AgingNCT06349616
Cooling Strategies for Older Adults in the Heat
A study testing Intermittent cold-water hand and forearm immersion and No intermittent cold-water hand and forearm immersion in people with Aging, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Intermittent cold-water hand and forearm immersion and No intermittent cold-water hand and forearm immersion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 21 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adults aged 65 and older
- English proficiency
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Noll Laboratory
University Park, Pennsylvania, 16802
About this study
Official title: Acute and Chronic Interventions to Improve Heat Loss During Uncompensable Humid Heat Stress in Older Adults
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Intermittent cold-water hand and forearm immersion, No intermittent cold-water hand and forearm immersion
- Keywords
- Aging, Thermoregulation, Heat Stress
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent cold-water hand and forearm immersionOther
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 immersionOther
Participants will be seated at rest in a hot and humid environment.
| Study group | Role | What they receive |
|---|---|---|
| Folic acid supplementation | Experimental | 5 mg/day folic acid for 6-7 weeks Receives: Other: Intermittent cold-water hand and forearm immersion; Other: No intermittent cold-water hand and forearm immersion |
| Control | Placebo comparator | Cellulose placebo tablet for 6-7 weeks Receives: Other: Intermittent cold-water hand and forearm immersion; Other: No intermittent cold-water hand and forearm immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core temperature
Core temperature will be monitored throughout each 2 hour experimental visit.
Measured: A slope of core temperature for each experimental aim is calculated and reported through study completion, an average of 1 year.
Heart rate
Heart rate will be monitored continuously throughout each 2 hour experimental visit.
Measured: A slope of heart rate for each experimental aim is calculated and reported through study completion, an average of 1 year.
Blood Pressure
Blood pressures will be taken every 10 minutes throughout each 2 hour experimental visit.
Measured: Blood pressure for each experimental aim is recorded and reported through study completion, an average of 1 year.
Secondary outcomes (2)
Body Mass
Body weight measured on a scale
Measured: Baseline immediately before beginning the experimental visit and then once again at the end of the 2 hour experimental visit
Skin Temperature
Average mean skin temperature
Measured: Mean skin temperature for each experimental aim is calculated and reported through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 May 2024
- Primary completion21 Jul 2025
- Study completion21 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects participate in 4 experiments, 2 for each treatment (folic acid supplementation and placebo). The order of treatment is random.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W. Larry Kenney, Penn State University
- Investigators
- W. Larry Kenney, Ph.D., Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349616
- Sponsor's protocol ID
- STUDY24458
- Status last verified
- Jul 2025
- First submitted
- 19 Mar 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Interventions to Improve Heat Loss During Uncompensable Humid Heat Stress in Older Adults
- ClinicalTrials.gov ID
- NCT06349616
- Acronym / sponsor ID
- STUDY24458
- Conditions
- Aging
- Keywords
- Aging, Thermoregulation, Heat Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 21 Jul 2025 (actual)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects participate in 4 experiments, 2 for each treatment (folic acid supplementation and placebo). The order of treatment is random.
| Arm | Type | Receives |
|---|---|---|
| Folic acid supplementation | Experimental | Other: Intermittent cold-water hand and forearm immersion, Other: No intermittent cold-water hand and forearm immersion5 mg/day folic acid for 6-7 weeks |
| Control | Placebo comparator | Other: Intermittent cold-water hand and forearm immersion, Other: No intermittent cold-water hand and forearm immersionCellulose placebo tablet for 6-7 weeks |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Adults aged 65 and older
- English proficiency
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent cold-water hand and forearm immersionParticipants 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. | Other | Control, Folic acid supplementation |
| No intermittent cold-water hand and forearm immersionParticipants will be seated at rest in a hot and humid environment. | Other | Control, Folic acid supplementation |
Primary outcome
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.
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.
2 secondary outcomes
Body Mass
Time frame: Baseline immediately before beginning the experimental visit and then once again at the end of the 2 hour experimental visit
Skin Temperature
Time frame: Mean skin temperature for each experimental aim is calculated and reported through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. Larry Kenney, Ph.D. principal investigator
The Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent cold-water hand and forearm immersion and No intermittent cold-water hand and forearm immersion in people with Aging, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.