Identification of Critical Thermal Environments for Aged Adults

Aging Clinical Trial

Official title:

Identification of Critical Thermal Environments for Aged Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04284397
• Other study ID #: Study14062
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 30, 2020
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2024
• Source: Penn State University
• Contact: Lacy M Alexander, Ph.D.
• Phone: 8148671781
• Email: lma191[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aging

Intervention

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

Other:
• Control
All participants will be tested with no treatment.

Locations

Country	Name	City	State
United States	Noll Laboratory	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature and humidity limits for maintaining stable core temperature	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.	Through study completion, an average of 1 year.
Secondary	Core temperature	Core temperature will be monitored throughout each experimental visit	Continuous throughout visit until completion of exercise; an average of 2 hours.
Secondary	Sweat rate	Sweat rate will be determined by measuring nude body mass before and after each experimental visit	Immediately before and immediately after exercise.
Secondary	Skin temperature	Skin temperature will be monitored throughout each experimental visit	Continuous throughout visit until completion of exercise; an average of 2 hours.