Cooling Strategies for Older Adults in the Heat

NCT ID: NCT06349616

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-07-21

Brief Summary

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The earth's climate is warming, and the number of heat waves has increased in recent years. At the same time, the number of adults over the age of 65 is growing. Humans sweat and increase blood flow to the skin to cool their body when they get hot. Older adults do not do this as well as young adults. This makes it harder to safely be in warm and/or humid conditions. It is important to learn about cooling strategies for older adults to safely be in warm and/or humid conditions.

There is compelling evidence that intermittent hand and forearm cold-water immersion effectively reduces the rise of core temperature during heat stress in older adults. However, it is still unknown if this is an effective cooling strategy for older adults. Furthermore, our laboratory has shown that folic acid supplementation improves blood flow responses in older adults. This may be beneficial to older adults during heat stress.

Detailed Description

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Subjects sign an informed consent form and undergo a medical screening prior to participation. The screening includes a physical exam, anthropometry, chemical and lipid profiles.

Subjects participate in 4 experimental trials, 2 while on folic acid supplementation and 2 while on placebo. The order of treatment (folic acid supplementation or placebo) is randomized. Participants will place their hands and forearms in cold tap water intermittently for one of the two trials for each treatment. The order of the hand and forearm immersion trial is randomized for each treatment. The trials are separated by at least five days. For each experiment, core temperature, heart rate, blood pressure, skin temperature, and sweat rate are measured. Each experimental visit will last 2 hours.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Subjects participate in 4 experiments, 2 for each treatment (folic acid supplementation and placebo). The order of treatment is random.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Folic acid supplementation

5 mg/day folic acid for 6-7 weeks

Group Type EXPERIMENTAL

Intermittent cold-water hand and forearm immersion

Intervention Type OTHER

Participants will be seated at rest in a hot and humid environment. At 2 time points in the experiment, participants will place their hands and forearms in a bucket of cold tap water for 10 minutes.

No intermittent cold-water hand and forearm immersion

Intervention Type OTHER

Participants will be seated at rest in a hot and humid environment.

Control

Cellulose placebo tablet for 6-7 weeks

Group Type PLACEBO_COMPARATOR

Intermittent cold-water hand and forearm immersion

Intervention Type OTHER

Participants will be seated at rest in a hot and humid environment. At 2 time points in the experiment, participants will place their hands and forearms in a bucket of cold tap water for 10 minutes.

No intermittent cold-water hand and forearm immersion

Intervention Type OTHER

Participants will be seated at rest in a hot and humid environment.

Interventions

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Intermittent cold-water hand and forearm immersion

Participants will be seated at rest in a hot and humid environment. At 2 time points in the experiment, participants will place their hands and forearms in a bucket of cold tap water for 10 minutes.

Intervention Type OTHER

No intermittent cold-water hand and forearm immersion

Participants will be seated at rest in a hot and humid environment.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults aged 65 and older
* English proficiency

Exclusion Criteria

* Chron's disease, diverticulitis, or similar gastrointestinal disease
* Abnormal resting exercise electrocardiogram (ECG)
* Tobacco use
* High-risk determined by the Atherosclerotic Cardiovascular Disease (CVD) Risk Factor Assessment
* Antiepileptic or antiseizure medications
* Methotrexate
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Penn State University

OTHER

Sponsor Role lead

Responsible Party

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W. Larry Kenney

Professor of Kinesiology and Physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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W. Larry Kenney, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University

Locations

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Noll Laboratory

University Park, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY24458

Identifier Type: -

Identifier Source: org_study_id

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