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Clinical Trials/NCT06349616
NCT06349616CompletedNot Applicable

Acute and Chronic Interventions to Improve Heat Loss During Uncompensable Humid Heat Stress in Older Adults

Penn State University1 site in 1 country12 target enrollmentStarted: May 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
1
Primary Endpoint
Blood Pressure

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
65 Years to 100 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Folic acid supplementation

Experimental

5 mg/day folic acid for 6-7 weeks

Intervention: Intermittent cold-water hand and forearm immersion (Other)

Folic acid supplementation

Experimental

5 mg/day folic acid for 6-7 weeks

Intervention: No intermittent cold-water hand and forearm immersion (Other)

Control

Placebo Comparator

Cellulose placebo tablet for 6-7 weeks

Intervention: Intermittent cold-water hand and forearm immersion (Other)

Control

Placebo Comparator

Cellulose placebo tablet for 6-7 weeks

Intervention: No intermittent cold-water hand and forearm immersion (Other)

Outcomes

Primary Outcomes

Blood Pressure

Time Frame: Blood pressure for each experimental aim is recorded and reported through study completion, an average of 1 year.

Blood pressures will be taken every 10 minutes throughout each 2 hour experimental visit.

Core temperature

Time Frame: A slope of core temperature for each experimental aim is calculated and reported through study completion, an average of 1 year.

Core temperature will be monitored throughout each 2 hour experimental visit.

Heart rate

Time Frame: A slope of heart rate for each experimental aim is calculated and reported through study completion, an average of 1 year.

Heart rate will be monitored continuously throughout each 2 hour experimental visit.

Secondary Outcomes

  • Body Mass(Baseline immediately before beginning the experimental visit and then once again at the end of the 2 hour experimental visit)
  • Skin Temperature(Mean skin temperature for each experimental aim is calculated and reported through study completion, an average of 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

W. Larry Kenney

Professor of Kinesiology and Physiology

Penn State University

Study Sites (1)

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