ACT-ICU Study: Activity and Cognitive Therapy in the Intensive Care Unit
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| City: |
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Nashville |
| State: |
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Tennessee |
| Zip Code: |
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37232 |
| Conditions: |
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Brain Injuries - Dementia - Myopathies - Muscle Disorders |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01270269 |
| Primary Contact: |
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Principal Investigator
Nathan E. Brummel, MD
Vanderbilt University School of Medicine
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| Backup Contact: |
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N/A |
| Location Contact: |
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Nashville, Tennessee 37232
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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