Mobile Subthreshold Exercise Program for Concussion--R01 (NCT04688255) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Mobile Subthreshold Exercise Program for Concussion--R01
United States200 participantsStarted 2021-03-22
Plain-language summary
Approximately 1.9 million youth sustain a concussion each year, and up to 30% experience persistent post-concussive symptoms (PPCS) such as headache, dizziness, and difficulty focusing that continue for weeks or months. PPCS results in greater utilization of sub-specialty care and can impact immediate and long-term social development, cognitive function and academic success. Previous recommendations for treating PPCS have focused on cognitive and physical rest, but more recently guidelines have shifted based on new research suggesting the benefit of rehabilitative exercise for PPCS. The rationale behind using exercise to treat youth with concussion is that gradually increasing physical activity facilitates return to full function. Rehabilitative exercise has since become one of the most common approaches to treating youth with PPCS, but access is challenging since most programs require weekly centralized visits with a concussion specialist. To bridge this gap, the investigators developed a telehealth-delivered approach to treat PPCS, utilizing physical activity trackers (Fitbits) and weekly video conferences with trained research staff. They then conducted a series of pilot studies with this approach, finding excellent feasibility, acceptability, and evidence for more rapid declines in concussive symptoms compared to controls. The investigators also found preliminary evidence that mechanisms behind this intervention may stem from both physiologic processes due to increased moderate-to-vigorous physical activity (MVPA) and psychologic processes such as reducing fear- avoidance of concussive symptoms. They now propose a fully-powered randomized controlled trial (RCT) to asses the efficacy of the "Mobile Subthreshold Exercise Program" (M-STEP) for treating youth with PPCS.
Who can participate
Age range
11 Years – 18 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:
* Youth 11-18 years
* Concussion occurring 1 week to 12 months prior to the start of the study and diagnosed by a clinician trained in concussion management consistent with the 2017 Berlin consensus definition of concussion ("A traumatic brain injury, induced by biomechanical forces")
* Persistent post-concussive symptoms as defined by the presence of at least 3 concussive symptoms rated at least 2 or greater on the Health and Behavior Inventory (HBI) and a total score of at least 10
* Can be located anywhere as all study procedures are remote
Exclusion Criteria:
* Youth not fluent in English or at least one Parent not fluent in English or Spanish
* Other injuries or medical conditions in addition to concussion that have prompted a clinician to recommend against MVPA, such as concerning abnormalities on routine brain imaging
* Youth who indicate that they are completing an average of 30 minutes per day or greater of physical activity that increases their heart rate (indicative of a minimal need for a physical activity intervention)
* Youth who have previously engaged with a Physical Therapist to increase aerobic activity
* Youth who have been fully cleared for sport
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 is testing a mobile subthreshold exercise program for concussion recovery in kids — is my child's current symptom level and activity restriction a good match for what this type of exercise-based approach is designed for?
2Since this trial is no longer enrolling new participants, are there similar exercise-based concussion programs or trials that are still open that my child might be considered for instead?
3The trial is measuring concussion symptoms using a 21-item scale and quality of life — how would we track whether my child is actually improving on those same kinds of measures if we pursued a subthreshold exercise approach outside of the trial?
4This is a Phase NA study, meaning it's more about testing the program's design and feasibility than proving it works — does that change how confident you'd feel recommending exercise-based treatment for my child right now, compared to more established options?
5My child may have persistent post-concussion symptoms — how does a subthreshold exercise program work differently than rest or standard care, and is there any risk that exercise could make their headaches or symptoms worse?
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
Concussive symptoms (Health Behavior Inventory, HBI)--youth, a 21 item 0-3 likert scale with higher scores indicating more severe symptoms
Timeframe: Baseline, weekly during the intervention (x6 weeks), 3 months and 6 months.
2
Pediatric Quality of Life (PEDsQL, parent and youth), a 23 item 0-4 likert scale that is scaled to 0-100 with higher scores indicating better function
Timeframe: Baseline, 6 weeks, 3 months and 6 months.