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Heat StressNCT07189507

Suitability of the 26 °C Indoor Temperature Upper Limit for Older Adults: Impacts of Clothing and Daily Activity

A study testing Simulated indoor temperature upper limit in people with Heat Stress and Physiological Stress, run by University of Ottawa at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Heat Stress, Physiological Stress
What is being tested?
Simulated indoor temperature upper limit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
23 Sep 2025to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Glen P Kenny, PhD contact

6135625800 ext. 4282

gkenny@uottawa.ca

Canada1 site, 1 recruiting
  • University of Ottawa

    Ottawa, Ontario, K1N 6N5

    Glen P Kenny, PhD, 6135625800 ext. 4282, gkenny@uottawa.ca

    Recruiting

Other trials in Canada

About this study

Official title: Evaluation of the 26 °C Indoor Temperature Upper Limit Considering Clothing Insulation and Daily Activity in Older Adults

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.

Being tested
Simulated indoor temperature upper limit
Keywords
Indoor overheating, Indoor temperatures, Heat wave, Thermoregulation, Heat strain, Heat vulnerability, Hyperthermia, Elderly, Thermal comfort, Clothing, Activity
Medical subject headings
Heat Stress Disorders, Hyperthermia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simulated indoor temperature upper limitOther

    Older adults exposed to an 8-hour simulated exposure.

Study groups in NCT07189507
Study groupRoleWhat they receive
Exposure to indoor temperature upper limit without physical activity and added clothing.ExperimentalParticipants, 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).
Receives: Other: Simulated indoor temperature upper limit
Exposure to indoor temperature upper limit with physical activity.ExperimentalParticipants, 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).
Receives: Other: Simulated indoor temperature upper limit
Exposure to indoor temperature upper limit with added clothing.ExperimentalParticipants, 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).
Receives: Other: Simulated indoor temperature upper limit
Exposure to indoor temperature upper limit with physical activity and added clothing.ExperimentalParticipants, 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).
Receives: Other: Simulated indoor temperature upper limit

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: End of 8 hour daylong exposure

Secondary outcomes (35)
  1. Profiles of Mood States (POMS) during daylong exposure to indoor temperature limit.

    Potential changes in mood (7 subscales of mood: tension, anger, depression, fatigue, confusion, vigor and esteem related affect). The POMS-40 is a validated, self-administered questionnaire that examines seven distinct aspects of mood state across two positive subscales (Esteem-Related Affect, and Vigor) and five negative subscales (Fatigue, Tension, Confusion, Anger, and Depression), which are described across 40 distinct adjectives. For each individual item, participants were asked to describe "how you feel right now" by responding using a 5-point Likert scale (0 = "Not at all", 1 = "A little", 2 = "Moderately", 3 = "Quite a lot", or 4 = "Extremely"). The values of items associated with a specific subscale (e.g., Fatigue) were summed to calculate its score.

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

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

    Self-reported environmental reactions and medical symptomatology associated with prolonged heat exposure. The ESQ-IV is a validated 68-item, self-administered questionnaire that has been used successfully in identifying symptomatology during exposure to a wide variety of environmental conditions, including heat exposure [24, 25].

    Participants are asked to assess and described "how you have been feeling today" by responding to each item using a 6-point Likert scale (0 = "Not at all", 1 = "Slight", 2 = "Somewhat", 3 = "Moderate", 4 = "Quite a bit", or 5 = "Extreme"). Total Symptom Score was calculated from this data by taking the sum of the intensity ratings from all 68 individual items using reverse scores for the three positive items from the list ("I Felt Good", "I Felt Alert", and "I Felt Wide Awake").

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

  3. Activity levels during daylong exposure to indoor overheating

    Activity levels assessed via a wearable monitor (Actical) containing an accelerometer worn on the wrist and hip.

    Measured: End of 8 hour daylong exposure

  4. Hydration status during daylong exposure to indoor overheating

    Hydration status measured via assessing the urine specific gravity of a urine sample.

