Viewing Study NCT06380179



Ignite Creation Date: 2024-05-06 @ 8:27 PM
Last Modification Date: 2024-10-26 @ 3:27 PM
Study NCT ID: NCT06380179
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-26
First Post: 2024-03-13

Brief Title: Photomedicine Project 14 PBMT for Performance Enhancement in SOF
Sponsor: Musculoskeletal Injury Rehabilitation Research for Operational Readiness MIRROR
Organization: Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Study Overview

Official Title: Assessing the Impact of Post-Exercise Photobiomodulation Application on Performance Recovery and Behavioral State in Trained Special Operator Population
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SOF
Brief Summary: Special Operations Forces SOF train continually to maintain peak performance Thus they are nearly always in a state of recovery and in need of noninvasive therapies to address the taxing workload Photobiomodulation therapy PBMT is a noninvasive treatment where a low-level laser is applied to the body to enhance healing recovery and performance Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning THOR3 provides a consistent avenue for implementation of PBMT as a modality Studies in athletes have shown performance and recovery benefits with pre-and post-workout focal application of PBMT While there is less evidence on the potential cognitivebehavioral effects of a systematic application of PBMT self-reported fatigue has also been found to be significantly lower in groups with focal PBMT application as compared to placebo Further PBMT research in healthy military tactical athletes is limited PBMT may be a promising tool for enhancing physical performance by accelerating musculoskeletal and psychological recovery in the SOF population The investigators aim to study the physiologic and behavioral effects of PBMT application post-exercise on performance in SOF Operators

The Intent The investigators propose to conduct a single-blinded randomized-control trial with sham control to investigate the effectiveness of providing PBMT post physical training in a SOF population

The specific aims of this study are to

1 Analyze and describe the physiologic effects if any of PBMT application post-exercise in Special Forces Operators undergoing coach-led training
2 Analyze and describe the behavioral effects if any of PBMT application post-exercise in Special Forces Operators undergoing coach-led training
3 Evaluate the overall clinical utility of focal PBMT subsequent to physical training in a US Army SOF tactical athlete population
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None