Ignite Creation Date:
2024-07-17 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494592
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-25
Brief Title:
The Exercise and Concussion Health Study
Sponsor:
Northeastern University
Organization:
Northeastern University
Study Overview
Official Title:
The Exercise and Concussion Health Study TECHS
Status:
RECRUITING
Status Verified Date:
2024-07
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:
TECHS
Brief Summary:
This study aims to investigate the effect of two different physical exercise interventions on the brain cognition and patient reported outcomes following a mild traumatic brain injury mTBI in community-dwelling adults
Physical exercise as an intervention for mTBI has great potential yet there is limited high-quality evidence of its effect Additionally while standardized exercise protocols for sport-related concussion exist a similar program is not available to members of the general public who have suffered a mTBI This study therefore aims to test the effect of a 3-month exercise protocol either focusing on balance or aerobic exercises The results from the study may lead to advances in evidenced-based mTBI management and provide clinicians with an effective intervention that can improve brain and cognitive recovery after mTBI
Physical exercise as an intervention for mTBI has great potential yet there is limited high-quality evidence of its effect Additionally while standardized exercise protocols for sport-related concussion exist a similar program is not available to members of the general public who have suffered a mTBI This study therefore aims to test the effect of a 3-month exercise protocol either focusing on balance or aerobic exercises The results from the study may lead to advances in evidenced-based mTBI management and provide clinicians with an effective intervention that can improve brain and cognitive recovery after mTBI
Detailed Description:
This is a 12-week two arm pilot randomized control trial comparing two types of exercise interventions Both groups will complete three 30-minute remote exercise sessions weekly via Zoom delivered by a trained interventionist and supervised by a dedicated safety officer Participants will be randomly assigned to either aerobic or balance based exercise for the duration of the study Participants will sign informed consent in person during a baseline visit where measures of brain magnetic resonance imaging MRI and electroencephalography EEG cognition patient reported outcomes and lifestyle questionnaires are collected Participants will repeat this session in-person at the end of the 12-week intervention Participants will wear a wrist-worn Actigraph for 7 consecutive days at 3 time points throughout the intervention period once each month to collect daily physical activity levels and sleep metrics Both interventions will be individualized and progressive in terms of intensity and difficulty The exercise interventions sessions will be thresholded at a heart rate of 80 symptom threshold assessed at baseline using a modified cycle and fitness test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None