An interventional study of Behavioral: Physical and functional rehabilitation and Behavioral: Cognitive, physical, & functional rehabilitation in Brain Injuries, Dementia and Myopathies, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Treatment
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.
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.
280 studies on the registry are indexed under Muscular Diseases; 63 are open to participants now.
This study's enrollment of 87 is above the median of 34 across 157 interventional studies indexed under Muscular Diseases.
Browse Muscular Diseases studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients (Controls) will not receive formal (study-related) rehabilitation interventions and will only receive usual care.
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: Behavioral: Physical and functional 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.
Behavioral: Behavioral: Cognitive, physical, & functional 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.
Also known as: 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.
Also known as: cognitive rehabilitation
Tower Test
A psychometric measure of executive functioning.
Time frame: 3 months post hospital discharge
Timed Up and Go (TUG)
A timed test assessing physical strength and gait speed.
Time frame: 3 months post hospital discharge
Functional Activities Questionnaire
A brief measure of higher order (IADL) functioning.
Time frame: 3 months post hospital discharge
EQ-5 Global Scores
The EQ-5 Global Scores is an assessment of quality of life.
Time frame: 3 months post hospital discharge
Katz Activities of Daily Living (ADL) scale
A six-item tool assessing the degree of independence vs. dependence in basic activities of daily living.
Time frame: 3 months post hospital discharge
Activities-Specific Balance Confidence Scale (ABC)
A brief rating scale that asks participants to rate how confident they are that they can maintain their balance and remain steady while engaged in 16 non-hazardous tasks.
Time frame: 3 months post hospital discharge
AD8
A brief surrogate or patient based measure that assesses recent change in a variety of cognitive abilities.
Time frame: 3 months post hospital discharge
Short-Informant Questionnaire of Cognitive Decline in the Elderly (Short IQCODE)
A measure of cognitive functioning that evaluates the degree of decline from baseline and which is complementary to the AD8. This measure will only be used in patients over the age of 50 who had any problems with memory or thinking prior to current illness.
Time frame: 3 months post hospital discharge
Mini Mental State Exam (MMSE)
A widely used measure of overall cognitive functioning that briefly samples abilities in a wide array of areas including memory and attention.
Time frame: 3 months post hospital discharge
Dysexecutive Questionnaire (Dys Exec)
A questionnaire, which has both patient and surrogate versions, that assesses patient functioning in a number of functional areas sensitive to executive dysfunction.
Time frame: 3 months post hospital discharge
TRAILS A & B Test
Two widely used to test the speed that it takes to connect a series of numbers (Part A) and numbers alternating with letters (Part B).
Time frame: 3 months post hospital discharge
General and Employment Questionnaire
A brief series of questions which pertain to patient history and demographics and which also inquire about employment both before and after ICU hospitalization.
Time frame: 3 months post hospital discharge
Canadian Study of Health and Aging (CHSA) Frailty Scale
A brief global rating scale of frailty based on clinical impression.
Time frame: 3 months post hospital discharge
Tower Test
A psychometric measure of executive functioning.
Time frame: 12 months post hospital discharge
Timed Up and Go (TUG)
A timed test assessing physical strength and gait speed.
Time frame: 12 months post hospital discharge
Functional Activities Questionnaire
A brief measure of higher order (IADL) functioning.
Time frame: 12 months post-hospital discharge
EQ-5 Global Scores
The EQ-5 Global Scores is an assessment of quality of life.
Time frame: 12 months post hospital discharge
Katz Activities of Daily Living (ADL) scale
A six-item tool assessing the degree of independence vs. dependence in basic activities of daily living.
Time frame: 12 months post hospital discharge
Activities-Specific Balance Confidence Scale (ABC)
A brief rating scale that asks participants to rate how confident they are that they can maintain their balance and remain steady while engaged in 16 non-hazardous tasks.
Time frame: 12 months post hospital discharge
AD8
A brief surrogate or patient based measure that assesses recent change in a variety of cognitive abilities.
Time frame: 12 months post hospital discharge
Short-Informant Questionnaire of Cognitive Decline in the Elderly (Short IQCODE)
A measure of cognitive functioning that evaluates the degree of decline from baseline and which is complementary to the AD8. This measure will only be used in patients over the age of 50 who had any problems with memory or thinking prior to current illness.
Time frame: 12 months post hospital discharge
Mini Mental State Exam (MMSE)
A widely used measure of overall cognitive functioning that briefly samples abilities in a wide array of areas including memory and attention.
Time frame: 12 months post hospital discharge
Dysexecutive Questionnaire (Dys Exec)
A questionnaire, which has both patient and surrogate versions, that assesses patient functioning in a number of functional areas sensitive to executive dysfunction.
Time frame: 12 months post hospital discharge
TRAILS A & B Test
Two widely used to test the speed that it takes to connect a series of numbers (Part A) and numbers alternating with letters (Part B).
Time frame: 12 months post hospital discharge
General and Employment Questionnaire
A brief series of questions which pertain to patient history and demographics and which also inquire about employment both before and after ICU hospitalization.
Time frame: 12 months post hospital discharge
Canadian Study of Health and Aging (CHSA) Frailty Scale
A brief global rating scale of frailty based on clinical impression.
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
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanderbilt University