Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561100
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-21
Brief Title:
Treatment Optimization of Brain-injured Warfighters
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Treatment Optimization of Brain-injured Warfighters A Prescribed Sub-symptomatic Exercise Treatment
Status:
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:
TOBI-SET
Brief Summary:
Prescribed sub-symptomatic adaptable exercise treatment SAET is a potential solution that promotes recovery needs following a TBI SAET has been shown to benefit the mind and body in ways that decrease the severity and frequency of mild TBI mTBI symptoms This study aims to validate SAET as an alternative adaptable treatment or SMs with mTBI that focuses on reducing symptoms improving mental health increasing physiological functioning and ultimately returning to duty
The objective of this study is to develop a prescribed exercise treatment program for warfighters with mTBI that can be personalized for SMs needs ie medical and occupational and is adaptable to various clinical resources eg forward operating bases rural clinics and mTBI specialty programs The key question raised by this study is whether SAET is more effective than a stretching control group SCG in reducing neurobehavioral symptoms among SMs with persistent complaints following a mTBI
The objective of this study is to develop a prescribed exercise treatment program for warfighters with mTBI that can be personalized for SMs needs ie medical and occupational and is adaptable to various clinical resources eg forward operating bases rural clinics and mTBI specialty programs The key question raised by this study is whether SAET is more effective than a stretching control group SCG in reducing neurobehavioral symptoms among SMs with persistent complaints following a mTBI
Detailed Description:
The study will be a randomized clinical trial among active duty service members SMs with persistent cognitive complaints following mTBI comparing a prescribed sub-symptomatic adaptable exercise treatment SAET to an active stretching control group SCG SAETs overall effectiveness will be assessed by neurobehavioral symptom resolution Additional exploratory aims will include cognitive performance physiological adaptation and locomotion as well as functional changes in military performance These items will be addressed in the following aims
Primary Aim
To determine whether SAET is more effective than the control condition in reducing neurobehavioral symptoms among SMs with persistent complaints following mTBI Hypothesis 1 There will be a greater reduction in the Neurobehavioral Symptoms Inventory NSI from pre- to post-SAET compared to the control condition A similar finding will continue from immediate to 3 month post-SAET
Secondary Aims
Sub-aim 1 Cognitive Status To determine if SAET is effective at improving cognitive impairment among SMs with persistent complaints from mTBI Sub-hypothesis 1 There will be a greater decrease in the Global Deficit Scores GDS an overall measure of cognitive impairment post SAET in comparison to the control condition
Sub-aim 2 Physiological Adaptation To measure physiological adaptation associated with SAET compared to the control condition Sub-hypothesis 2 SAET will be associated with improved cerebrovascular blood flow regulation as measured by Transcranial Doppler and improved cardiovascular function as measured by changes in heart rate variability HRV and estimated maximal oxygen consumption est VO2 max compared to the control condition
Sub-aim 3 Warfighter Performance To determine if SAET participants will have improved locomotion and a higher level of occupational performance compared to the control condition Sub-hypothesis 3 SAET participants will have improved locomotion and physical performance based on the Marine Corps Combat Fitness TestCFT and higher ratings of occupational performance based on supervisor ratings on the Checklist of Military Activities of Daily Living M-ADL after completion of treatment and 3 months post-treatment compared to the control condition
Primary Aim
To determine whether SAET is more effective than the control condition in reducing neurobehavioral symptoms among SMs with persistent complaints following mTBI Hypothesis 1 There will be a greater reduction in the Neurobehavioral Symptoms Inventory NSI from pre- to post-SAET compared to the control condition A similar finding will continue from immediate to 3 month post-SAET
Secondary Aims
Sub-aim 1 Cognitive Status To determine if SAET is effective at improving cognitive impairment among SMs with persistent complaints from mTBI Sub-hypothesis 1 There will be a greater decrease in the Global Deficit Scores GDS an overall measure of cognitive impairment post SAET in comparison to the control condition
Sub-aim 2 Physiological Adaptation To measure physiological adaptation associated with SAET compared to the control condition Sub-hypothesis 2 SAET will be associated with improved cerebrovascular blood flow regulation as measured by Transcranial Doppler and improved cardiovascular function as measured by changes in heart rate variability HRV and estimated maximal oxygen consumption est VO2 max compared to the control condition
Sub-aim 3 Warfighter Performance To determine if SAET participants will have improved locomotion and a higher level of occupational performance compared to the control condition Sub-hypothesis 3 SAET participants will have improved locomotion and physical performance based on the Marine Corps Combat Fitness TestCFT and higher ratings of occupational performance based on supervisor ratings on the Checklist of Military Activities of Daily Living M-ADL after completion of treatment and 3 months post-treatment compared to the control condition
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