Clinical trial NCT03895450: Treating Persistent Post-concussion Symptoms With Exercise
Official title: Improving Symptom Burden in Individuals With Persistent Post Concussive Symptoms: A Step-wise Aerobic Exercise Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries, Traumatic
Concussion, Brain
Mild Traumatic Brain Injury
Post-Concussion Syndrome
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Hotchkiss Brain Institute, University of Calgary
First posted: 2019-03-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 Questionnaire(PHQ-9), Epworth Sleepiness Scale(ESS) and Quality of Life After Brain Injury(QOLIBRI), Rivermead Post Concussion Symptoms Questionnaire (RPQ), Modified Godin Leisure-Time Exercise Questionnaire(GLTQ), 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 days/nights 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 protocol(SP+AEP) 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of mild traumatic brain injury (mTBI) based on the American Congress of Rehabilitation Medicine (ACRM) criteria.
* mTBI occurrence from 3 months to 5 years from study start date
* Diagnosis of persistent post-concussion symptoms based on the ICD-10 criteria.
* Cleared for physical activity based on The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) by treating physician
* exercise intolerance (inability to exercise at pre-injury intensity/duration due to acute presentation of symptoms)

Exclusion Criteria:

* past medical history of neurological disorders (i.e., Parkinson's disease, neuromuscular disorders)
* contraindications to MRI
* cardiopulmonary disorder
* chronic musculoskeletal condition
* psychiatric disorder other than depression and/or anxiety (i.e., schizophrenia, bipolar disorder)
* cancer
* pregnancy

Primary outcomes:
measure: Change in symptom burden
timeFrame: Repeated measure: Pre-intervention, after 6-weeks of SP/AEP, after 12-weeks of AEP, 3-weeks post-AEP, 9-weeks post-AEP
Secondary outcomes:
measure: Change in sleep duration
timeFrame: Repeated measure: Pre-intervention, after 6-weeks of SP/AEP, after 12-weeks of AEP
measure: Change in daytime sleepiness
timeFrame: Repeated measure: Pre-intervention, after 6-weeks of SP/AEP, after 12-weeks of AEP, 3-weeks post-AEP, 9-weeks post-AEP
measure: Change in blood derived neurotrophic factor (BDNF)
timeFrame: Repeated measure: Pre-intervention, after 6-weeks of SP/AEP, after 12-weeks of AEP
measure: Change in cytokine profile
timeFrame: Repeated measure: Pre-intervention, after 6-weeks of SP/AEP, after 12-weeks of AEP
measure: Change in telomere length (TL)
timeFrame: Repeated measure: Pre-intervention, after 6-weeks of SP/AEP, after 12-weeks of AEP
measure: Change in fatigue
timeFrame: Repeated measure: Pre-intervention, after 6-weeks of SP/AEP, after 12-weeks of AEP, 3-weeks post-AEP, 9-weeks post-AEP
measure: Change in anxiety
timeFrame: Repeated measure: Pre-intervention, after 6-weeks of SP/AEP, after 12-weeks of AEP
measure: Change in function related to headaches
timeFrame: Repeated measure: Pre-intervention, after 6-weeks of SP/AEP, after 12-weeks of AEP, 3-weeks post-AEP, 9-weeks post-AEP
measure: Change in depression
timeFrame: Repeated measure: Pre-intervention, after 6-weeks of SP/AEP, after 12-weeks of AEP
measure: MRS quantification of GABA/Glutathione
timeFrame: Repeated measure: Pre-intervention, after 6-weeks of SP/AEP, after 12-week of AEP
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University Of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Chantel T Debert, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
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