Identifying temperature limits for older adults' safety
Identification of Critical Thermal Environments for Aged Adults
EARLY_PHASE1 · Penn State University · NCT04284397
This study tests how hot and humid it can get before older adults start to feel unwell, to help keep them safe during heat waves.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Penn State University (other) |
| Locations | 1 site (University Park, Pennsylvania) |
| Trial ID | NCT04284397 on ClinicalTrials.gov |
What this trial studies
This study evaluates the critical temperature and humidity levels that older adults can tolerate without experiencing heat stress. Participants will engage in exercise under various environmental conditions to determine the thresholds at which age-related physiological changes lead to heat illness. The research aims to address the increased risk of heat-related morbidity and mortality among the elderly, particularly in the context of rising global temperatures and the common use of medications that may impair thermoregulation. By identifying these critical limits, the study seeks to enhance safety guidelines for older adults during heat waves.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older, particularly those over 40 who are cleared by a physician.
Not a fit: Patients with significant mobility restrictions, serious health conditions, or those taking medications that affect thermoregulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety guidelines for older adults during extreme heat conditions, potentially reducing heat-related illnesses and fatalities.
How similar studies have performed: While there is existing evidence on the risks of heat stress in older adults, this specific approach to identifying critical thermal environments is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
University Park, Pennsylvania
- Noll Laboratory — University Park, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: W. Larry Kenney, Ph.D. — The Pennsylvania State University
- Study coordinator: Lacy M Alexander, Ph.D.
- Email: lma191@psu.edu
- Phone: 8148671781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aging, Thermoregulation, Heat stress