Ignite Creation Date:
2024-05-06 @ 12:57 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03895450
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2019-02-11
Brief Title:
Treating Persistent Post-concussion Symptoms With Exercise
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Improving Symptom Burden in Individuals With Persistent Post Concussive Symptoms A Step-wise Aerobic Exercise Trial
Status:
COMPLETED
Status Verified Date:
2023-10
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:
None
Brief Summary:
The objective of this study is to investigate an aerobic exercise program as a treatment for adults with persistent post-concussive symptoms PPCS following mild traumatic brain injury In this delayed-start trial participants will be initially randomized into either a 6-week low-impact stretching protocol or 12-week aerobic exercise protocol Following the completion of the stretching protocol participants will continue on to complete the aerobic exercise protocol in full 56 participants aged 18-65 yrs will be recruited from the Calgary Brain Injury Program CBIP including the Early Concussion Education Program at Foothills Medical Centre Calgary Pain Program University of Calgary Sports Medicine Centre acute concussion clinic and a physiotherapy clinic Tower Physio all of which are located in Calgary Alberta Canada Participants will complete an online follow up symptom questionnaires and questions regarding exercise behaviour 3 and 9 weeks post intervention
Detailed Description:
Demographic information will be collected prior to study participation and include age sex education family medical history past medical history concussion history litigious status and medication use The PAR-Q questionnaire will be completed to determine readiness for exercise by a physician Baseline questionnaires will be completed such as the Fatigue Severity Scale FSS Generalized Anxiety Disorder Scale GAD-7 Headache Intensity Scale-6 HIT-6 Patient Health QuestionnairePHQ-9 Epworth Sleepiness ScaleESS and Quality of Life After Brain InjuryQOLIBRI Rivermead Post Concussion Symptoms Questionnaire RPQ Modified Godin Leisure-Time Exercise QuestionnaireGLTQ Rapid Assessment Disuse Index RADI and Postconcusion Syndrome Checklist PCSC Pre- and post-intervention blood samples will be collected from all participants Participants will be asked to perform a tactile assessment pre- and post-intervention Sleep will be monitored using wrist-based actigraphy and a sleep diary for 3-6 daysnights prior to the intervention start and for five days following completion of the exercise protocol Pre and post magnetic resonance spectroscopy MRS will also be completed Participants will be randomized to a structured aerobic exercise protocol AEP or stretching protocol followed by aerobic exercise protocolSPAEP with a random number generator Both groups will undergo exercise testing using the Buffalo Concussion Treadmill Test to determine exercise prescription Upon completion of SP participants will continue on to the AEP and complete it in full Following the exercise protocols all questionnaires will be completed post-intervention At 3 and 9 weeks following protocol completion online follow surveys will be completed to assess symptom burden RPQ QOLIBRI HIT-6 ESS FSS along with questions regarding current exercise
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