Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565065
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
ImmunoBoost The Lymphatic Osteopathic Manipulative Treatment Protocol Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Lymphatic Osteopathic Manipulative Treatment Protocol for Healthy Individuals A Crossover Self-Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
This clinical trial is a follow-up on a recent trial demonstrating an enhanced immune response in participants who received lymphatic osteopathic manipulative treatment OMT with each of their COVID-19 mRNA vaccinations Similar immune enhancement was observed in a pilot study with OMT in conjunction with the Hepatitis B vaccine Additionally animal studies have shown that lymphatic pump OMT can cause transient increases in the movement of lymphatic fluid immune cells and signaling molecules throughout the body and bloodstream These findings were further supported by in vitro studies on fibroblasts where OMT led to significant increases in circulating cytokines There are studies that suggest that combining physical exercise with vaccination can also improve immune responses To parse out these effects observed in OMT and exercise studies and provide the mechanisms underlying the observed immune enhancements this clinical trial will be conducted
This study is designed as a crossover self-controlled comparative effectiveness randomized clinical trial A total of 30 healthy individuals who meet all inclusionexclusion criteria will be recruited Participants will then fill out a health questionnaire during the screening process to confirm their eligibility
Each participant will be randomly assigned to one of three intervention sequences to maintain blinding and control for order and sequencing effects The intervention sequences are as follows
Order 1 Day 0 OMT Week 3 Sham Week 6 Exercise
Order 2 Day 0 Sham Week 3 OMT Week 6 Exercise
Order 3 Day 0 Exercise Week 3 OMT Week 6 Sham
There will be a 3-week washout period between each intervention Participants will complete the Global Physical Activity Questionnaire GPAQ survey to identify their current level of exercise at each visit They will also be monitored for any adverse effects following each intervention
All treatment protocols will be done for a 12-minute timeframe per session Participants will have three blood draws at each visit at baseline five minutes after intervention and four hours after intervention The primary outcome measures will include cytokine levels and circulating leukocyte levels which will be compared across the different intervention sequences
This study aims to provide a deeper understanding of the mechanism by which lymphatic OMT alters the immune system It will also compare these effects to the mechanisms of exercise
This study is designed as a crossover self-controlled comparative effectiveness randomized clinical trial A total of 30 healthy individuals who meet all inclusionexclusion criteria will be recruited Participants will then fill out a health questionnaire during the screening process to confirm their eligibility
Each participant will be randomly assigned to one of three intervention sequences to maintain blinding and control for order and sequencing effects The intervention sequences are as follows
Order 1 Day 0 OMT Week 3 Sham Week 6 Exercise
Order 2 Day 0 Sham Week 3 OMT Week 6 Exercise
Order 3 Day 0 Exercise Week 3 OMT Week 6 Sham
There will be a 3-week washout period between each intervention Participants will complete the Global Physical Activity Questionnaire GPAQ survey to identify their current level of exercise at each visit They will also be monitored for any adverse effects following each intervention
All treatment protocols will be done for a 12-minute timeframe per session Participants will have three blood draws at each visit at baseline five minutes after intervention and four hours after intervention The primary outcome measures will include cytokine levels and circulating leukocyte levels which will be compared across the different intervention sequences
This study aims to provide a deeper understanding of the mechanism by which lymphatic OMT alters the immune system It will also compare these effects to the mechanisms of exercise
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None