Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562127
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
TBI Rehabilitation and Activation in Veterans
Sponsor:
None
Organization:
None
Study Overview
Official Title:
TBI Rehabilitation and Activation in Veterans TRAIN-Vets
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:
TRAIN-Vets
Brief Summary:
This trial will evaluate the impact of a multicomponent program TBI Rehabilitation and Activation in Veterans TRAIN-Vets on improving cognitive function over an 8-month trial period in older Veterans with traumatic brain injury TBI Older Veterans with a history of TBI and subjective cognitive complaints will be enrolled and randomly assign to either the TRAIN-Vets intervention consisting of aquatic-based exercise training cognitive training and lifestyle coaching or the Health Education Control where they will receive educational materials about brain health and healthy lifestyles
Detailed Description:
The purpose of the proposed trial is to evaluate the impact of a multicomponent training program TRAIN-Vets on improving cognitive function and other outcomes over an 8-month period in older Veterans with TBI and cognitive complaints The primary aim of the trial is to evaluate the efficacy of the TRAIN-Vets intervention to improve cognitive function in Veterans with TBI Secondary aims of the proposed research are to evaluate the efficacy of TRAIN-Vets to improve 1 individual cognitive domain scores 2 psychological and social measures sleep mood social and community engagement and life satisfaction and 3 physical fitness
The investigators will randomize 120 older Veterans with TBI and cognitive complaints aged 50 or older to TRAIN-Vets or Health Education Control HEC Participants randomized to the TRAIN-Vets group will engage in aquatic-based exercise training and cognitive training combined with lifestyle coaching related to their brain health risk factors This intervention entails 6 months of thrice-weekly aquatic-based exercise training at Veterans Affairs Palo Alto Health Care System VAPAHCS After completion of the 6-months of exercise training Veterans in this condition will participate in 2 months of weekly structured on-line cognitive training focused on improvement of executive function and attention based out of the San Francisco Veterans Affairs Health Care System SFVAHCS Over the 8 months Veterans in TRAIN-Vets will also participate virtually in monthly lifestyle coaching based at SFVHCS focused on improving other risk factors and symptoms Participants in the HEC group will be mailed educational materials about brain health and healthy lifestyles throughout the 8 months HEC participants will be contacted monthly through phone calls to check in and maintain interest All participants will complete a phone screening baseline in person and virtual visits and follow-up visits with blinded assessors to assess outcomes at approximately 6 and 8 months
The investigators will randomize 120 older Veterans with TBI and cognitive complaints aged 50 or older to TRAIN-Vets or Health Education Control HEC Participants randomized to the TRAIN-Vets group will engage in aquatic-based exercise training and cognitive training combined with lifestyle coaching related to their brain health risk factors This intervention entails 6 months of thrice-weekly aquatic-based exercise training at Veterans Affairs Palo Alto Health Care System VAPAHCS After completion of the 6-months of exercise training Veterans in this condition will participate in 2 months of weekly structured on-line cognitive training focused on improvement of executive function and attention based out of the San Francisco Veterans Affairs Health Care System SFVAHCS Over the 8 months Veterans in TRAIN-Vets will also participate virtually in monthly lifestyle coaching based at SFVHCS focused on improving other risk factors and symptoms Participants in the HEC group will be mailed educational materials about brain health and healthy lifestyles throughout the 8 months HEC participants will be contacted monthly through phone calls to check in and maintain interest All participants will complete a phone screening baseline in person and virtual visits and follow-up visits with blinded assessors to assess outcomes at approximately 6 and 8 months
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