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Trial record 3 of 3424 for:    Indiana Health

Improving the Recovery and Outcome Every Day After the ICU (IMPROVE)

This study is currently recruiting participants.
Verified October 2017 by Babar Khan, MD, MS, Indiana University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03095417
First Posted: March 29, 2017
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Babar Khan, MD, MS, Indiana University
  Purpose

Primary Specific Aim: Determine the effect of the combined physical exercise and cognitive training on the cognitive function of ICU survivors aged 65 and older. Hypothesis: In comparison to older ICU survivors randomized to attention control or either intervention alone, those randomized to 12 weeks of combined physical exercise and cognitive training will have higher total index cognitive scores as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at 3 and 6 months post randomization.

Secondary Specific Aim 1: Determine the effect of the combined physical exercise and cognitive training on physical performance, anxiety and depressive symptoms, and quality of life of ICU survivors aged 65 and older. Hypotheses: In comparison to older ICU survivors randomized to attention control or either intervention alone, those randomized to 12 weeks of combined physical exercise and cognitive training will have higher physical performance as measured by short physical performance battery (SPPB) and two-minute step test, lower mood and anxiety symptoms as measured by Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) scale, and higher quality of life as measured by the Medical Outcomes Study 36-item short form (SF-36) at 3 and 6-months post randomization.

Secondary Specific Aim 2: To examine the mechanisms of action of combined training. Hypothesis: At the completion of treatment, the combined intervention group will show reduced serum levels of CRP, IL-1, IL-6, IL-8, TNF-α, S-100β, and GFAP and increased levels of BDNF, VEGF, and IGF-1 compared to the attention control, or either intervention alone groups.


Condition Intervention
Delirium Alzheimer Disease Behavioral: Physical Exercise Intervention Behavioral: Cognitive Training Intervention Behavioral: Stretching Control Behavioral: Cognitive Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Decreasing Alzheimer's Disease and Related Dementias After Delirium- Exercise and Cognitive Training

Resource links provided by NLM:


Further study details as provided by Babar Khan, MD, MS, Indiana University:

Primary Outcome Measures:
  • Cognitive Status Outcome at 6 months [ Time Frame: 6 months post study randomization ]
    The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be used to measure cognitive status.

  • Cognitive Status Outcome at 3 months [ Time Frame: 3 months post study randomization ]
    The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be used to measure cognitive status.


Secondary Outcome Measures:
  • Quality of Life Scores at 3 months [ Time Frame: 3 month post study randomization ]
    The Medical Outcomes Study 36 item short form (SF-36) will measure participant quality of life scores.

  • Quality of Life Scores at 6 months [ Time Frame: 6 month post study randomization ]
    The Medical Outcomes Study 36 item short form (SF-36) will measure participant quality of life scores.


Estimated Enrollment: 344
Actual Study Start Date: September 25, 2017
Estimated Study Completion Date: June 1, 2023
Estimated Primary Completion Date: June 1, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical Exercise and Cognitive Training

Physical Exercise Intervention: The physical exercise portion of the combined intervention consists of 45 minutes of multi-modal physical exercise focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength and endurance consistent with current exercise recommendations. The study team will deliver 3 sessions per week for 3 months.

Cognitive Intervention: The cognitive portion of the combined intervention consists of a suite of 24 programs called Brain HQ developed by Posit Science Inc., organized into six categories: attention, speed, memory, people skills, intelligence, and navigation. The DDD-ECT trial will use 45-minute sessions of Brain HQ exercises. The modules are designed to improve time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory.

Behavioral: Physical Exercise Intervention
In home exercise intervention.
Behavioral: Cognitive Training Intervention
Online cognitive training modules.
Other Name: Brain HQ
Active Comparator: Physical Exercise and Cognitive Control

Physical Exercise Intervention: The physical exercise portion of the combined intervention consists of 45 minutes of multi-modal physical exercise focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength and endurance consistent with current exercise recommendations. The study team will deliver 3 sessions per week for 3 months.

