OBJECTIVE: To describe the methodology and report primary outcomes of an exploratory randomized clinical trial (RCT) of aerobic training for management of prolonged symptoms after a mild traumatic brain injury (mTBI) in adolescents. SETTING: Outpatient research setting. PARTICIPANTS: Thirty adolescents between the ages of 12 and 17 years who sustained a mTBI and had between 4 and 16 weeks of persistent symptoms. DESIGN: Partially blinded, pilot RCT of subsymptom exacerbation aerobic training compared with a full-body stretching program. MAIN MEASURES: The primary outcome was postinjury symptom improvement assessed by the adolescent's self-reported Post-Concussion Symptom Inventory (PCSI) repeated for at least 6 weeks of the intervention. Parent-reported PCSI and adherence are also described. RESULTS:Twenty-two percent of eligible participants enrolled in the trial. Repeated-measures analysis of variance via mixed-models analysis demonstrated a significant group × time interaction with self-reported PCSI ratings, indicating a greater rate of improvement in the subsymptom exacerbation aerobic training group than in the full-body stretching group (F = 4.11, P = .044). Adherence to the home exercise programs was lower in the subsymptom exacerbation aerobic training group compared with the full-body stretching group (mean [SD] times per week = 4.42 [1.95] vs 5.85 [1.37], P < .0001) over the duration of the study. CONCLUSION: Findings from this exploratory RCT suggest subsymptom exacerbation aerobic training is potentially beneficial for adolescents with persistent symptoms after an mTBI. These findings and other recent research support the potential benefit of active rehabilitation programs for adolescents with persistent symptoms after an mTBI. Larger replication studies are needed to verify findings and improve generalizability. Future work should focus on determining the optimal type, timing, and intensity of active rehabilitation programs and characteristics of individuals most likely to benefit.
RCT Entities:
OBJECTIVE: To describe the methodology and report primary outcomes of an exploratory randomized clinical trial (RCT) of aerobic training for management of prolonged symptoms after a mild traumatic brain injury (mTBI) in adolescents. SETTING:Outpatient research setting. PARTICIPANTS: Thirty adolescents between the ages of 12 and 17 years who sustained a mTBI and had between 4 and 16 weeks of persistent symptoms. DESIGN: Partially blinded, pilot RCT of subsymptom exacerbation aerobic training compared with a full-body stretching program. MAIN MEASURES: The primary outcome was postinjury symptom improvement assessed by the adolescent's self-reported Post-Concussion Symptom Inventory (PCSI) repeated for at least 6 weeks of the intervention. Parent-reported PCSI and adherence are also described. RESULTS: Twenty-two percent of eligible participants enrolled in the trial. Repeated-measures analysis of variance via mixed-models analysis demonstrated a significant group × time interaction with self-reported PCSI ratings, indicating a greater rate of improvement in the subsymptom exacerbation aerobic training group than in the full-body stretching group (F = 4.11, P = .044). Adherence to the home exercise programs was lower in the subsymptom exacerbation aerobic training group compared with the full-body stretching group (mean [SD] times per week = 4.42 [1.95] vs 5.85 [1.37], P < .0001) over the duration of the study. CONCLUSION: Findings from this exploratory RCT suggest subsymptom exacerbation aerobic training is potentially beneficial for adolescents with persistent symptoms after an mTBI. These findings and other recent research support the potential benefit of active rehabilitation programs for adolescents with persistent symptoms after an mTBI. Larger replication studies are needed to verify findings and improve generalizability. Future work should focus on determining the optimal type, timing, and intensity of active rehabilitation programs and characteristics of individuals most likely to benefit.
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