Feasibility of Behavioral Intervention and Guided Stepping Training Early Post-Stroke (BIG STEPS): A Pilot Randomized Trial.

OBJECTIVE: To evaluate the feasibility and preliminary effects of a behavioral intervention with guided stepping training early poststroke (BIG STEPS). DESIGN: Pilot waitlist-controlled randomized trial. SETTING: Community. PARTICIPANTS: Twenty-eight individuals with ischemic or hemorrhagic stroke (13 women [46%]; mean age: 67.8±13.3y). INTERVENTIONS: A 12-week BIG STEPS intervention to reduce sedentary time and increase daily steps was delivered to the early BIG STEPS group (n=14) and, after a 12-week waitlist period, to the delayed BIG STEPS group (n=14). Both groups received usual care. MAIN MEASURES: Feasibility, adherence, and safety. Exploratory outcomes included accelerometer-derived movement behaviors, timed walking tests, and patient-reported outcomes. RESULTS: Recruitment averaged 2.3 participants per month. Retention exceeded a priori threshold of 80% at weeks 12 and 24 (86%-93%). No intervention-related serious adverse events occurred. At week 12, the early BIG STEPS group accumulated a mean of 6534±2773 steps/day compared with 4031±2072 steps/day in the delayed BIG STEPS group. Sedentary time decreased by ∼1.4 h/d in the early group and 0.7 h/d in the delayed group. Between-group effects favored the early group for daily steps (Hedges' g=1.4) and reduced sedentary time (Hedges' g=-1.1). At week 24, outcomes converged after the delayed BIG STEPS group received the intervention. Between-group differences for timed walking tests and patient-reported outcomes were small. CONCLUSION: A behavioral intervention combined with guided stepping training early after stroke was feasible and safe, with promising preliminary effects.