Clinical trial NCT05274009: Protective Cooling Measures to Safeguard Elderly People From Dangerous Summer Heat
Official title: Evaluating the Efficacy of Cooling Centres for Limiting Heat Strain in Elderly Adults During Extreme Heat Events
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperthermia
Heat; Weather
Aging
Type2 Diabetes
Hypertension
Heat Stress
Keywords: Heat wave
Cooling center
Heat strain
Cardiovascular strain
Heat and health protection
Extreme heat events
Thermal comfort
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participant will complete 3 simulated extreme heat event exposures in random order: i) no cooling center intervention (control); ii) recommended cooling center intervention (1 x 2-hours of brief air-conditioning); and iii) hybrid cooling center intervention (2 x 1-hour interspersed brief air-conditioning)
Primary purpose: BASIC_SCIENCE

Brief summary: With the increasing incidence and severity of extreme heat events accompanying climate change, there is an urgent need for sustainable cooling strategies to protect heat-vulnerable older adults, who are at increased risk of adverse health events during heat stress. Health agencies including the World Health Organization, the United States Centers for Disease Control and Prevention, and Health Canada currently recommend visiting a cooling centre or other air-conditioned location for 1-3 hours per day during extreme heat events to mitigate hyperthermia and strain on the cardiovascular system and therefore the risk adverse health events. However, our recent trial shows that while brief air-conditioning exposure is effective for reducing body temperature and cardiovascular burden in healthy older adults, the physiological impacts of cooling abate quickly following return to the heat. The purpose of this project is therefore to assess whether shorter but more frequent air-conditioning exposure provides more effective cooling than current recommendations (a single 1-3-hour cooling bout) in older adults with or without common chronic health conditions associated with increased vulnerability to extreme heat. This will be accomplished by evaluating physiological strain in older adults with and without diabetes and/or hypertension exposed for 8 hours to conditions reflective of extreme heat events in temperate, continental climates (35°C, 60% relative humidity). Participants will complete 3 separate simulated heat event exposures: i) a control trial (no cooling throughout the 8-hour heat event); ii) a recommended cooling trial (3 hours of heat exposure followed by 2 hours cooling); and iii) a hybrid cooling trial (2 hours of heat exposure followed by 1 hour cooling, another 2 hours heat exposure followed by 1 hour cooling, and a final 2-hour heat exposure).


Eligibility criteria: Inclusion Criteria:

* Adult aged 60-85 years
* Male or female
* Body mass index \< 35 kg/m2
* For participants with type 2 diabetes: at least one year lapsed since diagnosis and hemoglobin A1c 6.0-10.5%.
* For participants with hypertension: at least one year lapsed since diagnosis or average resting blood pressure \>140 systolic or \>90 diastolic

Exclusion Criteria:

* Currently smoking or quit \<5 years ago
* Moderate or serious medical conditions (other than Type 2 diabetes or high blood pressure), particularly those known to influence physiological responses to heat exposure (e.g., diagnosed heart disease, neurological disorders)
* Heat adapted due to repeated exposure to hot environments (use sauna, recent travel to hot climates, other)
* For participants with type 2 diabetes: "Brittle" diabetes: unpredictable hypo- \& hyperglycemia. Severe cardiovascular autonomic or peripheral neuropathy (guidelines.diabetes.ca/cpg)

Primary outcomes:
measure: Core temperature (peak)
timeFrame: 8-hour heat exposure
measure: Core temperature (AUC)
timeFrame: 8-hour heat exposure
Secondary outcomes:
measure: Heart rate temperature (peak)
timeFrame: 8-hour heat exposure
measure: Heart rate (AUC)
timeFrame: 8-hour heat exposure
measure: Mean skin temperature
timeFrame: Before and continuously throughout each 8 hour exposure
measure: Arterial blood pressures
timeFrame: Every hour during the 8-hour heat exposure
measure: SDNN
timeFrame: Every hour during the 8-hour heat exposure
measure: RMSSD
timeFrame: Every hour during the 8-hour heat exposure
measure: Rate pressure product
timeFrame: Every hour during the 8-hour heat exposure
measure: Body fluid loss
timeFrame: Every hour during the 8-hour heat exposure
measure: Stand test: 30:15 ratio
timeFrame: Prior to and following the 8-hour heat exposure
measure: Stand test: Systolic response to standing
timeFrame: Prior to and following the 8-hour heat exposure
measure: Baroreflex sensitivity
timeFrame: Prior to and following the 8-hour heat exposure
measure: Change in plasma volume
timeFrame: Prior to and following the 8-hour heat exposure
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Glen P Kenny, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Ronald J Sigal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa
name: Robert D Meade, PhD
role: PRINCIPAL_INVESTIGATOR
References: