Clinical trial NCT01270269: ACT-ICU Study: Activity and Cognitive Therapy in the Intensive Care Unit
Official title: ACT-ICU Study: Activity and Cognitive Therapy in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Dementia
Myopathies
Muscle Disorders
Keywords: Asthenia
Muscle Weakness
Brain Injuries
Critical Illness
Critical Illness Myoneuropathy
Rehabilitation
Sepsis
Respiratory Failure
Delirium
Over-sedation
Immobility
Aging
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Disorders of Environmental Origin
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
First posted: 2011-01-05
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intensive care unit (ICU) hospitalization saves lives but often does so at a high personal cost to ICU survivors who frequently experience significant cognitive impairment and an array of physical and functional disabilities that limit their recovery and quality of life. While the problems experienced by these patients are likely amenable to rehabilitation, few ICU survivors receive focused rehabilitation. Recently, early physical rehabilitation in ICU patients has shown to improve the chances a patient will regain their pre-hospital functional status. Early cognitive rehabilitation for these patients has not yet been explored. This pilot study will determine the feasibility of early cognitive rehabilitation in ICU patients. The investigators will perform cognitive and physical rehabilitation, beginning in the earliest phases of critical illness, to determine the effect of these therapies on cognitive and functional outcomes in ICU survivors. The investigators hypothesize that combined cognitive and physical rehabilitation, started in the ICU, will improve recovery of cognitive and physical function as well as improve quality of life of ICU survivors.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Tower Test
timeFrame: 3 months post hospital discharge
Secondary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: 3 months post hospital discharge
measure: Functional Activities Questionnaire
timeFrame: 3 months post hospital discharge
measure: EQ-5 Global Scores
timeFrame: 3 months post hospital discharge
measure: Katz Activities of Daily Living (ADL) scale
timeFrame: 3 months post hospital discharge
measure: Activities-Specific Balance Confidence Scale (ABC)
timeFrame: 3 months post hospital discharge
measure: AD8
timeFrame: 3 months post hospital discharge
measure: Short-Informant Questionnaire of Cognitive Decline in the Elderly (Short IQCODE)
timeFrame: 3 months post hospital discharge
measure: Mini Mental State Exam (MMSE)
timeFrame: 3 months post hospital discharge
measure: Dysexecutive Questionnaire (Dys Exec)
timeFrame: 3 months post hospital discharge
measure: TRAILS A & B Test
timeFrame: 3 months post hospital discharge
measure: General and Employment Questionnaire
timeFrame: 3 months post hospital discharge
measure: Canadian Study of Health and Aging (CHSA) Frailty Scale
timeFrame: 3 months post hospital discharge
measure: Tower Test
timeFrame: 12 months post hospital discharge
measure: Timed Up and Go (TUG)
timeFrame: 12 months post hospital discharge
measure: Functional Activities Questionnaire
timeFrame: 12 months post-hospital discharge
measure: EQ-5 Global Scores
timeFrame: 12 months post hospital discharge
measure: Katz Activities of Daily Living (ADL) scale
timeFrame: 12 months post hospital discharge
measure: Activities-Specific Balance Confidence Scale (ABC)
timeFrame: 12 months post hospital discharge
measure: AD8
timeFrame: 12 months post hospital discharge
measure: Short-Informant Questionnaire of Cognitive Decline in the Elderly (Short IQCODE)
timeFrame: 12 months post hospital discharge
measure: Mini Mental State Exam (MMSE)
timeFrame: 12 months post hospital discharge
measure: Dysexecutive Questionnaire (Dys Exec)
timeFrame: 12 months post hospital discharge
measure: TRAILS A & B Test
timeFrame: 12 months post hospital discharge
measure: General and Employment Questionnaire
timeFrame: 12 months post hospital discharge
measure: Canadian Study of Health and Aging (CHSA) Frailty Scale
timeFrame: 12 months post hospital discharge
measure: Mortality
timeFrame: 2 months post hospital discharge
measure: Rehospitalization rate and number of hospital days
timeFrame: 12 months post hospital discharge
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Medicine
name: Nathan E. Brummel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schweickert WD, Herlitz J, Pohlman AS, Gehlbach BK, Hall JB, Kress JP. A randomized, controlled trial evaluating postinsertion neck ultrasound in peripherally inserted central catheter procedures. Crit Care Med. 2009 Apr;37(4):1217-21. doi: 10.1097/CCM.0b013e31819cee7f.
citation: Brummel NE, Jackson JC, Girard TD, Pandharipande PP, Schiro E, Work B, Pun BT, Boehm L, Gill TM, Ely EW. 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. Phys Ther. 2012 Dec;92(12):1580-92. doi: 10.2522/ptj.20110414. Epub 2012 May 10.
citation: Jackson JC, Ely EW, Morey MC, Anderson VM, Denne LB, Clune J, Siebert CS, Archer KR, Torres R, Janz D, Schiro E, Jones J, Shintani AK, Levine B, Pun BT, Thompson J, Brummel NE, Hoenig H. Cognitive and physical rehabilitation of intensive care unit survivors: results of the RETURN randomized controlled pilot investigation. Crit Care Med. 2012 Apr;40(4):1088-97. doi: 10.1097/CCM.0b013e3182373115.
citation: Brummel NE, Girard TD, Ely EW, Pandharipande PP, Morandi A, Hughes CG, Graves AJ, Shintani A, Murphy E, Work B, Pun BT, Boehm L, Gill TM, Dittus RS, Jackson JC. Feasibility and safety of early combined cognitive and physical therapy for critically ill medical and surgical patients: the Activity and Cognitive Therapy in ICU (ACT-ICU) trial. Intensive Care Med. 2014 Mar;40(3):370-9. doi: 10.1007/s00134-013-3136-0. Epub 2013 Nov 21.