ACT-ICU Study: Activity and Cognitive Therapy in the Intensive Care Unit

The long-term consequences of critical illness and intensive care unit (ICU) hospitalization
in ICU survivors are profound and include cognitive, physical, and functional impairments.
The purpose of this study is to pilot test a multi-component, cognitive and physical
rehabilitation program beginning in the ICU, combined with a 12-week home-based cognitive
rehabilitation program following hospital discharge to determine whether participation in a
rehabilitation program will result in improved outcomes among ICU survivors. The study will
rely on a randomized controlled clinical trial design, with patients assigned to one of
three groups: a "usual care" control group, an early physical activity group (without
cognitive therapy), or an early cognitive therapy and physical activity group. All
individuals in the intervention groups will receive protocolized physical therapy while
hospitalized. In addition, individuals in the early cognitive therapy and physical activity
group will receive cognitive therapy starting in the ICU and continuing for 12 weeks once a
patient leaves the hospital. In-home visits will occur every other week during the 12-week
intervention period.

The study's primary outcome is executive functioning (e.g. ability to plan, organize,
multi-task) at 3-months following hospital discharge as measured by the Tower Test, a
psychometric tool evaluating executive abilities. This has been chosen due to the fact that
available research points to the presence of significant deficits in executive functioning
among ICU survivors. Secondary outcomes include global cognitive function, physical function
and Health Related Quality of Life by assessing scores on the following measures: Katz's
ADL, Functional Activities Questionnaire, AD8, Short-Informant Questionnaire of Cognitive
Decline in the Elderly, Clinical Dementia Rating Scale (if performed), Timed Up & Go test,
Mini-Mental State Exam, Dysexecutive Questionnaire, Activities-Specific Balance Confidence
Scale, Behavior Rating Inventory of Executive Function, Behavior Pain Inventory, Trails A &
B test, Repeatable Battery for Assessment of Neuropsychological Status, General Employment
Questionnaire, Beck Depression Inventory II, Post-traumatic stress checklist, Short Form 36,
Canadian Study of Health and Aging and patient weight, and Tower Test score at 12 month
follow-up. We will also track readmission to the hospital and admission to a nursing home or
skilled rehabilitation facility as secondary outcomes during the 12-month follow-up period.
The study duration will include 1 year of enrollment and 1 year for study completion
following enrollment of the final patient.

Inclusion Criteria:

- Adult patients admitted to the medical or surgical ICU who are receiving treatment
for respiratory failure, cardiogenic shock, hemorrhagic shock, and/or septic shock.

Exclusion Criteria:

- Moderate to severe dementia on ICU admission based on a standardized surrogate
assessment (as this would prohibit patients from functioning independently at home);

- Moderate or severe physical dysfunction that precludes performance of independent
activities of daily living based on a standardized surrogate assessment;

- Live greater than 120 miles from Nashville;

- Blind, deaf, or unable to speak English;

- Prisoners;

- Homelessness and no secondary contact person available