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 range11 Years – 18 Years

SexALL

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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

What they're measuring

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.

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.

Trial details

NCT IDNCT04688255

SponsorSeattle Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10

View on ClinicalTrials.gov More Concussion, Brain trials