Treating Persistent Post-concussion Symptoms With Exercise
Condition: Brain Injuries, Traumatic; Concussion, Brain; Mild Traumatic Brain Injury; Post-Concussion Syndrome
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Post-Concussion Syndrome; Wounds and Injuries
Study type: Interventional

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.
    

Intervention name(s): Aerobic Exercise Protocol; Stretching Protocol
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants randomized to AEP will be asked to exercise 30 minutes per day or until symptom exacerbation, 5 days per week either at home, outdoors or at a fitness facility of choice. The assigned exercise prescription target will be 70-80% of the maximum HR achieved during the treadmill test. HR monitors will be provided to monitor exercise intensity.; Participants will follow a stretching protocol for 30 minutes a day, 5 days a week. Individuals in the SP group will be given a booklet explaining a low-impact breathing and stretching program developed at the University of Buffalo. All stretches will explained and demonstrated by a member of the study team prior to commencement of the program. Stretches focus on lower extremity muscles. During the protocol HR should be low as to not exceed 50% of age predicted max. A HR monitor will be worn during stretching.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment