Improving Recovery and Outcomes Every Day After the ICU (IMPROVE): A Randomized Controlled Trial.

OBJECTIVES

To investigate the effects of a 12-week, web-based, combined cognitive and physical training intervention on cognitive performance among ICU delirium survivors.

DESIGN

Prospective, four-arm randomized controlled trial.

SETTING

Four sites (academic, county, community ICUs).

PATIENTS

ICU adults 50 years old or older with at least one instance of ICU delirium or subsyndromal delirium.

INTERVENTIONS

Patients were randomized to one of four groups: physical exercise-cognitive training (PE-CT), physical exercise-cognitive control (PE-CC), stretching control-cognitive training (SC-CT), or stretching control-cognitive control (SC-CC).

MEASUREMENTS AND MAIN RESULTS

The primary outcome was cognitive function at 3 and 6 months after start of intervention, as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). One hundred fifty-three patients were randomized to either: PE-CT, n = 41; PE-CC, n = 41; SC-CT, n = 36; or SC-CC, n = 35. There was a significant difference on changes in RBANS z scores among the four arms (interaction term p = 0.012). The mean RBANS z scores ranged from -2.66 to +1.43 (change in RBANS z score of ± 0.5-0.6 may be clinically significant). The SC-CT group had statistically significant worsening in cognitive scores compared with the SC-CC group at 3 (mean estimated difference in change from baseline, -0.28; 95% CI, -0.53 to -0.02; p = 0.035) and 6 months (mean estimated difference in change from baseline, -0.29; 95% CI, -0.53 to -0.04; p = 0.021). Compared with the SC-CC group, the PE-CC group had statistically significant worsening in cognitive scores at 6 month (mean estimated difference in change from baseline, -0.26; 95% CI, -0.49 to -0.02; p = 0.035). There were no significant differences between groups in physical or mental quality of life, depression, or anxiety outcomes at any of the timepoints.

CONCLUSIONS

The Improving Recovery and Outcomes Every Day After the ICU (IMPROVE) trial did not result in improved cognitive, physical, mental health, or quality of life measures at 3 or 6 months. We found a drop in cognitive performance among patients receiving cognitive training from baseline to 3 months postintervention.