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Thermal Tolerance Assessment for Aging Adults

Q: To what ailments is low dose ASA typically prescribed?

Low dose ASA is a viable treatment for percutaneous coronary intervention (PCI), dental operations, and chronic inflammation.

Q: What qualifications must be met to participate in this trial?

This clinical trial is accepting 190 participants aged between 18 and 85. Eligibility requirements include: a BMI under 30, VO2max must fall between the 20th to 80th percentiles as outlined in the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription, HbA1C below 5.7%, Low density lipoprotein <a href="https://www.withpower.com/clinical-trials/cholesterol">cholesterol</a> at 180 mg/dl or less.

Q: Are there any vacant slots in this clinical trial?

Affirmative, based on the information reported by clinicaltrials.gov this trial is actively seeking to enrol participants. The initial announcement for the study was issued December 30th 2020 and updated February 24th 2022.

Q: Does this research project offer inclusion to persons aged twenty-five or older?

The minimum age for enrollment into this medical trial is 18 years and the maximum age allowed is 85.

Q: What is the participant count for this experiment?

Affirmative. According to clinicaltrials.gov, this research project is currently enrolling participants. The trial was published on December 30th 2020 and has been updated most recently on February 24th 2022; 190 individuals are expected across a single site.

Q: Is this research unique in its field?

Low dose ASA has been studied since 2005 when Abbott sponsored the first clinical trial, which included 15480. After this initial research phase, Low dose ASA was granted its fourth-phase drug approval in 2005 and today there are 167 ongoing trials for it spanning over 57 countries and 1398 cities.

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)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

I am a premenopausal woman with regular menstrual cycles.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Temperature and humidity limits for maintaining stable core temperature

Secondary outcome measures

Core temperature

Skin temperature

Sweat rate

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Penn State UniversityLead Sponsor

355 Previous Clinical Trials

125,567 Total Patients Enrolled

3 Trials studying Aging

488 Patients Enrolled for Aging

W. Larry Kenney, Ph.D.Principal Investigator - The Pennsylvania State University

Penn State University

1 Previous Clinical Trials

20 Total Patients Enrolled

1 Trials studying Aging

20 Patients Enrolled for Aging

Media Library

Control (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04284397 — Phase < 1

Aging Research Study Groups: Critical Environmental Limits, Aspirin Supplementation

Aging Clinical Trial 2023: Control Highlights & Side Effects. Trial Name: NCT04284397 — Phase < 1

Control (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04284397 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what ailments is low dose ASA typically prescribed?

"Low dose ASA is a viable treatment for percutaneous coronary intervention (PCI), dental operations, and chronic inflammation."

Answered by AI

What qualifications must be met to participate in this trial?

"This clinical trial is accepting 190 participants aged between 18 and 85. Eligibility requirements include: a BMI under 30, VO2max must fall between the 20th to 80th percentiles as outlined in the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription, HbA1C below 5.7%, Low density lipoprotein cholesterol at 180 mg/dl or less."

Answered by AI

Are there any vacant slots in this clinical trial?

"Affirmative, based on the information reported by clinicaltrials.gov this trial is actively seeking to enrol participants. The initial announcement for the study was issued December 30th 2020 and updated February 24th 2022."

Answered by AI

Does this research project offer inclusion to persons aged twenty-five or older?

"The minimum age for enrollment into this medical trial is 18 years and the maximum age allowed is 85."

Answered by AI

What is the participant count for this experiment?

"Affirmative. According to clinicaltrials.gov, this research project is currently enrolling participants. The trial was published on December 30th 2020 and has been updated most recently on February 24th 2022; 190 individuals are expected across a single site."

Answered by AI

Is this research unique in its field?

"Low dose ASA has been studied since 2005 when Abbott sponsored the first clinical trial, which included 15480. After this initial research phase, Low dose ASA was granted its fourth-phase drug approval in 2005 and today there are 167 ongoing trials for it spanning over 57 countries and 1398 cities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Identification of Critical Thermal Environments for Aged Adults

W. Larry Kenney 2020. "Identification of Critical Thermal Environments for Aged Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04284397.

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