NCT04624919

Brief Summary

The purpose of this study is to determine the impact of varying hot environments on physiological and perceptual fatigue during work.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

1.6 years

First QC Date

October 30, 2020

Last Update Submit

October 13, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Smoothness of movement

    The variable, jerk, determines smoothness or unevenness of physical movement during work. This is measured using accelerometers placed along the spine, ankle, and shoulder.

    90 minutes

  • Energy Expenditure

    The amount of energy the body is expending during work. This is measured using indirect calorimetry.

    90 minutes

Secondary Outcomes (1)

  • Perceptual fatigue

    90 minutes

Study Arms (2)

Hot/Dry

ACTIVE COMPARATOR
Other: Hot/Dry

Warm/Humid

EXPERIMENTAL
Other: Warm/Humid

Interventions

Hot/DryOTHER

Work is completed in a hot/dry environment.

Hot/Dry

Work is completed in a warm/humid environment

Warm/Humid

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
  • Current musculoskeletal injury
  • Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, acetaminophen, ibuprofen, beta blockers, diuretics, psychotropics, etc.)
  • 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
  • Contraindications of consuming a core temperature monitoring 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

Related Publications (1)

  • Bartman NE, Vargas NT, Cavuoto LA, Hostler D, Pryor RR. Heat strain differences walking in hot-dry and warm-wet environments of equivalent wet bulb globe temperature. Temperature (Austin). 2024 Aug 26;11(4):333-349. doi: 10.1080/23328940.2024.2384185. eCollection 2024.

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized, counterbalanced crossover design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 12, 2020

Study Start

December 10, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

October 14, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Individual participant data can be made available upon written request.

Locations