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Thermal Tolerance Assessment for Aging Adults

Phase < 1

Recruiting

Led By W. Larry Kenney, Ph.D.

Research Sponsored by Penn State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Asymptomatic and no signs/symptoms of disease according to the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription

All premenopausal women will be eumenorrheic (by survey)

Must not have

Medications that affect thermoregulatory or cardiovascular responses to exercise

History of Chron's disease, diverticulitis, or similar gastrointestinal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how well older adults can withstand different temperatures and humidity levels. It will help to identify danger levels of heat and humidity for this population.

Who is the study for?

This trial is for adults aged 18 and older, with a focus on those who are healthy and show no signs of disease. Women must have regular menstrual cycles. Participants over 40 need doctor approval. Excluded are those on certain meds, with exercise restrictions, pregnant women, or with a history of serious diseases like cancer or diabetes.

What is being tested?

The study tests how well older adults can handle heat by having them exercise in various temperatures and humidity levels. The goal is to find the environmental limits where aging bodies struggle to regulate temperature, increasing the risk of heat-related illnesses.

What are the potential side effects?

Since this trial involves low-intensity physical activity rather than medication (except for low dose ASA), side effects may include typical exercise-related responses such as fatigue or muscle soreness but should not involve significant medical risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I feel fine and show no signs of my condition according to exercise guidelines.

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I am a premenopausal woman with regular menstrual cycles.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on medications that affect my body's response to heat or exercise.

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I have a history of Crohn's disease, diverticulitis, or a similar gut condition.

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I have had cancer, heart disease, diabetes, or metabolic syndrome before.

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I have mobility issues that prevent me from doing light physical activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Temperature and humidity limits for maintaining stable core temperature

Secondary study objectives

Core temperature

Skin temperature

Sweat rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Critical Environmental LimitsExperimental Treatment1 Intervention

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.

Group II: Aspirin SupplementationExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low dose ASA

1998

Completed Phase 3

~1890

0 / 6Eligibility criteria met