Cognitive Control: This consists of 45 minutes of educational arts programing and puzzles, 2 days per week for 3 months. The participants will use on-line puzzles and games via the Thinks.com website which has been used in a cognitive training RCT as an attention control and found to not result in cognitive benefit.

Behavioral: Physical Exercise Intervention
In home exercise intervention.
Behavioral: Cognitive Control
Online puzzles and games.
Other Name: Thinks.com
Active Comparator: Cognitive Training and Stretching Control

Stretching Control: This consists of 45 minutes of stretching and discussion of successful aging. The study team will deliver 3 sessions per week for 3 months.

Cognitive Intervention: The cognitive portion of the combined intervention consists of a suite of 24 programs called Brain HQ developed by Posit Science Inc., organized into six categories: attention, speed, memory, people skills, intelligence, and navigation. The DDD-ECT trial will use 45-minute sessions of Brain HQ exercises. The modules are designed to improve time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. ly directing one session per week and available as needed for rest of the sessions.

Behavioral: Cognitive Training Intervention
Online cognitive training modules.
Other Name: Brain HQ
Behavioral: Stretching Control
In home stretching and healthy aging discussion.
Active Comparator: Cognitive Control and Stretching Control

Stretching Control: This consists of 45 minutes of stretching and discussion of successful aging. The study team will deliver 3 sessions per week for 3 months.

Cognitive Control: This consists of 45 minutes of educational arts programing and puzzles, 2 days per week for 3 months. The participants will use on-line puzzles and games via the Thinks.com website which has been used in a cognitive training RCT as an attention control and found to not result in cognitive benefit.

Behavioral: Stretching Control
In home stretching and healthy aging discussion.
Behavioral: Cognitive Control
Online puzzles and games.
Other Name: Thinks.com

Detailed Description:

Critical illness has deleterious consequences on both acute and chronic cognitive functions. Acute cognitive dysfunction manifests itself as delirium in the critically ill especially the elderly. Delirium is a complex neuropsychiatric syndrome characterized by acute and fluctuating changes in cognition and consciousness. 60% to 80% of critically ill ventilated older patients and 30% to 50% of those with less illness severity have delirium for at least one day of their ICU or hospital stay. Chronic cognitive dysfunction manifests as ICU acquired cognitive impairment and dementia after critical illness, affects multiple cognitive domains and persists years after hospital discharge. Up to 71% of critical illness survivors have cognitive impairment at one year after hospital discharge and close to 18% are diagnosed with new dementia including Alzheimer's disease within three years post ICU hospitalization.

Two million older Americans suffer from an episode of delirium during their intensive care unit (ICU) stay. Presence of delirium predisposes the elderly to immediate in-hospital complications including a longer length of ICU and hospital stay, increased risk of in-patient mortality and elevated costs of care. In addition, ICU delirium is associated with long-term post-discharge complications such as development of cognitive impairment and dementia. Current advances in the management of critical illness have notably improved the survival rates among this vulnerable segment of older adults. However, increased survival comes at a cost with as many as 70% of older ICU survivors who had an episode of delirium suffering from subsequent cognitive impairment and dementia. At present, there are no effective and scalable recovery models to remediate ICU acquired cognitive impairment and its attendant elevated dementia or Alzheimer's disease risk.

The inability to develop efficacious interventions to reduce ICU acquired cognitive impairment may stem from a limited understanding of the link between acute brain dysfunction (delirium) and chronic brain dysfunction (ICU acquired cognitive impairment, dementia or Alzheimer's disease). The investigators propose a recovery intervention guided by the pathophysiologic mechanisms implicated in producing critical illness delirium and elevated risk of cognitive impairment. The intervention targets inflammation, glial dysfunction and astrocyte activation along with restoration of neurotrophic factors while training function directly across multiple cognitive domains to reduce the burden of cognitive impairment among ICU survivors of delirium.

Over the past five years, Indiana University Center for Aging Research has developed a research infrastructure focused on delirium and delirium associated cognitive impairment, encompassing the ICU and post-ICU periods. This includes developing a bio-repository of serum delirium biomarkers, ICU based delirium trials, and post-ICU exercise and cognitive therapy recovery models. Building upon prior work and based on the pathophysiologic mechanisms mentioned above, the investigators now propose a novel home-based combined physical exercise and cognitive training program for older ICU survivors to improve cognitive impairment.

The study team is proposing a 2x2 factorial design randomized controlled trial (RCT) called "Decreasing Alzheimer's Disease and Related Dementias after Delirium-Exercise and Cognitive Training (DDD-ECT)" to evaluate the efficacy of 12 weeks of combined physical exercise and cognitive training on the primary outcome of cognitive function among older ICU survivors who experienced delirium during their ICU stay. The investigators propose to deliver these interventions via a facilitator-led, small group format using internet-enabled, multiparty-videoconference delivered directly into the participants' homes to achieve the study aims listed in the summary.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged ≥ 65 years
  • Admitted to medical and/or surgical ICUs at Methodist, University, or Eskenazi hospitals
  • Discharged home
  • Able to provide consent or has a legally authorized representative to provide consent
  • Access to a telephone (study provides computer and broadband)
  • Have at least one episode of delirium as determined by the Confusion Assessment Method for the ICU.

Exclusion Criteria:

  • Self-reported diagnosis of cancer with short life expectancy
  • Current chemotherapy or radiation therapy (confirmed by electronic medical record)
  • History of dementing illnesses and other neurodegenerative disease such as Alzheimer's disease, Parkinson disease, or vascular dementia (confirmed by EMR)
  • Current alcohol consumption > 5 drinks per day (self reported and/or confirmed by EMR)
  • Vision < 20/80 via Snellen card
  • Low hearing or communicative ability (examiner rated) that would interfere with interventions and outcome assessments
  • Have delirium at time of hospital discharge (confirmed by EMR and/or study team evaluated)
  • Have any American College of Sports Medicine absolute contraindications to exercise including: acute myocardial infarctions within the past 2 days, ongoing unstable angina, uncontrolled cardiac arrhythmia with hemodynamic compromise, active endocarditis, symptomatic severe aortic stenosis, decompensated heart failure, acute pulmonary embolism, pulmonary infarction, or deep venous thrombosis, acute myocarditis or pericarditis, acute aortic dissection, physical disability that precludes safe and adequate testing, or are unable to obtain provider clearance for physical exercise (confirmed by EMR)
  • Have any American College of Sports Medicine relative contraindications to exercise including: known obstructive left main coronary stenosis, moderate to severe aortic stenosis with uncertain relationship to symptoms, tachydysrhythmias with uncontrolled ventricular rates, acquired advanced or complete heart block, recent stroke or transient ischemia attack, mental impairment with limited ability to cooperate, resting hypertension with systolic >200 mm Hg or diastolic >100 mm Hg, uncorrected medical conditions, such as significant anemia, important electrolyte imbalance, and hyperthyroidism, or are unable to obtain provider clearance for physical exercise (confirmed by EMR)
  • Recovering from a skeletal fracture (confirmed by EMR)
  • Stroke as the admitting diagnosis or a new event during the course of hospitalization (confirmed by EMR)
  • Recent history of drug abuse [Drug abuse and screening test (DAST-20) score>5].
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095417


Contacts
Contact: Amanda M Harrawood, BS 317-274-9099 aharrawo@iupui.edu

Locations
United States, Indiana
Eskenazi Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Babar Khan, MD         
Indiana Health University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Babar Khan         
Indiana University Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Babar Khan, MD         
Sponsors and Collaborators
Indiana University
  More Information

Responsible Party: Babar Khan, MD, MS, Assistant Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT03095417     History of Changes
Other Study ID Numbers: 1608126693
First Submitted: March 23, 2017
First Posted: March 29, 2017
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Babar Khan, MD, MS, Indiana University:
Delirium
Alzheimer's Disease
Aging
Exercise Therapy
Cognitive Training

Additional relevant MeSH terms:
Alzheimer Disease
Delirium
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms