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FLOW Trial - The effect of fluoxetine combined with exercise on motor recovery after stroke: an RCT
Mark T Bayley1, Josie Chundamala1, Evan Foster1
1Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.
Objective:
To evaluate whether the combination of fluoxetine and therapeutic exercise enhances lower extremity motor recovery after stroke.
Design:
Randomized, double-blind, placebo controlled clinical trial.
Setting:
Eight sites from the CanStroke Recovery Trials Platform (www.canadianstroke.ca).
Participants:
Individuals 25 years of age or older, 2 to 12 months post-stroke, with lower extremity hemiparesis.
Intervention:
Participants were randomized (1:1) to either 20 mg daily of fluoxetine or placebo. All participants received 12-weeks of intense task-specific exercise.
Main Outcome Measure:
The primary outcome measure was lower extremity motor function as measured using the Fugl-Meyer Assessment of Lower Extremity (FMA-LE) immediately following the 12-week exercise program. Secondary outcomes included the 6-Minute Walk Test (6MWT) and the Patient Health Questionnaire-9 (PHQ-9).
Results:
55 participants were recruited and completed the primary outcome measure (30.9% female, average age: 61.0 [SD 11.0], average days post-stroke: 204.1 [SD 96.0]), with 25 participants receiving fluoxetine and exercise, and 30 in the placebo and exercise group. The baseline adjusted mean difference in post-exercise FMA-LE score between the fluoxetine and placebo groups was 0.47 (95% CI: [-1.36,2.3]; p=0.61). Participants in both groups demonstrated a clinically meaningful increase in 6MWT scores that was maintained for at least 6 months beyond the end of the intervention.
Conclusions:
Fluoxetine plus exercise did not demonstrate any additional improvement in lower extremity motor recovery compared to placebo and exercise in participants 2-12 months post-stroke. This study did not meet its planned sample size due to recruitment issues primarily attributed to the COVID-19 pandemic. Given that participants made clinically meaningful improvements in walking, this study highlights the importance of exercise beyond the traditional subacute post-stroke period. Future studies should utilize a "no exercise" control group to account for natural recovery to accurately interpret the results from the exercise protocol.
