Brain InjuriesACT-ICUNCT01270269
ACT-ICU Study: Activity and Cognitive Therapy in the Intensive Care Unit
A study testing Behavioral: Physical and functional rehabilitation and Behavioral: Cognitive, physical, & functional rehabilitation in people with Brain Injuries and Dementia, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Dementia, Myopathies
- What is being tested?
- Behavioral: Physical and functional rehabilitation and Behavioral: Cognitive, physical, & functional rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients admitted to the medical or surgical ICU who are receiving treatment for respiratory failure, cardiogenic shock, hemorrhagic shock, and/or septic shock.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
Read the 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.
- Conditions
- Brain Injuries, Dementia, Myopathies, Muscle Disorders
- Being tested
- Behavioral: Physical and functional rehabilitation, Behavioral: Cognitive, physical, & functional rehabilitation
- 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
- Medical subject headings
- Brain Injuries, Dementia, Muscular Diseases, Asthenia, Muscle Weakness, Critical Illness, Sepsis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Physical and functional rehabilitationBehavioural
Also called 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.
Behavioral: Cognitive, physical, & functional rehabilitationBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients (Controls) | No intervention | Patients (Controls) will not receive formal (study-related) rehabilitation interventions and will only receive usual care. |
| Behavioral: Phys & Func Rehab | 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. Receives: Behavioral: Behavioral: Physical and functional rehabilitation |
| Behavioral: Cog/Phys/Func Rehab | 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. Receives: Behavioral: Behavioral: Cognitive, physical, & functional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tower Test
A psychometric measure of executive functioning.
Measured: 3 months post hospital discharge
Secondary outcomes (27)
Timed Up and Go (TUG)
A timed test assessing physical strength and gait speed.
Measured: 3 months post hospital discharge
Functional Activities Questionnaire
A brief measure of higher order (IADL) functioning.
Measured: 3 months post hospital discharge
EQ-5 Global Scores
The EQ-5 Global Scores is an assessment of quality of life.
Measured: 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.
Measured: 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.
Measured: 3 months post hospital discharge
AD8
A brief surrogate or patient based measure that assesses recent change in a variety of cognitive abilities.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 3 months post hospital discharge
Tower Test
A psychometric measure of executive functioning.
Measured: 12 months post hospital discharge
Timed Up and Go (TUG)
A timed test assessing physical strength and gait speed.
Measured: 12 months post hospital discharge
Functional Activities Questionnaire
A brief measure of higher order (IADL) functioning.
Measured: 12 months post-hospital discharge
EQ-5 Global Scores
The EQ-5 Global Scores is an assessment of quality of life.
Measured: 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.
Measured: 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.
Measured: 12 months post hospital discharge
AD8
A brief surrogate or patient based measure that assesses recent change in a variety of cognitive abilities.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 12 months post hospital discharge
Mortality
Measured: 2 months post hospital discharge
Rehospitalization rate and number of hospital days
Measured: 12 months post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Responsible party
- Principal investigator, Nathan Brummel, Vanderbilt University
- Investigators
- Nathan E. Brummel, MD, Principal investigator, Vanderbilt University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270269
- Sponsor's protocol ID
- 101037
- Acronym
- ACT-ICU
- Status last verified
- Mar 2017
- First submitted
- 2 Nov 2010
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19242336Brummel 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.
PubMed 22577067Jackson 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.
PubMed 22080631Brummel 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.
PubMed 24257969
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACT-ICU Study: Activity and Cognitive Therapy in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01270269
- Acronym / sponsor ID
- ACT-ICU / 101037
- Conditions
- Brain Injuries, Dementia, Myopathies, Muscle Disorders
- Keywords
- Asthenia, Muscle Weakness, Brain Injuries, Critical Illness, Critical Illness Myoneuropathy, Rehabilitation, Sepsis, Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Study start
- Feb 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients (Controls) | No intervention | –Patients (Controls) will not receive formal (study-related) rehabilitation interventions and will only receive usual care. |
| Behavioral: Phys & Func Rehab | Experimental | Behavioral: Behavioral: Physical and functional rehabilitationA 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: Cog/Phys/Func Rehab | Experimental | Behavioral: Behavioral: Cognitive, physical, & functional rehabilitationA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients admitted to the medical or surgical ICU who are receiving treatment for respiratory failure, cardiogenic shock, hemorrhagic shock, and/or septic shock.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: Physical and functional rehabilitationAlso: cognitive rehabilitationA multi-component program of physical rehabilitation interventions (without cognitive rehabilitation) will be delivered to patients beginning in the ICU and continue throughout the hospitalization. | Behavioural | Behavioral: Phys & Func Rehab |
| Behavioral: Cognitive, physical, & functional rehabilitationAlso: cognitive rehabilitationA 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. | Behavioural | Behavioral: Cog/Phys/Func Rehab |
Primary outcome
Tower Test
Time frame: 3 months post hospital discharge
A psychometric measure of executive functioning.
27 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Background: PubMed 19242336Schweickert 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.
- Background: PubMed 22577067Brummel 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.
- Background: PubMed 22080631Jackson 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.
- Results publication: PubMed 24257969Brummel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan E. Brummel, MD principal investigator
Vanderbilt University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Physical and functional rehabilitation and Behavioral: Cognitive, physical, & functional rehabilitation in people with Brain Injuries and Dementia, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tower Test (time frame: 3 months post hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01270269, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.