An interventional study of No cooling (control) and Electric fan (low airflow) in Hyperthermia, Weather; Heat and Heat Stress, sponsored by University of Ottawa. Completed at 1 site in Canada. Open to participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by University of Ottawa · Not applicable, Interventional, and Basic science
With the increasing regularity and intensity of hot weather and heat waves, there is an urgent need to develop heat-alleviation strategies able to provide targeted protection for heat-vulnerable older adults. While air-conditioning provides the most effective protection from extreme heat, it is inaccessible for many individuals. Air-conditioning is also energy intensive, which can strain the electrical grid and, depending on the source of electricity generation, contribute to increasing green house gas emissions. For these reasons, recent guidance has advocated the use of electric fans as a simple and sustainable alternative to air-conditioning. To date, however, only one study has assessed the efficacy of fan use in older adults and demonstrated that fans accelerate increases in body temperature and heart rate in a short-duration (\~2 hours) resting exposure to 42°C with increasing ambient humidity from 30-70%. While subsequent modelling has suggested that fans can improve heat loss via sweat evaporation in healthy older adults at air temperatures up to 38°C, there is currently no empirical data to support these claims. Further, that work assumed older adults were seated in front of a pedestal fan generating an airflow of 3·5-4·5 m/s at the front of the body. This airflow cannot be attained by most marketed pedestal fans. Studies are therefore needed to evaluate the efficacy of fans for preventing hyperthermia and the associated physiological burden in older adults in air temperatures below 38°C and determine whether the cooling effect of fans, if any, is evident at lower rates of airflow.
To address these knowledge gaps, this randomized crossover trial will evaluate body core temperature, cardiovascular strain, dehydration, and thermal comfort in adults aged 65-85 years exposed for 8 hours to conditions experienced during hot weather and heat waves in North America simulated using a climate chamber (36°C, 45% relative humidity). Each participant will complete three randomized exposures that will differ only in the airflow generated at the front of the body via an electric pedestal fan: no airflow (control), low airflow (\~2 m/s), and high airflow (\~4 m/s). While participants will spend most of the 8-hour exposure seated in front of the fan, they will also complete 4 x 10 min periods of 'activities of daily living' (\~2-2.5 METS, light stepping) at \~2 hour intervals to more accurately reflect activity patterns in the home.
478 studies on the registry are indexed under Hyperthermia; 92 are open to participants now.
This study's enrollment of 19 is below the median of 60 across 365 interventional studies indexed under Hyperthermia.
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Exclusion Criteria:
Adults aged 65-85 years with or without type 2 diabetes and/or hypertension
Other: No cooling (control)
Adults aged 65-85 years with or without type 2 diabetes and/or hypertension
Other: Electric fan (low airflow)
Adults aged 65-85 years with or without type 2 diabetes and/or hypertension
Other: Electric fan (high airflow)
Participants are exposed to 36°C, 45% relative humidity for 8 hours without cooling intervention (control condition). Drinking water is available ad libitum. Participants are seated throughout exposure, except for during 10 min periods of simulated activities of daily living (light stepping at 2-2.5 METS) performed at hours 1, 3, 5, and 7.
Participants are exposed to 36°C, 45% relative humidity for 8 hours without cooling interventions (control condition). Drinking water is available ad libitum. Participants are seated throughout exposure, except for during 10 min periods of simulated activities of daily living (light stepping at 2-2.5 METS) performed at hours 1, 3, 5, and 7. While participants are seated, an electric pedestal fan positioned 1 m away will deliver a continuous airflow of 2 m/s to the front of the body.
Participants are exposed to 36°C, 45% relative humidity for 8 hours without cooling interventions (control condition). Drinking water is available ad libitum. Participants are seated throughout exposure, except for during 10 min periods of simulated activities of daily living (light stepping at 2-2.5 METS) performed at hours 1, 3, 5, and 7. While participants are seated, an electric pedestal fan positioned 1 m away will deliver a continuous airflow of 4 m/s to the front of the body.
Core temperature (peak)
Peak rectal temperature (15 min average) during exposure. Rectal temperature is measured continuously throughout each simulated heat wave.
Time frame: End of heat exposure (hour 8)
Core temperature (AUC)
Area under the curve of rectal temperature (in degree-hours).
Time frame: End of heat exposure (hour 8)
Core temperature (end-exposure)
Rectal temperature measured at hour 8 of the simulated heat wave exposure (15-min average)
Time frame: End of heat exposure (hour 8)
Heart rate (peak)
Peak heart rate (15 min average) during exposure. Heart rate is measured continuously via 3-lead ECG throughout each simulated heat wave
Time frame: End of heat exposure (hour 8)
Heart rate (AUC)
Area under the curve of rectal temperature (total beats).
Time frame: End of heat exposure (hour 8)
Heart rate (end-exposure)
Heart rate measured at hour 8 of the simulated heat wave exposure via 3-lead ECG (15-min average)
Time frame: End of heat exposure (hour 8)
Systolic blood pressure (end-exposure)
Systolic blood pressure measured in triplicate via automated oscillometry (\~60 seconds between measures)
Time frame: End of heat exposure (hour 8)
Diastolic blood pressure (end-exposure)
Diastolic blood pressure measured in triplicate via automated oscillometry (\~60 seconds between measures)
Time frame: End of heat exposure (hour 8)
Rate pressure product (end-exposure)
Rate pressure product, an index of myocardial work and strain, calculated as systolic blood pressure x heart rate.
Time frame: End of heat exposure (hour 8)
Heart rate variability: SDNN (end-exposure)
Standard deviation of normal-to-normal RR intervals (SDNN) measured during 5 minutes of paced breathing (15 breaths/min) with participants in the seated position. SDNN will be evaluated twice, during two paced breathing periods (separated by 4 min of seated rest).
Time frame: End of heat exposure (hour 8)
Heart rate variability: RMSSD (end-exposure)
Root mean squared standard deviation of normal-to-normal RR intervals (RMSSD) measured during 5 minutes of paced breathing (15 breaths/min) with participants in the seated position. RMSSD will be evaluated twice, during two paced breathing periods (separated by 4 min of seated rest).
Time frame: End of heat exposure (hour 8)
Fluid consumption
Cumulative fluid consumption calculated by weighing participant water intake at the start and end of each hour of exposure.
Time frame: End of heat exposure (hour 8)
Fluid loss
Fluid loss calculated as the change in body mass during each exposure presented as a percentage of baseline body mass (corrected for food consumption)
Time frame: End of heat exposure (hour 8)
Change in plasma volume
Change in plasma volume from baseline values calculated from duplicate measurements of hemoglobin and hematocrit at the start and end of each exposure using the technique by Dill and Costill.
Time frame: End of heat exposure (hour 8)
Thermal comfort scale (end-exposure)
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") ranging from "extremely uncomfortable" to "extremely comfortable"(midpoint: neutral).
Time frame: End of heat exposure (hour 8)
Air movement scale (end-exposure)
Perception of air movement assessed via a visual analog scale ("How do you feel about the air movement in this room?") ranging from "much too still" to "much too breezy" (midpoint: neutral).
Time frame: End of heat exposure (hour 8)
Plan to share: Yes — Deidentified participant data will be made available with approved analysis plan and signed access agreement
Supporting information: Study protocol, Sap, Analytic code
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