BackgroundSwallowing dysfunction after stroke is common, but there is little reliable evidence for how the disorder should be managed. This study compared standard low-intensity and high-intensity behavioural interventions with usual care for dysphagia.Methods306 patients with clinical dysphagia admitted to hospital with acute stroke were randomly assigned to receive usual care (n=102), prescribed by the attending physician; standard low-intensity intervention (n=102), comprising swallowing compensation strategies and diet prescription three times weekly for up to a month; or standard high-intensity intervention and dietary prescription (n=102), at least daily for up to a month. The primary outcome measure was survival free of an abnormal diet at 6 months. Analysis was done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00257764.Findings60 patients died and three patients were lost to follow up before the 6-month analysis. Of patients randomly allocated usual care, 56% (57/102) survived at 6 months free of an abnormal diet compared with 67% (136/204) allocated standard swallowing therapy (relative risk 1·19, 95% CI 0·98–1·45). Standard swallowing therapy was associated with a non-significant trend toward a reduction in death (0·80, 0·5–1·3), institutionalisation (0·69, 0·4–1·1), and dependency (1·05, 0·8–1·3); a significant reduction in swallowing-related medical complications (0·73, 0·6–0·9), chest infection (0·56, 0·4–0·8), and death or institutionalisation (0·73, 0·55–0·97); and a significant rise in the proportion of patients regaining swallowing function (1·41, 1·03–1·94) by 6 months. Compared with usual care and low-intensity therapy, high-intensity therapy was associated with an increased proportion of patients who returned to a normal diet (p=0·04) and recovered swallowing (p=0·02) by 6 months.InterpretationThese data show a consistent trend towards more favourable outcomes in dysphagic stroke patients who are assigned a standard programme of early behavioural swallowing intervention, including active therapeutic approaches and dietary modification.