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RECRUITING

NCT06565065

ImmunoBoost: The Lymphatic Osteopathic Manipulative Treatment Protocol Study

Sponsor: Western University of Health Sciences

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to determine whether osteopathic manipulative treatment (OMT) enhances immune system readiness in healthy adults compared to exercise or sham light treatment. Specifically, the goal of this study is to assess circulating immune cells and signaling molecules in the blood in response to these various treatments. It aims to compare: Complete Blood Counts (CBC) and blood immune signaling molecule levels in healthy adults in response to OMT, sham light touch, and exercise, with measurements taken at multiple time points. Researchers will compare immune blood cells and signaling molecules in response to OMT versus sham light touch and exercise within the same group of healthy adults measured at three time points for each of the three total visits. Participants will do a 15-minute OMT session, a 15-minute light sham session, or a 15-minute exercise session at each of their three separate visits (they will do one of each over the course of their 3 appointments in random order). They will have three blood draws taken at each of those three visits. They will also fill out a Global Physical Activity Questionnaire (GPAQ) survey to assess their level of physical activity throughout the study.

Official title: Lymphatic Osteopathic Manipulative Treatment Protocol for Healthy Individuals: A Crossover Self-Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-07-14

Completion Date

2025-12-30

Last Updated

2025-07-17

Healthy Volunteers

Yes

Conditions

Healthy

Interventions

PROCEDURE

Osteopathic Manipulative Treatment (OMT)

A full standardized lymphatic protocol will be performed, including thoracic inlet left and right, thoracoabdominal release, pelvic diaphragm release, pedal pump, splenic pump, and abdominal lymphatic pump. This treatment will be done by systematically working down and back up. The protocol will last a total of 12 minutes for each participant

OTHER

Sham Light Touch

A full standardized 12-minute session in which treaters will mimic various osteopathic manipulative techniques at specific anatomical locations without applying pressure or manipulation.

OTHER

Exercise Protocol

A full standardized moderate-intensity physical activity as defined by the Centers for Disease Control (CDC). Target heart rate for moderate-intensity exercise should be between 64 and 76% of maximum heart rate. To estimate age-related heart rate, subjects' age will be subtracted from 220. Then, that number will be multiplied by 75%, which will be standardized across all subjects in the study. Heart rate will be monitored with the use of an attached pulse-ox monitor. Treadmill speed will be adjusted accordingly so that each subject maintains a heart rate of 75% of their maximum heart rate. A brisk walk will be done on a flat treadmill and no incline will be utilized. Subjects will be allowed a minute of warm-up to get to the appropriate pace/target heart rate.

Inclusion Criteria: * Individuals must be 18 years or older. * Individuals must provide informed consent. * Individuals must be healthy with a BMI under 30, with no primary or secondary immune deficiency or autoimmune disease/must not be immunocompromised. * Individuals must not be using or recently have used any immune-altering medications such as corticosteroids, cyclosporin, tacrolimus, and pimecrolimus * Individuals must not have had lymphatic OMT or other physical manipulation such as acupuncture, physical therapy, chiropractic, or massage therapy in the previous four weeks before study enrollment. * Individuals must have the ability to receive OMT with lymphatic techniques. * Individuals must be able to tolerate 12 minutes of moderate physical activity. * Individuals must not be pregnant or breastfeeding. * Individuals must not have had a splenectomy or other spleen or oncologic surgery within the past 6 months. * Individuals must be infection-free for the past 6 weeks before starting the study and have not received any immunizations within the past 6 weeks. * Individuals must be willing to avoid strenuous activity at least 24 hours before each visit. * Individuals must be willing to abstain from moderate to intense activity in the 4 hours between their 2nd blood draw and their final blood draw at each of their three visits. Exclusion Criteria: * Individuals are younger than 18 years of age. * Individuals who do not provide informed consent. * Individuals with a BMI over 30, or with primary or secondary immune deficiency or autoimmune disease or is immunocompromised. * Individuals using or recently have used any immune-altering medications such as corticosteroids, cyclosporin, tacrolimus, and pimecrolimus * Individuals who have had lymphatic OMT or other physical manipulation such as acupuncture, physical therapy, chiropractic, or massage therapy in the previous four weeks before study enrollment. * Individuals who don't have the ability to receive OMT with lymphatic techniques. * Individuals who cannot tolerate 12 minutes of moderate physical activity. * Individuals who are pregnant or breastfeeding. * Individuals who have had a splenectomy or other spleen or oncologic surgery within the past 6 months. * Individuals who have had an infection in the 6 weeks before starting the study and or have received any immunizations within the past 6 weeks. * Individuals not willing to avoid strenuous activity at least 24 hours before each visit. * Individuals not willing to abstain from moderate to intense activity in the 4 hours between their 2nd blood draw and their final blood draw at each of their three visits.

Locations (2)

Western University of Health Sciences

Pomona, California, United States