NCT04160741

Brief Summary

Solar radiation is a physical phenomenon which interacts with any human being throughout its life on earth. This interaction is associated with numerous physiological functions, as well as a broad spectrum of deleterious effects on human health and wellbeing. The aim of this study is to elucidate the effects of solar radiation on human function and cognition in environmental conditions characterized by the same thermal stress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2019

Completed
5 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

3 months

First QC Date

November 7, 2019

Last Update Submit

November 28, 2023

Conditions

Keywords

heat stressheat strainsolar radiationresponsescognitionthermal

Outcome Measures

Primary Outcomes (12)

  • Heart rate

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

    03 hours and 20 minutes

  • Mean skin temperature

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

    03 hours and 20 minutes

  • Core body temperature

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

    03 hours and 20 minutes

  • Skin blood flow

    Skin blood flow was measured throughout the entire protocol with a laser Doppler flowmeter (PeriFlux 4000, Perimed, Stockholm, Sweden) at right forearm (brachioradialis) and leg (gastrocnemius)

    03 hours and 20 minutes

  • Sweat rate

    Sweat rate was measured throughout the entire protocol at three regions \[forehead, thigh (quadricep), and arm (bicep)\] using ventilated capsule method

    03 hours and 20 minutes

  • Perceived exertion

    We used the Borg 20th Scale (6 = no exertion at all; 20 = maximal exertion)

    Participants were assessed at baseline and every half an hour up until the end of the protocol at "hour 3".

  • Cognitive performance (Vigilance)

    Vigilance was assessed via vigilance test. In this task two squares arranged vertically. A pattern jumps from one square to the other. Sometimes the pattern remains in one square. In this case volunteers had to touch the screen of a tablet computer as fast as possible. The total duration for the current task was set to 6 minutes. This is a well-known vigilance test described in the Test for Attentional Performance and previously used in the literature.

    Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".

  • Thermal comfort

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

    Participants were assessed at baseline and every half an hour up until the end of the protocol at "hour 3".

  • Thermal sensation

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

    Participants were assessed at baseline and every half an hour up until the end of the protocol at "hour 3".

  • Cognitive performance (Divided Attention)

    Divided attention task incorporates both auditory and visual stimuli in parallel. During the test a number of visual stimuli (crosses) appear in a random configuration in a 4X4 matrix. At the same time volunteers hear high and low beeps in a random order. The task is to detect whether crosses form a square and at the same time two high or low beeps are emitted twice in a row. This is a well-known vigilance test described in the Test for Attentional Performance and previously used in the literature.

    Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".

  • Cognitive performance (Memory Test)

    This is a computerized version of Sternberg's memory task. In this task volunteers had to observe carefully a random sequence of one to six digits (0 to 9) painted in white and displayed for 1.2 seconds each. Thereafter, a two second delay was followed by a random test digit filled in yellow color. Participants had to response as fast as possible by pressing "yes" or "no" button to indicate where the yellow digit appeared in the previous sequence or not, respectively. In this test participants were tested in 24 trials.

    Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".

  • Cognitive performance (Reaction Time)

    In this task participants had to respond as quickly as possible, by untouching the screen, after receiving a visual or acoustic stimulus.

    Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".

Study Arms (4)

Hot environment with radiation

EXPERIMENTAL

Exposure to hot environment (30°C WBGT) with radiation (800 W/m2) Exposure for 03:20:00: * rest (two hours) * work (cycling) at 100 W (one hour) * recovery (twenty minutes)

Other: Radiation and warm environment

Hot environment without radiation

EXPERIMENTAL

Exposure to hot environment (30°C WBGT) with radiation (0 W/m2) Exposure for 03:20:00: * rest (two hours) * work (cycling) at 100 W (one hour) * recovery (twenty minutes)

Other: Warm environment

Neutral environment with radiation

EXPERIMENTAL

Exposure to neutral environment (20°C WBGT) with radiation (800 W/m2) Exposure for 03:20:00: * rest (two hours) * work (cycling) at 100 W (one hour) * recovery (twenty minutes)

Radiation: Neutral environment with radiation

Neutral environment without radiation

ACTIVE COMPARATOR

Exposure to neutral environment (20°C WBGT) with radiation (0 W/m2) Exposure for 03:20:00: * rest (two hours) * work (cycling) at 100 W (one hour) * recovery (twenty minutes)

Other: Neutral environment without radiation

Interventions

Exposure to hot environment (30°C WBGT) with radiation (800 W/m2) Exposure for 03:20:00: * rest (two hours) * work (cycling) at 100 W (one hour) * recovery (twenty minutes)

Hot environment with radiation

Exposure to hot environment (30°C WBGT) with radiation (0 W/m2) Exposure for 03:20:00: * rest (two hours) * work (cycling) at 100 W (one hour) * recovery (twenty minutes)

Hot environment without radiation

Exposure to neutral environment (20°C WBGT) with radiation (800 W/m2) Exposure for 03:20:00: * rest (two hours) * work (cycling) at 100 W (one hour) * recovery (twenty minutes)

Neutral environment with radiation

Exposure to neutral environment (20°C WBGT) with radiation (0 W/m2) Exposure for 03:20:00: * rest (two hours) * work (cycling) at 100 W (one hour) * recovery (twenty minutes)

Neutral environment without radiation

Eligibility Criteria

Age18 Years - 75 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy non-smoker individuals who exercise at least three times per week

You may not qualify if:

  • Non healthy individuals and smokers

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

MeSH Terms

Conditions

Heat Stress Disorders

Interventions

Radiation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Phenomena

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
Senior Researcher in human physiology

Study Record Dates

First Submitted

November 7, 2019

First Posted

November 13, 2019

Study Start

February 15, 2019

Primary Completion

May 27, 2019

Study Completion

May 27, 2019

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations