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Identification of Critical Thermal Environments for Aged Adults

Identification of Critical Thermal Environments for Aged Adults

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04284397
Enrollment
190
Registered
2020-02-25
Start date
2020-12-30
Completion date
2027-02-27
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

Aging, Thermoregulation, Heat stress

Brief summary

This study evaluates critical environmental limits (temperature and humidity) above which older adults are unable to effectively thermoregulate. Participants will exercise in a series of different environmental conditions to identify combinations of temperature and humidity above which age-related physiological changes cause uncompensable heat stress, resulting in increased risk of heat illness.

Detailed description

The earth's climate is warming well above historical averages, and there is an increased frequency, duration, and severity of heat waves. At the same time, the world's population is rapidly aging. Aging is associated with reductions in thermoregulatory capacity due to reductions in sweating and skin blood flow. For this reason, people ≥65 years exhibit exponentially larger increases in morbidity and mortality during heat waves than younger individuals, with the large majority of excess deaths during heat waves occurring in the elderly. Compounding the physiological effects of primary aging, co-morbidities and common classes of drugs taken by older adults can further compromise their thermoregulatory function. One such class of medications is cyclooxygenase inhibitors, including aspirin (ASA) and other platelet inhibitors. Provocative data published by our lab indicate that platelet inhibitors including ASA increase the rate of heat storage during passive heat stress by \ 25%. Following current clinical guidelines, nearly 40% of US adults over the age of 50 engage in an aspirin therapy regiment for the primary or secondary prevention of cardiovascular disease. Although there is compelling evidence that aging is associated with decreased heat dissipation and elevated risk of heat illness in hot ambient conditions, the significant question remains: In what specific environments does this age disparity begin to occur? The goal of the current study is to identify and model ambient conditions that are unsafe for older adults. A second aim of the study is to determine the effects of the commonly used platelet inhibitor, acetylsalicylic acid (ASA), on age-specific critical environmental limits.

Interventions

A sub-group of older adults will be re-tested after 7 days of treatment with low-dose aspirin.

OTHERControl

All participants will be tested with no treatment.

Sponsors

Penn State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Two groups of subjects (young, older) participate in twelve experiments; experimental conditions consist of six different combinations of temperature and humidity and are performed at two different exercise intensities. The experiments are conducted in randomized order and are separated by a minimum of three days. A subgroup of older adults will be asked to complete all trials after taking daily low-dose aspirin for seven days, and aspirin will be continued until all trials are complete.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Adults aged 18 and older (those 40+ years of age must be cleared by collaborating physician) * All premenopausal women will be eumenorrheic (by survey) * Asymptomatic and no signs/symptoms of disease according to the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription

Exclusion criteria

* Medications that affect thermoregulatory or cardiovascular responses to exercise * Any contraindications to low intensity physical activity on the Physical Activity Readiness Questionnaire * Any mobility restrictions that interfere with low intensity physical activity * Pregnant or planning to become pregnant in the next 12 months * Prior diagnosis of cancer, cardiovascular disease, diabetes, or metabolic syndrome * Illegal/recreational drug use * History of Chron's disease, diverticulitis, or similar gastrointestinal disease * Abnormal resting or exercise electrocardiogram (ECG)

Design outcomes

Primary

MeasureTime frameDescription
Temperature and humidity limits for maintaining stable core temperatureThrough study completion, an average of 1 year.Core temperature will be measured throughout exercise. The point at which heat stress becomes uncompensable will be determined for each environmental and exercise condition by assessing the combination of temperature and humidity at which core temperature begins to rise.

Secondary

MeasureTime frameDescription
Core temperatureContinuous throughout visit until completion of exercise; an average of 2 hours.Core temperature will be monitored throughout each experimental visit
Sweat rateImmediately before and immediately after exercise.Sweat rate will be determined by measuring nude body mass before and after each experimental visit
Skin temperatureContinuous throughout visit until completion of exercise; an average of 2 hours.Skin temperature will be monitored throughout each experimental visit

Countries

United States

Contacts

CONTACTLacy M Alexander, Ph.D.
lma191@psu.edu8148671781
PRINCIPAL_INVESTIGATORW. Larry Kenney, Ph.D.

The Pennsylvania State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026