additional rest breaks first; The order of the interventions is additional rest breaks first, followed by the other interventions in a permuted block randomization design.	Behavioral: Standard work pace; Participants will work at a standard pace of one box per minute during the box carrying protocol; Behavioral: Reduced-pace work; Participants will work at a slower pace than the standard work pace of the box carrying protocol; Behavioral: Increased-pace work; Participants will work at a faster pace than the standard work pace of the box carrying protocol; Behavioral: Additional rest breaks; Participants will work at the standard work pace during the box carrying protocol and have superimposed 5 minutes of rest every 30 minutes.
Active Comparator: Standard work pace first; The order of the interventions is standard work pace first, followed by the other interventions in a permuted block randomization design.	Behavioral: Standard work pace; Participants will work at a standard pace of one box per minute during the box carrying protocol; Behavioral: Reduced-pace work; Participants will work at a slower pace than the standard work pace of the box carrying protocol; Behavioral: Increased-pace work; Participants will work at a faster pace than the standard work pace of the box carrying protocol; Behavioral: Additional rest breaks; Participants will work at the standard work pace during the box carrying protocol and have superimposed 5 minutes of rest every 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Troponin	Serum cardiac troponin concentration	2 hours following work protocol, approximately 6 hours into the trial
Maximum Core Temperature	Highest core temperature attained during the work protocol	End of work protocol, approximately 4 hours into the trial

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 22, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: fatigue; hyperthermia; worker
• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia; Fatigue; Fever
• Other Study ID Numbers: STUDY00112233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A spreadsheet of the cleaned, de-identified individual data for all variables will be shared on at clinicaltrials.gov without restriction to ensure public availability. Individual data will be identified using unique participant identifier numbers. In addition to the datasets, a study protocol, data dictionary defining and describing all variables, and data collection instruments will be shared and associated with the relevant datasets.
• IPD Sharing Time Frame: Data from this project will be made available as soon as able and no later than the time of the final publication. Original data will be preserved indefinitely after the end of the funding period.
• IPD Sharing Access Criteria: Pooled and de-identified data will be made available to interested researchers upon email request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No