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A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury
Ding K, Tarumi T, Tomoto T, Bell KR, Madden C, Dieppa M, Cullum CM, Zhang S, Zhang R
Brain Injury 2021;35(2):233-240
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To assess the feasibility of conducting an aerobic exercise training study in a community setting for individuals with traumatic brain injury (TBI) METHODS: This is a prospective, randomized, and controlled study. Nine participants (three moderate-to-severe and six mild TBI) were randomized to a community-based 3-month individualized aerobic exercise training program (AET). Seven participants (four moderate-to-severe, three mild TBI) were randomized to a stretching and toning program (SAT). Cardiorespiratory fitness (CRF) level was assessed with peak oxygen uptake (VO2peak) testing. RESULTS: After 3 months of training, the AET trended toward improved VO2peak when compared with the SAT group (8% versus -4%, p = 0.059) with a large effect size of 1.27. Only 50% of participants in the AET group completed more than 70% of the assigned exercise sessions. No adverse events were reported. Both the AET and SAT groups reported small improvements in self-reported mood symptoms, including depression, anxiety, and anger. CONCLUSIONS: It is feasible to conduct an exercise training study and improve CRF for persons with TBI in community settings with structured exercise protocols. However, exploring methods to enhance adherence is crucial for future exercise clinical trials to improve brain health in this population.

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