NCT04625634

Brief Summary

The purpose of this study is to determine differences in physiological recovery between two consecutive days of simulated fire suppression work. The secondary purpose is to determine differences in heat gain and heat loss between two consecutive days of simulated fire suppression work. Subjects will complete two consecutive days of simulated structural firefighting shift work, 24 hours apart. Before and after each laboratory visit, subjects will continuously wear a Holter monitor and ambulatory blood pressure monitor to quantify parasympathetic tone and recovery from work.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

2.4 years

First QC Date

November 6, 2020

Last Update Submit

July 22, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Core temperature

    Gastrointestinal temperature measured with an ingestable pill.

    20 minutes

  • Heart rate

    Heart rate measured with a wearable heart rate strap and monitor

    20 minutes

Study Arms (1)

Consecutive work

EXPERIMENTAL

Subjects will complete 2 consecutive days of simulated firefighting tasks in the heat. The simulated work consists of 20 minutes of simulated structural work in a hot environment, followed by 20 minutes of seated rest in a temperate room, mimicking a typical recovery period in structural firefighting. Subjects then re-enter the environmental chamber and complete 23 minutes of simulated overhaul work in a temperate environment.

Other: 2 days of work heat stress

Interventions

2 consecutive days of identical simulated structural firefighting tasks.

Consecutive work

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • y old men and women
  • Self-reported to be healthy

You may not qualify if:

  • History of any cardiovascular, neurologic, renal, or metabolic disease
  • Current tobacco use or regular use within the last 2 years
  • Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, acetaminophen, ibuprofen, beta blockers, diuretics, psychotropics, etc.)
  • History of exertional heat stroke
  • Currently pregnant or breastfeeding, or planning to become pregnant during the study
  • Inability to follow the rules of the protocols or understand the consent form
  • No contraindications for ingestion of the gastrointestinal temperature pill

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Research and Exercise in Special Environments

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

HyperthermiaHeat Stress Disorders

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Repeated measures study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 12, 2020

Study Start

December 2, 2019

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Individual data can be made available upon written request.

Locations