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

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

    Perceived exertional assessed via a visual analog scale ("How hard are you working?") ranging from "no exertional at all" to "maximal exertion"

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

  6. Feel good scale during daylong exposure to indoor temperature limit.

    Feel good assessed via a visual analog scale ("How good do you feel?") ranging from "very good" to "very bad"(midpoint: neutral)

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

  7. Orthostatic intolerance symptoms assessment during daylong exposure to indoor temperature limit.

    Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance during the lying to standing tests. All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort".

    Measured: At end of 8 hour daylong exposure.

  8. Thermal sensation 2 scale during daylong exposure to indoor temperature limit.

    Thermal sensation assessed via a visual analog scale ("How do you feel?") ranging from "hot" to "cold"(midpoint: neutral)

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

  9. Thermal sensation scale during daylong exposure to indoor temperature limit.

    Thermal sensation assessed via a visual analog scale ("How hot do you feel?") ranging from "extremely hot" to "neutral"(midpoint: hot)

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

  10. Arousal scale during daylong exposure to indoor temperature limit.

    Felt arousal scale assessed via a visual analog scale ("How worked up are you?") ranging from "high arousal" to "low arousal".

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

  11. Thirst sensation scale during daylong exposure to indoor temperature limit.

    Thirst sensation assessed via a visual analog scale ranging from "very, very thirsty" to "not thirsty at all".

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

  12. Thermal comfort scale during daylong exposure to indoor temperature limit.

    Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") ranging from "very uncomfortable" to "comfortable".

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

  13. Change in plasma volume during daylong exposure to indoor temperature limit.

    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.

    Measured: At end of 8 hour daylong exposure.

  14. Fluid loss during daylong exposure to indoor temperature limit.

    Fluid loss calculated as the change in body mass during each exposure presented as a percentage of baseline body mass (corrected for food consumption).

    Measured: At end of 8 hour daylong exposure

  15. Fluid consumption during daylong exposure to indoor temperature limit.

    Average hourly fluid consumption calculated by weighing participant water intake at the start and end of each hour of exposure (normalized to the exposure duration).

    Measured: At end of 8 hour daylong exposure

  16. BTrackS Balance Assessment during daylong exposure to indoor temperature limit (postural stability).

    To assess postural stability, participants will be asked to stand on a BTracks force plate with their feet spread out to shoulder width while looking straight ahead. The assessment will comprise of one trial lasting 120 seconds in length. Center of pressure (COP) vector data along vertical (y) and horizontal (x) axes will be summed for the total path excursion length (cm) during each trial.

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

  17. CDC 4-Stage Balance Test during daylong exposure to indoor temperature limit (postural stability).

    To assess postural stability, participants hold a tablet to their chest, then auditory cues guide participants through four consecutive stances, feet side by side, instep of one foot touching the big toe of the other foot, tandem stand with one foot in front of the other, heel touching toe, and stand on one foot. The balance assessment will be evaluated based on movement detected by an accelerometer integrated into the hardware of the tablet device (Sway Medical Inc).

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

  18. Impulse control during daylong exposure to indoor temperature limit (cognitive function).

    Participants will be provided with a tablet device with the Sway Medical testing platform for the assessment of impulse control. Participants will be asked to respond to both "go" and "no-go" visual cues. In response to the "go" cue, participants will initiate a movement of the device.

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

  19. Reaction time during daylong exposure to indoor temperature limit (cognitive function).

    Participants will be provided with a tablet device with the Sway Medical testing platform for the assessment of reaction time. Participants will be asked to initiate a movement of the device in response to a visual cue.

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

  20. Rate pressure product during daylong exposure to indoor temperature limit.

    Rate pressure product, an index of myocardial work and strain, calculated as systolic blood pressure x heart rate.

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

  21. Diastolic blood pressure during daylong exposure to indoor temperature limit.

    Diastolic blood pressure measured in triplicate via automated oscillometry (~60 seconds between measures).

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

  22. Systolic blood pressure during daylong exposure to indoor temperature limit.

    Systolic blood pressure measured in triplicate via automated oscillometry (~60 seconds between measures).

