Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): Study protocol for a randomized controlled trial

Sophia Wang, Jessica Hammes, Sikandar Khan, Sujuan Gao, Amanda Harrawood, Stephanie Martinez, Lyndsi Moser, Anthony Perkins, Frederick Unverzagt, Daniel Clark, Malaz Boustani, Babar Khan

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: Delirium affects nearly 70% of older adults hospitalized in the intensive care unit (ICU), and many of those will be left with persistent cognitive impairment or dementia. There are no effective and scalable recovery models to remediate ICU-acquired cognitive impairment and its attendant elevated risk for dementia or Alzheimer disease (AD). The Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) trial is an ongoing clinical trial which evaluates the efficacy of a combined physical exercise and cognitive training on cognitive function among ICU survivors 50 years and older who experienced delirium during an ICU stay. This article describes the study protocol for IMPROVE. Methods: IMPROVE is a four-arm, randomized controlled trial. Subjects will be randomized to one of four arms: cognitive training and physical exercise; cognitive control and physical exercise; cognitive training and physical exercise control; and cognitive control and physical exercise control. Facilitators administer the physical exercise and exercise control interventions in individual and small group formats by using Internet-enabled videoconference. Cognitive training and control interventions are also facilitator led using Posit Science, Inc. online modules delivered in individual and small group format directly into the participants' homes. Subjects complete cognitive assessment, mood questionnaires, physical performance batteries, and quality of life scales at baseline, 3, and 6 months. Blood samples will also be taken at baseline and 3 months to measure pro-inflammatory cytokines and acute-phase reactants; neurotrophic factors; and markers of glial dysfunction and astrocyte activation. Discussion: This study is the first clinical trial to examine the efficacy of combined physical and cognitive exercise on cognitive function in older ICU survivors with delirium. The results will provide information about potential synergistic effects of a combined intervention on a range of outcomes and mechanisms of action.

Original languageEnglish (US)
Article number196
JournalTrials
Volume19
Issue number1
DOIs
StatePublished - Mar 27 2018

Fingerprint

Intensive Care Units
Randomized Controlled Trials
Exercise
Delirium
Cognition
Survivors
Dementia
Clinical Trials
Videoconferencing
Acute-Phase Proteins
Nerve Growth Factors
Neuroglia
Astrocytes
Internet
Alzheimer Disease
Quality of Life
Cytokines

Keywords

  • Aging
  • Alzheimer disease
  • Biomarkers
  • Cognitive impairment
  • Cognitive training
  • Critical care
  • Delirium
  • Dementia
  • Internet delivery
  • Physical activity
  • Physical exercise
  • Post-intensive care syndrome

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) : Study protocol for a randomized controlled trial. / Wang, Sophia; Hammes, Jessica; Khan, Sikandar; Gao, Sujuan; Harrawood, Amanda; Martinez, Stephanie; Moser, Lyndsi; Perkins, Anthony; Unverzagt, Frederick; Clark, Daniel; Boustani, Malaz; Khan, Babar.

In: Trials, Vol. 19, No. 1, 196, 27.03.2018.

Research output: Contribution to journalArticle

Wang, Sophia ; Hammes, Jessica ; Khan, Sikandar ; Gao, Sujuan ; Harrawood, Amanda ; Martinez, Stephanie ; Moser, Lyndsi ; Perkins, Anthony ; Unverzagt, Frederick ; Clark, Daniel ; Boustani, Malaz ; Khan, Babar. / Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) : Study protocol for a randomized controlled trial. In: Trials. 2018 ; Vol. 19, No. 1.
@article{53e40b99a7a74343987bc1362a2861ec,
title = "Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): Study protocol for a randomized controlled trial",
abstract = "Background: Delirium affects nearly 70{\%} of older adults hospitalized in the intensive care unit (ICU), and many of those will be left with persistent cognitive impairment or dementia. There are no effective and scalable recovery models to remediate ICU-acquired cognitive impairment and its attendant elevated risk for dementia or Alzheimer disease (AD). The Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) trial is an ongoing clinical trial which evaluates the efficacy of a combined physical exercise and cognitive training on cognitive function among ICU survivors 50 years and older who experienced delirium during an ICU stay. This article describes the study protocol for IMPROVE. Methods: IMPROVE is a four-arm, randomized controlled trial. Subjects will be randomized to one of four arms: cognitive training and physical exercise; cognitive control and physical exercise; cognitive training and physical exercise control; and cognitive control and physical exercise control. Facilitators administer the physical exercise and exercise control interventions in individual and small group formats by using Internet-enabled videoconference. Cognitive training and control interventions are also facilitator led using Posit Science, Inc. online modules delivered in individual and small group format directly into the participants' homes. Subjects complete cognitive assessment, mood questionnaires, physical performance batteries, and quality of life scales at baseline, 3, and 6 months. Blood samples will also be taken at baseline and 3 months to measure pro-inflammatory cytokines and acute-phase reactants; neurotrophic factors; and markers of glial dysfunction and astrocyte activation. Discussion: This study is the first clinical trial to examine the efficacy of combined physical and cognitive exercise on cognitive function in older ICU survivors with delirium. The results will provide information about potential synergistic effects of a combined intervention on a range of outcomes and mechanisms of action.",
keywords = "Aging, Alzheimer disease, Biomarkers, Cognitive impairment, Cognitive training, Critical care, Delirium, Dementia, Internet delivery, Physical activity, Physical exercise, Post-intensive care syndrome",
author = "Sophia Wang and Jessica Hammes and Sikandar Khan and Sujuan Gao and Amanda Harrawood and Stephanie Martinez and Lyndsi Moser and Anthony Perkins and Frederick Unverzagt and Daniel Clark and Malaz Boustani and Babar Khan",
year = "2018",
month = "3",
day = "27",
doi = "10.1186/s13063-018-2569-8",
language = "English (US)",
volume = "19",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Improving Recovery and Outcomes Every Day after the ICU (IMPROVE)

T2 - Study protocol for a randomized controlled trial

AU - Wang, Sophia

AU - Hammes, Jessica

AU - Khan, Sikandar

AU - Gao, Sujuan

AU - Harrawood, Amanda

AU - Martinez, Stephanie

AU - Moser, Lyndsi

AU - Perkins, Anthony

AU - Unverzagt, Frederick

AU - Clark, Daniel

AU - Boustani, Malaz

AU - Khan, Babar

PY - 2018/3/27

Y1 - 2018/3/27

N2 - Background: Delirium affects nearly 70% of older adults hospitalized in the intensive care unit (ICU), and many of those will be left with persistent cognitive impairment or dementia. There are no effective and scalable recovery models to remediate ICU-acquired cognitive impairment and its attendant elevated risk for dementia or Alzheimer disease (AD). The Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) trial is an ongoing clinical trial which evaluates the efficacy of a combined physical exercise and cognitive training on cognitive function among ICU survivors 50 years and older who experienced delirium during an ICU stay. This article describes the study protocol for IMPROVE. Methods: IMPROVE is a four-arm, randomized controlled trial. Subjects will be randomized to one of four arms: cognitive training and physical exercise; cognitive control and physical exercise; cognitive training and physical exercise control; and cognitive control and physical exercise control. Facilitators administer the physical exercise and exercise control interventions in individual and small group formats by using Internet-enabled videoconference. Cognitive training and control interventions are also facilitator led using Posit Science, Inc. online modules delivered in individual and small group format directly into the participants' homes. Subjects complete cognitive assessment, mood questionnaires, physical performance batteries, and quality of life scales at baseline, 3, and 6 months. Blood samples will also be taken at baseline and 3 months to measure pro-inflammatory cytokines and acute-phase reactants; neurotrophic factors; and markers of glial dysfunction and astrocyte activation. Discussion: This study is the first clinical trial to examine the efficacy of combined physical and cognitive exercise on cognitive function in older ICU survivors with delirium. The results will provide information about potential synergistic effects of a combined intervention on a range of outcomes and mechanisms of action.

AB - Background: Delirium affects nearly 70% of older adults hospitalized in the intensive care unit (ICU), and many of those will be left with persistent cognitive impairment or dementia. There are no effective and scalable recovery models to remediate ICU-acquired cognitive impairment and its attendant elevated risk for dementia or Alzheimer disease (AD). The Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) trial is an ongoing clinical trial which evaluates the efficacy of a combined physical exercise and cognitive training on cognitive function among ICU survivors 50 years and older who experienced delirium during an ICU stay. This article describes the study protocol for IMPROVE. Methods: IMPROVE is a four-arm, randomized controlled trial. Subjects will be randomized to one of four arms: cognitive training and physical exercise; cognitive control and physical exercise; cognitive training and physical exercise control; and cognitive control and physical exercise control. Facilitators administer the physical exercise and exercise control interventions in individual and small group formats by using Internet-enabled videoconference. Cognitive training and control interventions are also facilitator led using Posit Science, Inc. online modules delivered in individual and small group format directly into the participants' homes. Subjects complete cognitive assessment, mood questionnaires, physical performance batteries, and quality of life scales at baseline, 3, and 6 months. Blood samples will also be taken at baseline and 3 months to measure pro-inflammatory cytokines and acute-phase reactants; neurotrophic factors; and markers of glial dysfunction and astrocyte activation. Discussion: This study is the first clinical trial to examine the efficacy of combined physical and cognitive exercise on cognitive function in older ICU survivors with delirium. The results will provide information about potential synergistic effects of a combined intervention on a range of outcomes and mechanisms of action.

KW - Aging

KW - Alzheimer disease

KW - Biomarkers

KW - Cognitive impairment

KW - Cognitive training

KW - Critical care

KW - Delirium

KW - Dementia

KW - Internet delivery

KW - Physical activity

KW - Physical exercise

KW - Post-intensive care syndrome

UR - http://www.scopus.com/inward/record.url?scp=85045284430&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85045284430&partnerID=8YFLogxK

U2 - 10.1186/s13063-018-2569-8

DO - 10.1186/s13063-018-2569-8

M3 - Article

C2 - 29580264

AN - SCOPUS:85045284430

VL - 19

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 196

ER -