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.

Trial registration

ClinicalTrials.gov, NCT03095417. Registered on 23 March 2017. Last updated on 15 May 2017.

Details

Title
Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial
Author
Wang, Sophia 1   VIAFID ORCID Logo  ; Hammes, Jessica 2 ; Khan, Sikandar 3 ; Gao, Sujuan 4 ; Harrawood, Amanda 5 ; Martinez, Stephanie 5 ; Moser, Lyndsi 6 ; Perkins, Anthony 7 ; Unverzagt, Frederick W. 6 ; Clark, Daniel O. 8 ; Boustani, Malaz 9 ; Khan, Babar 10 

1  Indiana University School of Medicine, Department of Psychiatry, Indianapolis, USA (GRID:grid.257413.6) (ISNI:0000 0001 2287 3919); Center for Translational Science and Innovation, Center of Health Innovation and Implementation Science, Indianapolis, USA (GRID:grid.257413.6); Eskenazi Hospital, Sandra Eskenazi Center for Brain Care Innovation, Indianapolis, USA (GRID:grid.257413.6) 
2  Indiana University Bloomington, College of Arts and Sciences, Bloomington, USA (GRID:grid.411377.7) (ISNI:0000 0001 0790 959X) 
3  Indiana University School of Medicine, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indianapolis, USA (GRID:grid.257413.6) (ISNI:0000 0001 2287 3919) 
4  Indiana University School of Medicine, Department of Biostatistics, Indianapolis, USA (GRID:grid.257413.6) (ISNI:0000 0001 2287 3919) 
5  Regenstrief Institute, IU Center of Aging Research, Indianapolis, USA (GRID:grid.448342.d) (ISNI:0000 0001 2287 2027) 
6  Indiana University School of Medicine, Department of Psychiatry, Indianapolis, USA (GRID:grid.257413.6) (ISNI:0000 0001 2287 3919) 
7  Center for Translational Science and Innovation, Center of Health Innovation and Implementation Science, Indianapolis, USA (GRID:grid.257413.6) 
8  Regenstrief Institute, IU Center of Aging Research, Indianapolis, USA (GRID:grid.448342.d) (ISNI:0000 0001 2287 2027); Indiana University School of Medicine, Division of Geriatrics and General Internal Medicine, Department of Internal Medicine, Indianapolis, USA (GRID:grid.257413.6) (ISNI:0000 0001 2287 3919) 
9  Center for Translational Science and Innovation, Center of Health Innovation and Implementation Science, Indianapolis, USA (GRID:grid.257413.6); Eskenazi Hospital, Sandra Eskenazi Center for Brain Care Innovation, Indianapolis, USA (GRID:grid.257413.6); Regenstrief Institute, IU Center of Aging Research, Indianapolis, USA (GRID:grid.448342.d) (ISNI:0000 0001 2287 2027); Indiana University School of Medicine, Division of Geriatrics and General Internal Medicine, Department of Internal Medicine, Indianapolis, USA (GRID:grid.257413.6) (ISNI:0000 0001 2287 3919) 
10  Eskenazi Hospital, Sandra Eskenazi Center for Brain Care Innovation, Indianapolis, USA (GRID:grid.257413.6); Indiana University School of Medicine, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indianapolis, USA (GRID:grid.257413.6) (ISNI:0000 0001 2287 3919); Indiana University School of Medicine, Division of Geriatrics and General Internal Medicine, Department of Internal Medicine, Indianapolis, USA (GRID:grid.257413.6) (ISNI:0000 0001 2287 3919) 
Pages
196
Publication year
2018
Publication date
Dec 2018
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-018-2569-8
ProQuest document ID
2795340908
Copyright
© The Author(s). 2018. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.