Human Immune ResponseNCT07215338
Effects of Palmar Cooling on the Human Immune System
A study of Human Immune Response, run by Stanford University at 1 site in United States.
Trial summary
This is a research study on human exercise that will investigate the immune system response post-exercise and how it relates to Delayed Onset Muscle Soreness (DOMS), and possible causes for DOMS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immune Response
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2024to 27 Sep 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to perform two arm bicep curl of at least 35 lb as 1 repetition maximum
Who cannot join
- Autoimmune disease
- Steroid use
- On current immune-modifying treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding and Mitigating Delayed Onset Muscle Soreness (DOMS)
This is a research study on human exercise that will investigate the immune system response post-exercise and how it relates to Delayed Onset Muscle Soreness (DOMS), and possible causes for DOMS.
Blood draws (10mL) will be obtained at 5 timepoints: Baseline before intervention, day of exercise immediately following exercise, and post-exercise days 1, 2 and 4.
Point of care lactate levels obtained before and after exercise.
Subjective pain scores recorded daily starting immediately after after exercise.
- Conditions
- Human Immune Response
- Being tested
- Muscle Temperature Control
- Keywords
- Palmar Cooling, Human Immunology, Exercise Immunology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Temperature ControlOther
The intervention will be placing the palms of the hands on a water perfused pad.
| Study group | Role | What they receive |
|---|---|---|
| 30 degree celsius | Placebo comparator | Participants will be asked to complete 10 sets of bicep curls to muscle failure with 3 minute rests between sets. The placebo participants will put their palms on a water perfused pad between sets and following the last set. The pads will be perfused with 30 degree C water. Receives: Other: Muscle Temperature Control |
| 14 degree celsius | Experimental | Participants will be asked to complete 10 sets of bicep curls to muscle failure with 3 minute rests between sets. For the experimental participants they will rest their palms on a water perfused pad during each 3 minute rests and also following the last set of curls. The pads will be perfused with 12 - 14 degrees Centigrade water. curls to muscle failure.Participants will use the palmar temperature control device set to 14 degree celsius for 3 minutes. between 10 sets of bicep curls matched to control counterpart. Receives: Other: Muscle Temperature Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in phosphorylation markers in the Janus kinase/signal transducer and activator of transcription (JAK/STAT) and Toll-like Receptor (TLR)-pathway in immune cell populations
Collected at baseline from whole blood prior to exercise, day of exercise, post-exercise day 1, post-exercise day 2, post-exercise day 4
Measured: From enrollment to 5 days after the end of treatment
Secondary outcomes (2)
Change from pre-exercise baseline in point of care lactate levels
Two point of care lactate draws before and after exercise obtained in mmol/L
Measured: 1 day
Change in Pain Scores from baseline
Daily subjective pain scores recorded according to the Borg Perceived Pain Scale from 0 (no pain) to 11 (maximum pain)
Measured: From day of intervention daily for 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start28 Jun 2024
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immune ResponseStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Parallel groups
- Model description
- Control arm has palmar temperature device set to 30 degrees celsius, interventional arm has palmar temperature device set to 14 degrees celsius.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Wu Tsai Human Performance Alliance
- Responsible party
- Principal investigator, H Craig Heller, Stanford University
- Investigators
- Amy Tsai, MD, Study director, Stanford UniversityBrice Gaudilliere, MD, PhD, Principal investigator, Stanford UniversityH. Craig Heller, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215338
- Sponsor's protocol ID
- 73909
- Status last verified
- Nov 2025
- First submitted
- 8 Oct 2025
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Age, Sex, Biological information
Publications
Grahn DA, Cao VH, Heller HC. Heat extraction through the palm of one hand improves aerobic exercise endurance in a hot environment. J Appl Physiol (1985). 2005 Sep;99(3):972-8. doi: 10.1152/japplphysiol.00093.2005. Epub 2005 May 5.
PubMed 15879169
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Mitigating Delayed Onset Muscle Soreness (DOMS)
- ClinicalTrials.gov ID
- NCT07215338
- Acronym / sponsor ID
- 73909
- Conditions
- Human Immune Response
- Keywords
- Palmar Cooling, Human Immunology, Exercise Immunology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Wu Tsai Human Performance Alliance
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 10 Oct 2025 (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.
This is a research study on human exercise that will investigate the immune system response post-exercise and how it relates to Delayed Onset Muscle Soreness (DOMS), and possible causes for DOMS.
Blood draws (10mL) will be obtained at 5 timepoints: Baseline before intervention, day of exercise immediately following exercise, and post-exercise days 1, 2 and 4.
Point of care lactate levels obtained before and after exercise.
Subjective pain scores recorded daily starting immediately after after exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control arm has palmar temperature device set to 30 degrees celsius, interventional arm has palmar temperature device set to 14 degrees celsius.
| Arm | Type | Receives |
|---|---|---|
| 30 degree celsius | Placebo comparator | Other: Muscle Temperature ControlParticipants will be asked to complete 10 sets of bicep curls to muscle failure with 3 minute rests between sets. The placebo participants will put their palms on a water perfused pad between sets and following the last set. The pads will be perfused with 30 degree C water. |
| 14 degree celsius | Experimental | Other: Muscle Temperature ControlParticipants will be asked to complete 10 sets of bicep curls to muscle failure with 3 minute rests between sets. For the experimental participants they will rest their palms on a water perfused pad during each 3 minute rests and also following the last set of curls. The pads will be perfused with 12 - 14 degrees Centigrade water. curls to muscle failure.Participants will use the palmar temperature control device set to 14 degree celsius for 3 minutes. between 10 sets of bicep curls matched to control counterpart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ability to perform two arm bicep curl of at least 35 lb as 1 repetition maximum
Key exclusion criteria (3 listed)
- Autoimmune disease
- Steroid use
- On current immune-modifying treatment
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 |
|---|---|---|
| Muscle Temperature ControlThe intervention will be placing the palms of the hands on a water perfused pad. | Other | 14 degree celsius, 30 degree celsius |
Primary outcome
Mean change from baseline in phosphorylation markers in the Janus kinase/signal transducer and activator of transcription (JAK/STAT) and Toll-like Receptor (TLR)-pathway in immune cell populations
Time frame: From enrollment to 5 days after the end of treatment
Collected at baseline from whole blood prior to exercise, day of exercise, post-exercise day 1, post-exercise day 2, post-exercise day 4
2 secondary outcomes
Change from pre-exercise baseline in point of care lactate levels
Time frame: 1 day
Change in Pain Scores from baseline
Time frame: From day of intervention daily for 5 days.
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 4 Nov 2025.
- Background: PubMed 15879169Grahn DA, Cao VH, Heller HC. Heat extraction through the palm of one hand improves aerobic exercise endurance in a hot environment. J Appl Physiol (1985). 2005 Sep;99(3):972-8. doi: 10.1152/japplphysiol.00093.2005. Epub 2005 May 5.
- Individual participant dataSharing planned: Yes. Age, Sex, Biological information
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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.
Amy Tsai, MD study director
Stanford University
Brice Gaudilliere, MD, PhD principal investigator
Stanford University
H. Craig Heller, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Human Immune Response, run by Stanford 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 1 inclusion and 3 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 4 Nov 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?
Mean change from baseline in phosphorylation markers in the Janus kinase/signal transducer and activator of transcription (JAK/STAT) and Toll-like Receptor (TLR)-pathway in immune cell populations (time frame: From enrollment to 5 days after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07215338, which also lists 1 linked publication.
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 4 Nov 2025.