NCT07189507

Brief Summary

While an upper limit of 26°C has been shown to be protective for heat-vulnerable older occupants (DOI: 10.1289/EHP11651), this recommendation did not consider the added heat burden associated with increases in internal heat production accompanying activities of daily living or the restriction to heat loss caused by clothing insulation. To safeguard the health of older adults, health agencies worldwide recommend the remain in cool space indoors, avoid strenuous activity, wear lightweight clothing, and drink cool water regularly throughout the day. However, older adults do not sense heat as well as their younger counterparts. Consequently, they may not take appropriate countermeasures to mitigate physiological strain from indoor overheating. This may include overdressing despite high indoor temperatures. In other cases, individuals may wear insulated clothing in hot weather to observe cultural or religious modesty requirements, which serve as expressions of faith and identity rather than a tool for thermoregulation. Further, individuals may be unaware of the consequences of increases in physical activity on heat gain and may therefore not adjust their normal day-to-day activity levels to prevent potentially dangerous rises in body temperature. Consequently, this may necessitate a lowering of recommended upper indoor temperature limit during hot weather. To address these important considerations, on separate occasions the investigators will assess the change in body temperature and cardiovascular strain in older adults (65-85 years) exposed for 8 hours to the recommended indoor temperature upper limit of 26°C and 45% relative humidity equivalent humidex of 29 (considered comfortable) while they A) perform seated rest dressed in light clothing (t-shirt, shorts and socks), B) perform light exercise (stepping exercise to simulate activities of daily living, 4-4.5 METS) every hour (except during lunch hour period) dressed in light clothing, C) perform light exercise (4-4.5 METS) every hour (except during lunch hour period) dressed in light clothing (t-shirt, shorts and socks) and an added clothing layer (sweatshirt and sweatpants) and D) perform seated rest dressed in light clothing (t-shirt, shorts and socks) and an added clothing layer (sweatshirt and sweatpants). With this experimental design, investigators will assess the effects of added clothing insulation and light activity, representative in activities of daily living on physiological strain and identify whether refinements in the recommended 26°C indoor temperature limit may be required.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress41%
Sep 2025Mar 2027

First Submitted

Initial submission to the registry

September 16, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

September 23, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

September 16, 2025

Last Update Submit

April 20, 2026

Conditions

Keywords

Indoor overheatingIndoor temperaturesHeat waveThermoregulationHeat strainHeat vulnerabilityHyperthermiaElderlyThermal comfortClothingActivity

Outcome Measures

Primary Outcomes (1)

  • Core temperature (Peak) during daylong exposure to indoor temperature limit.

    Peak rectal temperature (15 min average) during exposure. Rectal temperature is measured continuously throughout the 8 hour exposure to the simulated indoor temperature upper limit.

    End of 8 hour daylong exposure

Secondary Outcomes (35)

  • Profiles of Mood States (POMS) during daylong exposure to indoor temperature limit.

    At the start (hour 0) and end of 8 hour daylong exposure

  • Environmental Symptoms Questionnaire (ESQ) during daylong exposure to indoor temperature limit.

    At the start (hour 0) and end of 8 hour daylong exposure

  • Activity levels during daylong exposure to indoor overheating

    End of 8 hour daylong exposure

  • Hydration status during daylong exposure to indoor overheating

    At the start (hour 0) and end of 8 hour daylong exposure

  • Perceived exertion scale during daylong exposure to indoor temperature limit.

    At the start (hour 0) and end of 8 hour daylong exposure

  • +30 more secondary outcomes

Study Arms (4)

Exposure to indoor temperature upper limit without physical activity and added clothing.

EXPERIMENTAL

Participants, dressed in light clothing (t-shirt, shorts and socks), perform seated rest while exposed daylong (8 hours) to an indoor temperature maintained at 26°C and 45% relative humidity (humidex equivalent of 29).

Other: Simulated indoor temperature upper limit

Exposure to indoor temperature upper limit with physical activity.

EXPERIMENTAL

Participants, dressed in light clothing (t-shirt, shorts and socks), perform light exercise (i.e., stepping, representing activities of daily living, 4-4.5 METS) every hour (except during lunch hour period) while exposed daylong (8 hours) to an indoor temperature maintained at 26°C and 45% relative humidity (humidex equivalent of 29).

Other: Simulated indoor temperature upper limit

Exposure to indoor temperature upper limit with added clothing.

EXPERIMENTAL

Participants, dressed in light clothing (t-shirt, shorts and socks) and an added clothing layer (sweatshirt and sweatpants), perform seated rest while exposed daylong (8 hours) to an indoor temperature maintained at 26°C and 45% relative humidity (humidex equivalent of 29).

Other: Simulated indoor temperature upper limit

Exposure to indoor temperature upper limit with physical activity and added clothing.

EXPERIMENTAL

Participants, dressed in light clothing (t-shirt, shorts and socks) and an added clothing layer (sweat shirt and sweat pants), perform light exercise (i.e., stepping, representing activities of daily living, 4-4.5 METS) every hour (except during lunch hour period) while exposed daylong (8 hours) to an indoor temperature maintained at 26°C and 45% relative humidity (humidex equivalent of 29).

Other: Simulated indoor temperature upper limit

Interventions

Older adults exposed to an 8-hour simulated exposure.

Exposure to indoor temperature upper limit with added clothing.Exposure to indoor temperature upper limit with physical activity and added clothing.Exposure to indoor temperature upper limit with physical activity.Exposure to indoor temperature upper limit without physical activity and added clothing.

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Non-smoking.
  • English or French speaking.
  • Ability to provide informed consent.
  • 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

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 during screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

RECRUITING

MeSH Terms

Conditions

Heat Stress DisordersHyperthermiaMotor Activity

Condition Hierarchy (Ancestors)

Wounds and InjuriesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Glen Kenny, PhD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Glen P Kenny, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor, University Research Chair

Study Record Dates

First Submitted

September 16, 2025

First Posted

September 24, 2025

Study Start

September 23, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations