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Improving Recovery and Outcomes Every Day After the ICU (IMPROVE): A Randomized Controlled Trial
Sikandar H Khan1,2, Anthony J Perkins3, Frederick W Unverzagt4
1Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN.
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.
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