NCT04353076

Brief Summary

Climate change not only affects the planet's natural resources, but also severely impacts human health. An individual's ability to adequately cope with short- or long-term increases in ambient temperature is critical for maintaining health and wellbeing. Prolonged increases in temperature (heatwaves) pose a serious health risk for older adults, who have a reduced capacity to efficiently regulate body temperature. However, information regarding the impact of age on body temperature regulation during prolonged exposure to extreme heat is lacking, as is research on the effectiveness of interventions aimed at reducing heat strain in such situations. This project will address these important knowledge gaps by exposing healthy young and older adults to a prolonged (9 hour) heat exposure, with conditions representative of heatwaves in temperate continental climates. An additional cohort of older adults will complete the same heatwave simulation but will be briefly (2 hours) exposed to cooler conditions (22-23°C) mid-way through the session (akin to visiting a cooling centre or cooled location). The investigators will evaluate age-related differences in the capacity to dissipate heat via direct air calorimetry (a unique device that permits the precise measurement of the heat dissipated by the human body) and their effect on the regulation of body temperature. The investigators anticipate that older adults will exhibit progressive increases in the heat stored in the body throughout the simulated heatwave, resulting in progressive increases in body core temperature. Further, older adults exposed to brief-mid day cooling will rapidly gain heat upon re-exposure to high ambient temperatures. As a result, by the end of exposure body temperatures will be similar to the group not removed from the heat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

2.3 years

First QC Date

April 13, 2020

Last Update Submit

August 11, 2021

Conditions

Keywords

HeatwaveHeat-vulnerabilityCooling centerHeat strainCardiovascular responses

Outcome Measures

Primary Outcomes (4)

  • Body heat storage

    Cumulative amount of heat stored within the body

    First 3 hours (hours 1-3) of simulated heatwave

  • Body heat storage

    Cumulative amount of heat stored within the body

    Final 3 hours (hours 7-9) of simulated heatwave

  • Rectal temperature

    Index of core body temperature

    Hour 3 of simulated heatwave

  • Rectal temperature

    Index of core body temperature

    Hour 9 of simulated heatwave

Secondary Outcomes (19)

  • Heart rate

    Hour 3 of simulated heatwave

  • Heart rate

    Hour 9 of simulated heatwave

  • Systolic blood pressure

    Hour 3 of simulated heatwave

  • Systolic blood pressure

    Hour 9 of simulated heatwave

  • Diastolic blood pressure

    Hour 3 of simulated heatwave

  • +14 more secondary outcomes

Study Arms (3)

Young adults

EXPERIMENTAL

Young adults exposed to a 9-hour simulated heatwave (40°C, 15% relative humidity)

Other: Simulated heatwave exposure

Older adults (no cooling)

EXPERIMENTAL

Older adults exposed to a 9-hour simulated heatwave (40°C, 15% relative humidity)

Other: Simulated heatwave exposure

Older adults (cooling)

EXPERIMENTAL

Older adults exposed to a 9-hour simulated heatwave (40°C, 15% relative humidity) with ambient cooling intervention (i.e., exposure to an air-conditioned room) for hours 5-6.

Other: Simulated heatwave exposure with mid-day cooling

Interventions

Young and older adults (no cooling) are exposed to a 9-hour simulated exposure.

Older adults (no cooling)Young adults

Older adults (cooling) are exposed to a 9-hour simulated exposure with mid-day ambient cooling.

Older adults (cooling)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female (non-pregnant) adults with or without a) chronic hypertension (elevated resting blood pressure; as defined by Heart and Stroke Canada and Hypertension Canada), b) type 2 diabetes as defined by Diabetes Canada, with at least 5 years having elapsed since time of diagnosis and or c) obesity as defined by the World Health Organization (Body Mass Index \[BMI\] greater than or equal to 30).
  • non-smoking.

You may not qualify if:

  • Episode(s) of severe hypoglycemia (requiring the assistance of another person) within the previous year, or inability to sense hypoglycemia (hypoglycemia unawareness).
  • Serious complications related to your diabetes (gastroparesis, renal disease, uncontrolled hypertension, severe autonomic neuropathy).
  • Uncontrolled hypertension - BP \>150 mmHg systolic or \>95 mmHg diastolic in a sitting position.
  • Restrictions in physical activity due to disease (e.g. intermittent claudication, renal impairment, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis, etc.).
  • Use of or changes in medication judged by the patient or investigators to make participation in this study inadvisable.
  • Cardiac abnormalities identified in your physical health screening form (adults \<65 years of age and older; adults \<60 years of age and older with diabetes and or hypertension) or during exercise stress testing as assessed by 12-lead (all adults ≥65 years of age and older).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N6N5, Canada

Location

Related Publications (3)

  • Journeay WS, McCormick JJ, King KE, Garrett JM, O'Connor FK, Hutchins KP, Meade RD, Kenny GP. Serum endothelial monocyte-activating polypeptide-II response after 9 h of passive heat exposure: influence of age, diabetes, or hypertension. Am J Physiol Regul Integr Comp Physiol. 2026 Feb 1;330(2):R119-R125. doi: 10.1152/ajpregu.00307.2025. Epub 2026 Jan 9.

  • Garrett JM, McCormick JJ, King KE, Meade RD, Boulay P, Sigal RJ, O'Connor FK, Kenny GP. Irisin and betatrophin responses to 9 h of passive heat exposure: Influence of age, hypertension, and type 2 diabetes. Physiol Rep. 2025 Jun;13(12):e70411. doi: 10.14814/phy2.70411.

  • Lee B, Meade R, Davey S, Thake C, McCormick J, King K, Kenny GP. Effect of brief ambient cooling on serum stress biomarkers in older adults during a daylong heat exposure: a laboratory-based heat wave simulation. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-8. doi: 10.1139/apnm-2024-0476.

MeSH Terms

Conditions

Heat Stress Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Glen P Kenny, PhD

    University of Ottawa

    PRINCIPAL INVESTIGATOR
  • Ronald J Sigal, MD, MPH

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor, University Research Chair

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 20, 2020

Study Start

January 1, 2019

Primary Completion

April 2, 2021

Study Completion

April 2, 2021

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations