MedPath

Protective Cooling Measures to Safeguard Elderly People From Dangerous Summer Heat

Not Applicable
Not yet recruiting
Conditions
Hyperthermia
Hypertension
Heat Stress
Heat; Weather
Aging
Type2 Diabetes
Interventions
Other: Hybrid cooling
Other: No cooling (control)
Other: Recommended cooling
Registration Number
NCT05274009
Lead Sponsor
University of Ottawa
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
60
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Extreme heat event simulation + hybrid coolingHybrid coolingAdults aged 60-85 years with or without type 2 diabetes and/or hypertension
Extreme heat event simulation + no cooling (control)No cooling (control)Adults aged 60-85 years with or without type 2 diabetes and/or hypertension
Extreme heat event simulation + recommended coolingRecommended coolingAdults aged 60-85 years with or without type 2 diabetes and/or hypertension
Primary Outcome Measures
NameTimeMethod
Core temperature (AUC)8-hour heat exposure

Rectal temperature will be measured continuously throughout each exposure and the area under the curve will be calculated.

Core temperature (peak)8-hour heat exposure

Peak rectal temperature measured during the 8-hour heat exposure.

Secondary Outcome Measures
NameTimeMethod
Heart rate temperature (peak)8-hour heat exposure

Peak rectal temperature measured during the 8-hour heat exposure.

Mean skin temperatureBefore and continuously throughout each 8 hour exposure

Mean skin temperature calculated as a weighted average of skin temperatures at 8 body regions.

Body fluid lossEvery hour during the 8-hour heat exposure

Body fluid loss calculated as a change in body weight from pre-exposure values (corrected for food intake and deification).

Stand test: Systolic response to standingPrior to and following the 8-hour heat exposure

Fall in systolic blood pressure after standing from a supine position.

Heart rate (AUC)8-hour heat exposure

Heart rate will be measured continuously throughout each exposure and the area under the curve will be calculated.

Arterial blood pressuresEvery hour during the 8-hour heat exposure

Systolic and diastolic pressures measured in triplicate.

SDNNEvery hour during the 8-hour heat exposure

Standard deviation of normal-to-normal R-R intervals measured via 3-lead ECG.

RMSSDEvery hour during the 8-hour heat exposure

Root mean squared standard deviation of normal-to-normal R-R intervals measured via 3-lead ECG.

Rate pressure productEvery hour during the 8-hour heat exposure

Rate pressure product calculated as systolic blood pressure x heart rate.

Stand test: 30:15 ratioPrior to and following the 8-hour heat exposure

30:15 ratio calculated as the ratio of the RR interval measured after 30 heart beats following standing from a supine position to that measured after 15 heart beats.

Baroreflex sensitivityPrior to and following the 8-hour heat exposure

Baroreflex sensitivity determined during cyclic stand-squat manoeuvres.

Change in plasma volumePrior to and following the 8-hour heat exposure

Change in plasma volume calculated from venous blood samples (Dill and Costill technique)

Trial Locations

Locations (1)

University of Ottawa

🇨🇦

Ottawa, Ontario, Canada

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