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NCT Number: NCT04284397

Identification of Critical Thermal Environments for Aged Adults

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Low dose ASA

Drug

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

Other names: Low-dose aspirin

Control

Other

All participants will be tested with no treatment.

Primary outcomes

  1. Temperature and humidity limits for maintaining stable core temperature

    Time frame: Through 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 outcomes

  1. Core temperature

    Time frame: Continuous throughout visit until completion of exercise; an average of 2 hours.

    Core temperature will be monitored throughout each experimental visit

  2. Sweat rate

    Time frame: Immediately before and immediately after exercise.

    Sweat rate will be determined by measuring nude body mass before and after each experimental visit

  3. Skin temperature

    Time frame: Continuous throughout visit until completion of exercise; an average of 2 hours.

    Skin temperature will be monitored throughout each experimental visit

Study contacts

Contact information is provided by the study sponsor or research team.

Lacy M Alexander, Ph.D.

CONTACT

[email protected]

8148671781

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2020
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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