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

  23. Systolic response to standing from supine during daylong exposure to indoor temperature limit.

    Systolic blood pressure response to standing evaluated as the difference in blood pressure measured between the standing and supine. Standing systolic blood pressure will be taken as the lowest value of those measured after 60 and 120 seconds of standing. Systolic response to standing will be evaluated twice, during two lying-to-standing tests (separated by 10 min of supine rest).

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

  24. Cardiac response to standing from supine (30:15 ratio) during daylong exposure to indoor temperature limit.

    Cardiac response to standing evaluated as the ratio between the highest R-wave to R-wave interval (lowest heart rate) measured at the 30th heart beat after standing from supine (+/- 5 beats) and the lowest R-wave to R-wave interval (highest heart rate) measured at the 15th heart beat after standing (+/- 5 beats). Cardiac response to standing will be evaluated twice, during two lying-to-standing tests (separated by 10 min of supine rest).

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

  25. Heart rate variability: SDNN during daylong exposure to indoor temperature limit.

    Standard deviation of normal-to-normal R-wave to R-wave intervals (SDNN) measured during 5 minutes of paced breathing (15 breaths/min) with participants in the supine position. SDNN will be evaluated twice, during two paced breathing periods (separated by 4 min of supine rest).

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

  26. Heart rate variability: RMSSD during daylong exposure to indoor temperature limit.

    Root mean squared standard deviation of normal-to-normal R-wave to R-wave intervals (RMSSD) measured during 5 minutes of paced breathing (15 breaths/min) with participants in the supine position. RMSSD will be evaluated twice, during two paced breathing periods (separated by 4 min of supine rest).

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

  27. Heart rate end of daylong exposure to indoor temperature limit.

    Heart rate measured at hour 8 of exposure to indoor temperature limit (15-min average).

    Measured: End of 8 hour daylong exposure

  28. Heart rate (AUC) during daylong exposure to indoor temperature limit.

    Areas under the curve (AUC) of heart rate during the 8 hour exposure to the simulate indoor temperature upper limit.

    Measured: End of 8 hour daylong exposure

  29. Heat rate (Peak) during daylong exposure to indoor temperature limit.

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

    Measured: End of 8 hour daylong exposure

  30. Mean skin temperature end of daylong exposure to indoor temperature limit.

    Mean skin temperature measured over 7 body regions at hour 8 of exposure to indoor temperature limit (15-min average).

    Measured: End of 8 hour daylong exposure

  31. Mean skin temperature (AUC) during daylong exposure to indoor temperature limit.

    Areas under the curve (AUC) of mean skin temperature as calculated over 7 body regions during the 8 hour exposure to the simulate indoor temperature upper limit.

    Measured: End of 8 hour daylong exposure

  32. Mean skin temperature (Peak) during daylong exposure to indoor temperature limit.

    Peak mean skin temperature (15 min average) during exposure. Mean skin temperature as calculated from skin temperature measured across 7 body regions is measured continuously throughout the 8 hour exposure to the simulated indoor temperature upper limit.

    Measured: End of 8 hour daylong exposure

  33. Core temperature end of daylong exposure to indoor temperature limit.

    Rectal temperature measured at hour 8 of exposure to indoor temperature limit (15-min average).

    Measured: End of 8 hour daylong exposure

  34. Core temperature (AUC) during daylong exposure to indoor temperature limit.

    Areas under the curve (AUC) of rectal temperature during the 8 hour exposure to the simulate indoor temperature upper limit.

    Measured: End of 8 hour daylong exposure

  35. Sleep quality and quantify assessment during daylong exposure to indoor temperature limit.

    The Pittsburg Sleep Quality Index will be administered to provide an overview of the sleep quantity and quality of individuals over the previous month.

    Measured: At start of 8 hour daylong exposure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2025
  2. Study start23 Sep 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07189507
Sponsor's protocol ID
HEPRU-2025-09-A
Status last verified
Apr 2026
First submitted
16 Sep 2025
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Simulated indoor temperature upper limit in people with Heat Stress and Physiological Stress, run by University of Ottawa at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Glen P Kenny, PhD (6135625800 ext. 4282, gkenny@uottawa.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Core temperature (Peak) during daylong exposure to indoor temperature limit. (time frame: End of 8 hour daylong exposure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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