- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04284397
Identification of Critical Thermal Environments for Aged Adults
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Lacy M Alexander, Ph.D.
- Phone Number: 8148671781
- Email: lma191@psu.edu
Study Locations
-
-
Pennsylvania
-
University Park, Pennsylvania, United States, 16802
- Recruiting
- Noll Laboratory
-
Contact:
- W. Larry Kenney, Ph.D.
- Phone Number: 814-863-1672
- Email: w7k@psu.edu
-
Contact:
- S. Tony Wolf, Ph.D.
- Phone Number: 814-863-8557
- Email: saw85@psu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Critical Environmental Limits
Subjects will perform exercise at ~200-300W with ambient temperature or humidity increasing every 5 min throughout the trial until core temperature begins to rise.
|
All participants will be tested with no treatment.
|
Experimental: Aspirin Supplementation
After a minimum of 7 days of daily, low-dose aspirin ingestion, older subjects will repeat critical environmental limits trials.
As before, subjects will perform exercise at ~200-300W with ambient temperature or humidity increasing every 5 min throughout the trial until core temperature begins to rise.
|
A sub-group of older adults will be re-tested after 7 days of treatment with low-dose aspirin.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Through study completion, an average of 1 year.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Continuous throughout visit until completion of exercise; an average of 2 hours.
|
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
|
Immediately before and immediately after exercise.
|
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
|
Continuous throughout visit until completion of exercise; an average of 2 hours.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: W. Larry Kenney, Ph.D., The Pennsylvania State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- Study14062
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aging
-
Tuba MadenCompletedAging | Aging Problems | Aging Disorder
-
Radboud University Medical CenterNot yet recruitingAging | Aging Well | Immuno Aging
-
University of Santiago de CompostelaEuropean Regional Development Fund; Center for Industrial Technological Development...Completed
-
TruDiagnosticBlushield USANot yet recruitingAging | Aging Well
-
San Diego State UniversityCompleted
-
Lithuanian Sports UniversityCompletedAging | Healthy AgingLithuania
-
Amazentis SAproDERM GmbHCompleted
-
University of West AtticaNot yet recruiting
-
University of Santiago de CompostelaAgencia Estatal de Investigación, SpainRecruiting
-
Beijing HospitalBGI-ShenzhenCompletedAging | Healthy Aging
Clinical Trials on Control
-
Claudia M. WittCompleted
-
University of California, San FranciscoWithdrawn
-
The George InstituteChanghai Hospital; University of CalgaryNot yet recruiting
-
Universidad Nacional de Educación a DistanciaMinisterio de Economía y Competitividad, SpainUnknownChronic Pain | FibromyalgiaSpain
-
University of California, Los AngelesThe National Council on Aging; City of Los Angeles Department of Aging; Los Angeles...Completed
-
Queen's University, BelfastPublic Health Agency, Health and Social Care Research and Development; Tiny...Completed
-
National Taiwan University HospitalEnrolling by invitationCognitive Function | Atrial Fibrillation, PersistentTaiwan
-
Takeshi MorimotoUniversity of the RyukyusActive, not recruitingCoronary Artery Disease | Hypertension | Type 2 Diabetes | DyslipidemiaJapan
-
Johnson & Johnson Vision Care, Inc.TerminatedRefractive Error CorrectionUnited States
-
Vanderbilt University Medical CenterCompleted