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Risk of Heat StressNCT04160728

Occupational Heat Stress on Workers' Productivity

A study testing Work/ rest scenario, Hydration scenario and Clothing scenario in people with Risk of Heat Stress, run by Petros Dinas at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Risk of Heat Stress
What is being tested?
Work/ rest scenario, Hydration scenario and Clothing scenario
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
248 participants
Where
1 siteGreece
Study dates
5 Jul 2019to 5 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • FAME Lab, Department of Exercise Science, University of Thessaly

    Trikala, Thessaly, 42100

Other trials in Greece

About this study

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.

Read the detailed description

The participants followed the study protocol which included, one work shift of sham measurements, one work shift business as usual and four (4) different scenarios (interventions) on different work shifts. Apart from the sham measurements the rest of the scenarios were tested in a random order for different participants.

  1. Work/ rest scenario: The participants were asked to take planned breaks in the shade during their work shift. The amount of breaks taken ranged between 3 and 10 minutes every hour depending on the current work duties of the employees.
  2. Hydration scenario: The participants were advised (not forced) to drink minimum of 750 ml of water or ice - slushies, every hour during their work shift.
  3. Clothing scenario: The participants were randomly provided with different types of clothing, i.e. white breathable coveralls, ventilated garments and breathable uniform with water submerging parts, to wear during their work shift.
  4. Assisted labor: The participants in agriculture, that were carrying heavy weights were provided with "e-carts" (automated carrying vehicles), during their work shift.

Baseline data [self-reported age; body stature (Seca 213; seca GmbH \& Co. KG; Hamburg, Germany) and body mass (BC1000, Tanita corporation, Tokyo, Japan)] were collected one day prior to the measurements. Medical history of all the participants was recorded. During the field study, continuous heart rate, core temperature and mean skin temperature data were collected using wireless heart rate monitors (Polar Team2. Polar Electro Oy, Kempele, Finland), telemetric capsules (BodyCap, Caen, France), and wireless thermistors (iButtons type DS1921H, Maxim/Dallas Semiconductor Corp., USA), respectively. Skin temperature data were collected from four sites (chest, arm, thigh, and leg) and were expressed as mean skin temperature according to the formula of Ramanathan (Tsk = [0.3(chest + arm) + 0.2(thigh + leg)]). Furthermore, continuous environmental data [air temperature (°C), globe temperature (°C), relative humidity (%), and air velocity (m/s)] were collected using a portable weather station (Kestrel 5400FW, Nielsen-Kellerman, Pennsylvania, USA). Urine samples were collected at the start and the end of the work shift to evaluate the hydration status of each worker. Urine specific gravity was assessed for each urine sample using a refractometer (PAL-10S, ATAGO CO., LTD., Fukaya, Saitama Prefecture, Japan) and was classified as either hydrated (< 1.020) or dehydrated (≥ 1.020). In addition, urine colour was assessed using a urine color scale. Questionnaires were used to assess workers' perception on exertion (Borg scale), thermal comfort/sensation, humidity comfort/sensation, radiation comfort/sensation, wind speed comfort/sensation, skin wetness, sleepiness, physical demands of the workload. The Heat Strain Score Index (HSSI) was used to assess the perceived heat strain of the workers.

Video cameras installed in close proximity (about 40m) to the workers were used to assessed workers labour effort. Video recordings were analyzed on a second by second basis using time-motion analysis method. Importantly, when video cameras were not feasible to be installed real-time task analysis was used to examine workers capacity for manual labour. For that reason, an android-based application (FAME_TASK App) was used to record the tasks of the workers on a second by second basis. The App was continuously monitoring the work time spent on irregular work breaks (unplanned breaks), the duration of uninterrupted work and the time spent as lunch time or other breaks provided by management (planned breaks). The unplanned break was divided into two categories: the breaks during which the workers decided to rest in the shade (unplanned break under the shade) and the breaks during which the workers chose to stay under the sun (unplanned break under the sun). Also, the uninterrupted work was divided into nine categories: work in an outdoor environment with a low metabolic rate; work in an outdoor environment with a moderate metabolic rate; work in an outdoor environment with a high metabolic rate; work in a mixed (outdoor and indoor) environment with a low metabolic rate; work in a mixed (outdoor and indoor) environment with a moderate metabolic rate; work in a mixed (outdoor and indoor) environment with a high metabolic rate; work in an indoor environment with a low metabolic rate; work in an indoor environment with a moderate metabolic rate; work in an indoor environment with a high metabolic rate. The labor effort (i.e., low / moderate / high metabolic rate) was defined according to the ISO 8996:1994 as low, moderate and high metabolic rate. Based on these definitions, the recorded tasks were fourteen. During the work-shift, a researcher was following each worker, monitoring them with the FAME_TASK App, until they end of their work shift.

Being tested
Work/ rest scenario, Hydration scenario, Clothing scenario, "E-carts" scenario, Business as usual scenario
Keywords
heat stress, heat strain, productivity, labor, occupation, work, thermal
Medical subject headings
Heat Stress Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Work/ rest scenarioOther

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

  • Hydration scenarioOther

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

  • Clothing scenarioOther

    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

  • "E-carts" scenarioOther

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

  • Business as usual scenarioOther

    No interference with the usual work day of the participants

  • Sham evaluationOther

    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

Study groups in NCT04160728
Study groupRoleWhat they receive
Work/ rest scenarioExperimentalFor every hour of work, the participants were asked to take 3-10 minutes break in the shade.
Receives: Other: Work/ rest scenario
Hydration scenarioExperimentalParticipants were asked to consume at least 750ml of water or ice-slushies for every hour of work.
Receives: Other: Hydration scenario
Clothing scenarioExperimentalParticipants were asked to wear different types of clothing during the work shift i.e. ventilated garments, white breathable coveralls, clothing with water submerged parts.
Receives: Other: Clothing scenario
"E-carts" scenarioExperimentalParticipants that were involved in manual labor by carrying heavy weights were provided with "e-carts" (automated carrying vehicles)
Receives: Other: "E-carts" scenario
Business as usual scenarioSham comparatorNo interference with the usual work day of the participants.
Receives: Other: Business as usual scenario
Sham evaluationSham comparatorParticipants 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.
Receives: Other: Sham evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart rate

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

    Measured: 12-hour workshift

  2. Mean skin temperature

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

    Measured: 12-hour workshift

  3. 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

    Measured: 12-hour workshift

  4. 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

    Measured: Pre and post the 12-hour workshift

  5. 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

    Measured: 12-hour workshift

  6. Thermal comfort

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

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

  7. Thermal sensation

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

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

  8. Perceived exertion

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

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

  9. 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

    Measured: At the end of the 12-hour work shift

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2019
  2. Study start5 Jul 2019
  3. Primary completion5 Aug 2019
  4. Study completion5 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04160728
Sponsor's protocol ID
7. Workers' heat stress
Status last verified
Nov 2023
First submitted
7 Nov 2019
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39965897

Questions about this trial

What is this clinical trial studying?

A study testing Work/ rest scenario, Hydration scenario and Clothing scenario in people with Risk of Heat Stress, run by Petros Dinas at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart rate (time frame: 12-hour workshift). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04160728, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.

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