Effects of Palmar Cooling on the Human Immune System

NCT07215338 | Completed

• 1 other identifier: 73909
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Palmar Cooling; Human Immunology; Exercise Immunology

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to 5 days after the end of treatment

Secondary Outcomes (2)

• Change from pre-exercise baseline in point of care lactate levels

  1 day

• Change in Pain Scores from baseline

  From day of intervention daily for 5 days.

Study Arms (2)

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.

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.

Other: Muscle Temperature Control

Interventions

Muscle Temperature Control OTHER

The intervention will be placing the palms of the hands on a water perfused pad.

14 degree celsius; 30 degree celsius

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Ability to perform two arm bicep curl of at least 35 lb as 1 repetition maximum

You may not qualify if:

• Autoimmune disease
• Steroid use
• On current immune-modifying treatment

Sponsors & Collaborators

• Stanford University: lead
• Wu Tsai Human Performance Alliance: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 15879169 BACKGROUND

Study Officials

• Amy Tsai, MD

  Stanford University

  STUDY DIRECTOR

• Brice Gaudilliere, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• H. Craig Heller, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Control arm has palmar temperature device set to 30 degrees celsius, interventional arm has palmar temperature device set to 14 degrees celsius.

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 10, 2025
• Study Start: June 28, 2024
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: November 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data is available now and will remain available.
• Access Criteria: Access through RedCap

Locations

US (1)