Effects of Solar Radiation on Human Function and Cognition

Heat Stress Clinical Trial

Official title:

Effects of Solar Radiation on Human Function and Cognition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04160741
• Other study ID #: 6. Solar radiation & Thermo
• Status: Completed
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: May 27, 2019

Study information

• Verified date: November 2023
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Volunteers were exposed to four different environmental conditions [two hot environments: 30°C WBGT (1st: air temperature = 32.6°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 800 W/m2 and 2nd. air temperature = 40.6°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 0 W/m2) and two neutral environments: 20°C WBGT (1st: air temperature = 19.1°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 800 W/m2 and 2nd. air temperature = 28.5°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 0 W/m2], over an equal number of days. The aforementioned environmental scenarios were randomly allocated for each volunteer. To minimize participant bias, the true purpose of the study was hidden from the volunteers. Of course, once the data collection was completed, all volunteers were informed about the true purpose of the study and gave their permission to analyze and publish these data. During this blinded randomized controlled trial, all volunteers participated four times in an experimental protocol with a total duration of 03:20:00, following an hour of preparation and baseline tests. The protocol had three main time periods [rest (two hours), work (cycling) at 100 W (one hour), and recovery (twenty minutes)]. Anthropometrical data [age; body stature (Seca 213; seca GmbH & Co. KG; Hamburg, Germany); body mass (BC1000, Tanita corporation, Tokyo, Japan); body fat (DXA scan: Lunar DPX Madison, GE Healthcare, Wisconsin, USA); and lean mass (DXA scan: Lunar DPX Madison, GE Healthcare, Wisconsin, USA)] were collected two days prior to the experiments. Volunteers were euhydrated prior to the experiments. Hydration status was assessed using a handheld refractometer (ATAGO Ltd, Tokyo, Japan) and determined as either euhydrated (USG < 1.020) or dehydrated (USG ≥ 1.020) according to the current guidelines. Water consumption was restricted during the experimental protocol. The same clothing consisting of a light-blue t-shirt (100% cotton), a black exercise short pant (100% polyester), and a pair of medium-high socks (100% cotton) were used by volunteers throughout the experiments. A pair of sunglasses was mandatory to be worn throughout the experiments. Furthermore, experiments took place during the same hour of the day for each participant and an 8-hour fasting was ensured prior to the experiments. Furthermore, participants were requested to avoid caffeine and alcohol consumption for at least twelve hours before the experiments, as well as to avoid salt and sugar consumption eight hours before the experiments. During the study, continuous heart rate, core temperature, mean skin temperature, skin blood flow, and sweat rate were measured. Specifically, heart rate was collected using wireless heart rate monitors (Polar Team2. Polar Electro Oy, Kempele, Finland). Core temperature was collected using telemetric capsules (BodyCap, Caen, France). Skin temperature from four sites was measured using wireless thermistors (iButtons type DS1921H, Maxim/Dallas Semiconductor Corp., USA) and was expressed as mean skin temperature according to Ramanathan [mean skin temperature = 0.3(chest + arm) + 0.2(thigh + leg). Skin blood flow was measured with a laser Doppler flowmeter (PeriFlux 4000, Perimed, Stockholm, Sweden) at right forearm (brachioradialis) and leg (gastrocnemius). The probe (PROBE 413 Integrating Probe, Perimed, Stockhold, Sweden) was held in place with a plastic holder (PH 13, Perimed, Stockhold, Sweden). Sweat rate was measured at three regions [forehead, thigh (quadricep), and arm (bicep)] using ventilated capsule method. Thermal comfort (1 = comfortable; 5 = extremely uncomfortable), thermal sensation (-3 = cold; +3 = hot), and perceived exertion (6 = no exertion at all; 20 = maximal exertion), alongside cognitive performance (vigilance, divided attention, memory test, and reaction time) were assessed at baseline, pre work condition (01:40:00), and post work (03:00:00) conditions. Volunteers entered the chamber five minutes prior to the experiments to install data loggers and accompanied sensors on their body.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 27, 2019
• Est. primary completion date: May 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non healthy individuals and smokers

Related Conditions & MeSH terms

• Heat Strain
• Heat Stress
• Heat Stress Disorders

Intervention

Other:
• Radiation and warm environment
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)
• Warm environment
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)

Radiation:
• Neutral environment with 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)

Other:
• Neutral environment without 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)

Locations

Country	Name	City	State
Greece	FAME Lab, Department of Exercise Science, University of Thessaly	Tríkala	Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
Petros Dinas

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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".
Primary	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".
Primary	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".
Primary	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".
Primary	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".
Primary	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".
Primary	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".