NCT07046026

Brief Summary

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 across two consecutive days of work. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Sep 2028

Typical duration for not_applicable

Status
not yet recruiting

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

June 22, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
3.2 years until next milestone

Study Start

First participant enrolled

September 1, 2028

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

June 22, 2025

Last Update Submit

June 22, 2025

Conditions

HyperthermiaFatigue; HeatWork-Related Condition

Keywords

hyperthermiaworker

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Standard work pace first

ACTIVE COMPARATOR

The order of the interventions is standard work pace first, followed by the rest trial second.

Behavioral: Standard work paceBehavioral: Additional rest breaks

Additional rest breaks first

EXPERIMENTAL

The order of the interventions is the additional rest breaks first and the standard work pace second.

Behavioral: Standard work paceBehavioral: Additional rest breaks

Interventions

Standard work paceBEHAVIORAL

On two consecutive days, participants will work at a standard pace of one box per minute during the box carrying protocol

Additional rest breaks firstStandard work pace first
Additional rest breaksBEHAVIORAL

On two consecutive days, participants will work at the standard work pace during the box carrying protocol and have superimposed 5 minutes of rest every 30 minutes.

Additional rest breaks firstStandard work pace first

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy individuals
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HyperthermiaHeat Stress Disorders

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Central Study Contacts

Riana Pryor

CONTACT

716-829-5456rpryor@buffalo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2025

First Posted

July 1, 2025

Study Start (Estimated)

September 1, 2028

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Last Updated

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
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.
Access Criteria
Pooled and de-identified data will be made available to interested researchers upon email request.