A combined early cognitive and physical rehabilitation program for people who are critically ill: the activity and cognitive therapy in the intensive care unit (ACT-ICU) trial

Abstract

Background: In the coming years, the number of survivors of critical illness is expected to increase. These survivors frequently develop newly acquired physical and cognitive impairments. Long-term cognitive impairment is common following critical illness and has dramatic effects on patients' abilities to function autonomously. Neuromuscular weakness affects similar proportions of patients and leads to equally profound life alterations. As knowledge of these short-term and long-term consequences of critical illness has come to light, interventions to prevent and rehabilitate these devastating consequences have been sought. Physical rehabilitation has been shown to improve functional outcomes in people who are critically ill, but subsequent studies of physical rehabilitation after hospital discharge have not. Post-hospital discharge cognitive rehabilitation is feasible in survivors of critical illness and is commonly used in people with other forms of acquired brain injury. The feasibility of early cognitive therapy in people who are critically ill remains unknown.

Objective: The purpose of this novel protocol trial will be to determine the feasibility of early and sustained cognitive rehabilitation paired with physical rehabilitation in patients who are critically ill from medical and surgical intensive care units.

Design: This is a randomized controlled trial.

Setting: The setting for this trial will be medical and surgical intensive care units of a large tertiary care referral center.

Patients: The participants will be patients who are critically ill with respiratory failure or shock.

Intervention: Patients will be randomized to groups receiving usual care, physical rehabilitation, or cognitive rehabilitation plus physical rehabilitation. Twice-daily cognitive rehabilitation sessions will be performed with patients who are noncomatose and will consist of orientation, memory, and attention exercises (eg, forward and reverse digit spans, matrix puzzles, letter-number sequences, pattern recognition). Daily physical rehabilitation sessions will advance patients from passive range of motion exercises through ambulation. Patients with cognitive or physical impairment at discharge will undergo a 12-week, in-home cognitive rehabilitation program.

Measurements: A battery of neurocognitive and functional outcomes will be measured 3 and 12 months after hospital discharge.

Conclusions: If feasible, these interventions will lay the groundwork for a larger, multicenter trial to determine their efficacy.

Trial registration: ClinicalTrials.gov NCT01270269.

Figure 1.

Flow diagram of the Activity and Cognitive Therapy in the ICU (ACT-ICU) Trial. Patients will be screened for pre-existing cognitive or physical impairments and then randomized to 1 of 3 groups. Group 1 will receive usual care, group 2 will undergo treatment with a physical rehabilitation/early mobility protocol, and group 3 will undergo treatment with a paired cognitive and physical rehabilitation/early mobility protocol. If patients in group 3 demonstrate evidence of cognitive or physical impairments at hospital discharge, they will undergo a 12-week in-home cognitive rehabilitation program (goal management training [GMT]). Short-term and long-term outcomes will be assessed at 3 and 12 months following hospital discharge. Each day, all mechanically ventilated patients will be managed with a protocol of paired spontaneous awakening and breathing trials. Tower Test=Delis-Kaplan Executive Function System (D-KEFS) Tower Test, TUG=Timed “Up & Go” Test, MMSE=Mini-Mental State Examination, ADL=activities of daily living, IADL=instrumental activities of daily living.

Figure 2.

Inpatient early cognitive rehabilitation protocol. Sessions will be provided twice daily throughout the hospitalization. Prior to starting the session, the patient's level of consciousness will be determined using the Richmond Agitation-Sedation Scale (RASS). A patient who is only arousable to physical stimuli (RASS −5/−4) will not receive any intervention. Once a patient is able to open his or her eyes to voice (RASS −3/−2), study personnel will perform an orientation exercise. Once a patient is awake and alert, he or she will work through a series of exercises beginning with orientation exercise and progressing through a series of progressively more difficult exercises of attention and memory. Finally, each patient will be provided with games and puzzles to work on independent of study personnel. ICU=intensive care unit.

Figure 3.

Physical rehabilitation protocol. Patient's level of consciousness using the Richmond Agitation-Sedation Scale (RASS) will be determined prior to the daily physical rehabilitation session. A patient who is only arousable to physical stimuli (RASS −5/−4) will undergo passive range of motion (ROM) exercises. Once a patient is able to open his or her eyes to voice (RASS −2/−3), passive ROM exercises will be performed, and the patient will be placed in the chair position in bed. Finally, once a patient is alert and calm, he or she will progress from active ROM up through ambulation as he or she is able. Sessions will continue until hospital discharge or a patient meets certain functional milestones. ICU=intensive care unit, ADL=activities of daily living. Figure modified from Morris et al.