Mobile Subthreshold Exercise Program for Concussion--R01

Summary

Participation Requirements

Description

The investigators will recruit n=200 youth 11-18 years old with PPCS. Youth will be randomized to 6 weeks of either usual care plus M-STEP (intervention) or usual care plus stretching (control). Youth in M-STEP will be coached through gradual increases in intensity and duration of rehabilitative exe...

The investigators will recruit n=200 youth 11-18 years old with PPCS. Youth will be randomized to 6 weeks of either usual care plus M-STEP (intervention) or usual care plus stretching (control). Youth in M-STEP will be coached through gradual increases in intensity and duration of rehabilitative exercise via weekly video conferencing (Zoom) and will use Fitbits to guide their progress. Youth in the stretching group will act as attention controls. All youth will complete research-grade measures at multiple time points. Youth will be followed for a total of 6 months. Data will be analyzed using mixed effects models to examine differences between experimental groups in the primary outcome, trajectory of concussive symptoms, and the secondary outcome, changes over time in health-related quality of life, on an intention-to-treat basis. Potential mediators of the treatment effect will also be examined, including fear-avoidance of concussive symptoms and MVPA, and explore the impact of factors such as patient sex and parental protective behaviors. The investigators thus assert the following hypotheses: Hypothesis 1: M-STEP youth will have more rapid declines in HBI and improvement in PedsQL compared to control youth Hypothesis 2: M-STEP youth will have greater increases in MVPA over time than control youth, and these increases will predict more rapid improvement in HBI and PedsQL. Hypothesis 3: M-STEP youth will have steeper declines in fear-avoidance compared to control youth, and these declines will predict more rapid improvement in HBI and PedsQL. IMPACT: The proposed study will definitively answer the question of whether a mobile sub-threshold exercise program (M-STEP) improves outcomes for youth with PPCS. It will also provide essential information about both the long-term impact of this intervention and potential mediators as well as biopsychosocial factors that influence treatment response. The study design uses a rigorous protocolized smartphone administered mHealth intervention that will be readily reproducible and generalizable to the majority of youth with PPCS. If successful, this will be one of the few evidenced-based interventions available to treat youth with PPCS.

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