Overview

This trial is active, not recruiting.

Conditions brain injuries, dementia, myopathies, muscle disorders
Treatments behavioral: physical and functional rehabilitation, behavioral: cognitive, physical, & functional rehabilitation
Phase phase 1
Sponsor Vanderbilt University
Start date February 2011
End date March 2013
Trial size 90 participants
Trial identifier NCT01270269, 101037

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(No Intervention)
Patients (Controls) will not receive formal (study-related) rehabilitation interventions and will only receive usual care.
(Experimental)
A multi-component program of physical rehabilitation interventions (without cognitive rehabilitation) will be delivered to patients beginning in the ICU and continue throughout the hospitalization.
behavioral: physical and functional rehabilitation cognitive rehabilitation
A multi-component program of physical rehabilitation interventions (without cognitive rehabilitation) will be delivered to patients beginning in the ICU and continue throughout the hospitalization.
(Experimental)
A multi-component program of cognitive, physical, and functional rehabilitation interventions will be delivered to patients beginning in the ICU with continued cognitive rehabilitation in their home environments over a focused 12-week period.
behavioral: cognitive, physical, & functional rehabilitation cognitive rehabilitation
A multi-component program of cognitive, physical, and functional rehabilitation interventions will be delivered to patients beginning in the ICU with continued cognitive rehabilitation in their home environments over a focused 12-week period.

Primary Outcomes

Measure
Tower Test
time frame: 3 months post hospital discharge

Secondary Outcomes

Measure
Timed Up and Go (TUG)
time frame: 3 months post hospital discharge
Functional Activities Questionnaire
time frame: 3 months post hospital discharge
EQ-5 Global Scores
time frame: 3 months post hospital discharge
Katz Activities of Daily Living (ADL) scale
time frame: 3 months post hospital discharge
Activities-Specific Balance Confidence Scale (ABC)
time frame: 3 months post hospital discharge
AD8
time frame: 3 months post hospital discharge
Short-Informant Questionnaire of Cognitive Decline in the Elderly (Short IQCODE)
time frame: 3 months post hospital discharge
Mini Mental State Exam (MMSE)
time frame: 3 months post hospital discharge
Dysexecutive Questionnaire (Dys Exec)
time frame: 3 months post hospital discharge
TRAILS A & B Test
time frame: 3 months post hospital discharge
General and Employment Questionnaire
time frame: 3 months post hospital discharge
Canadian Study of Health and Aging (CHSA) Frailty Scale
time frame: 3 months post hospital discharge
Tower Test
time frame: 12 months post hospital discharge
Timed Up and Go (TUG)
time frame: 12 months post hospital discharge
Functional Activities Questionnaire
time frame: 12 months post-hospital discharge
EQ-5 Global Scores
time frame: 12 months post hospital discharge
Katz Activities of Daily Living (ADL) scale
time frame: 12 months post hospital discharge
Activities-Specific Balance Confidence Scale (ABC)
time frame: 12 months post hospital discharge
AD8
time frame: 12 months post hospital discharge
Short-Informant Questionnaire of Cognitive Decline in the Elderly (Short IQCODE)
time frame: 12 months post hospital discharge
Mini Mental State Exam (MMSE)
time frame: 12 months post hospital discharge
Dysexecutive Questionnaire (Dys Exec)
time frame: 12 months post hospital discharge
TRAILS A & B Test
time frame: 12 months post hospital discharge
General and Employment Questionnaire
time frame: 12 months post hospital discharge
Canadian Study of Health and Aging (CHSA) Frailty Scale
time frame: 12 months post hospital discharge
Mortality
time frame: 2 months post hospital discharge
Rehospitalization rate and number of hospital days
time frame: 12 months post hospital discharge

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title ACT-ICU Study: Activity and Cognitive Therapy in the Intensive Care Unit
Principal investigator Nathan E. Brummel, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Vanderbilt University.