Treating Persistent Post-concussion Symptoms With Exercise
Canada52 participantsStarted 2019-05-24
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used exercise to treat persistent post-concussion symptoms — do you think an exercise-based approach would be appropriate for my situation, or are there reasons I should consider other treatments first?
2Since this trial has already been completed, have the results been published, and if so, what did they show about whether exercise actually reduced symptom burden for people with post-concussion syndrome?
3The trial measured 'change in symptom burden' — what specific symptoms were they tracking, and do my current symptoms match the kind of profile they were studying?
4Are there any risks to using exercise as a treatment after a concussion, especially if my symptoms are still ongoing, and how would we monitor whether it's helping or making things worse?
5Given that this trial is completed and not currently enrolling, are there other active trials or established clinical programs based on similar exercise approaches that might be worth exploring for my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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