NCT04160728

Brief Summary

Workplace heat exposure affects billions of people during their everyday work activities. Occupational heat stress impairs workers' health and capacity to perform manual labour. Therefore, the aim of this study was to observe the heat strain experienced by workers in occupational settings and test different strategies to mitigate it during actual work shifts in agriculture, manufacture, tourism, construction, and other services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

November 7, 2019

Last Update Submit

November 28, 2023

Conditions

Keywords

heat stressheat strainproductivitylaboroccupationworkthermal

Outcome Measures

Primary Outcomes (9)

  • Heart rate

    Heart rate data were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland

    12-hour workshift

  • Mean skin temperature

    Temperature at the skin surface area was continuously monitored using iButton sensors (type DS1921 H, Maxim/Dallas Semiconductor Corp., USA)

    12-hour workshift

  • Core body temperature

    Core body temperature was assessed throughout the entire work shift using telemetric capsules (e-Celsius, BodyCap, Caen, France) that was given to the workers to ingest prior to their work shift

    12-hour workshift

  • Urine specific gravity to assess the hydration status

    Urine was obtained from the participants pre and post the 12-hour work shift. Urine specific gravity (single assessment-no units) was assessed using a refractometer (PAL-10S, ATAGO CO., LTD., Fukaya, Saitama Prefecture, Japan). Urine color was assessed using a urine color scale

    Pre and post the 12-hour workshift

  • Labour effort

    Actual time (single assessment-hours) of working effort and break time during the 12-hour work shift. They were assessed by time-motion analysis (video) or real time task analysis (surveillance) on a second by second basis

    12-hour workshift

  • Thermal comfort

    Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable).

    At baseline, every two hours up until the end of the 12-hour workshift

  • Thermal sensation

    Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)

    At baseline, every two hours up until the end of the 12-hour workshift

  • Perceived exertion

    Perceived exertion was assessed via the Borg 20th Scale (6 = no exertion at all; 20 = maximal exertion)

    At baseline, every two hours up until the end of the 12-hour workshift

  • Heat Strain Score Index

    Heat Strain Score Index was assessed via the 18-question Heat Strain Score Index questionnaire that assess the heat and physiological strain

    At the end of the 12-hour work shift

Study Arms (6)

Work/ rest scenario

EXPERIMENTAL

For every hour of work, the participants were asked to take 3-10 minutes break in the shade.

Other: Work/ rest scenario

Hydration scenario

EXPERIMENTAL

Participants were asked to consume at least 750ml of water or ice-slushies for every hour of work.

Other: Hydration scenario

Clothing scenario

EXPERIMENTAL

Participants were asked to wear different types of clothing during the work shift i.e. ventilated garments, white breathable coveralls, clothing with water submerged parts.

Other: Clothing scenario

"E-carts" scenario

EXPERIMENTAL

Participants that were involved in manual labor by carrying heavy weights were provided with "e-carts" (automated carrying vehicles)

Other: "E-carts" scenario

Business as usual scenario

SHAM COMPARATOR

No interference with the usual work day of the participants.

Other: Business as usual scenario

Sham evaluation

SHAM COMPARATOR

Participants were monitored during a usual day of work shift while sham measurements were recorded in order for them to get familiarized with the study environment.

Other: Sham evaluation

Interventions

For every hour of work, the participants were asked to take 3-10 minutes break in the shade.

Work/ rest scenario

Participants were asked to consume at least 750ml of water or ice-slushies for every hour of work

Hydration scenario

Participants were asked to wear different types of clothing during the work shift i.e. ventilated garments, white breathable coveralls, clothing with water submerged parts

Clothing scenario

Participants that were involved in manual labor by carrying heavy weights were provided with "e-carts" (automated carrying vehicles)

"E-carts" scenario

No interference with the usual work day of the participants

Business as usual scenario

Participants were monitored during a usual day of work shift while sham measurements were recorded in order for them to get familiarized with the study environment

Sham evaluation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Workers in the industries of agriculture, construction, manufacture, , tourism, or other services

You may not qualify if:

  • Workers under the age of 18 or non-experienced workers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FAME Lab, Department of Exercise Science, University of Thessaly

Trikala, Thessaly, 42100, Greece

Location

Related Publications (1)

  • Ioannou LG, Tsoutsoubi L, Mantzios K, Gkikas G, Agaliotis G, Koutedakis Y, Garcia-Leon D, Havenith G, Liang J, Arkolakis C, Glaser J, Kenny GP, Mekjavic IB, Nybo L, Flouris AD. The Impact of Workplace Heat and Cold on Work Time Loss. J Occup Environ Med. 2025 Jun 1;67(6):393-399. doi: 10.1097/JOM.0000000000003332. Epub 2025 Feb 7.

MeSH Terms

Conditions

Heat Stress Disorders

Interventions

Commerce

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Study Officials

  • Andreas Flouris

    andreasflouris@gmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher in human physiology

Study Record Dates

First Submitted

November 7, 2019

First Posted

November 13, 2019

Study Start

July 5, 2019

Primary Completion

August 5, 2019

Study Completion

August 5, 2019

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations