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Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial.
Trials. 2018 Mar 27; 19(1):196.T

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.

Authors+Show Affiliations

Department of Psychiatry, Indiana University School of Medicine, 355 W 16th Street, Suite 4800 GH, Room 4250, Indianapolis, IN, 46202, USA. sophwang@iupui.edu. Center of Health Innovation and Implementation Science, Center for Translational Science and Innovation, Indianapolis, IN, USA. sophwang@iupui.edu. Sandra Eskenazi Center for Brain Care Innovation, Eskenazi Hospital, Indianapolis, IN, USA. sophwang@iupui.edu.College of Arts and Sciences, Indiana University Bloomington, Bloomington, IN, USA.Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA.IU Center of Aging Research, Regenstrief Institute, Indianapolis, IN, USA.IU Center of Aging Research, Regenstrief Institute, Indianapolis, IN, USA.Department of Psychiatry, Indiana University School of Medicine, 355 W 16th Street, Suite 4800 GH, Room 4250, Indianapolis, IN, 46202, USA.Center of Health Innovation and Implementation Science, Center for Translational Science and Innovation, Indianapolis, IN, USA.Department of Psychiatry, Indiana University School of Medicine, 355 W 16th Street, Suite 4800 GH, Room 4250, Indianapolis, IN, 46202, USA.IU Center of Aging Research, Regenstrief Institute, Indianapolis, IN, USA. Division of Geriatrics and General Internal Medicine, Department of Internal Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.Center of Health Innovation and Implementation Science, Center for Translational Science and Innovation, Indianapolis, IN, USA. Sandra Eskenazi Center for Brain Care Innovation, Eskenazi Hospital, Indianapolis, IN, USA. IU Center of Aging Research, Regenstrief Institute, Indianapolis, IN, USA. Division of Geriatrics and General Internal Medicine, Department of Internal Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.Sandra Eskenazi Center for Brain Care Innovation, Eskenazi Hospital, Indianapolis, IN, USA. Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA. Division of Geriatrics and General Internal Medicine, Department of Internal Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

29580264

Citation

Wang, Sophia, et al. "Improving Recovery and Outcomes Every Day After the ICU (IMPROVE): Study Protocol for a Randomized Controlled Trial." Trials, vol. 19, no. 1, 2018, p. 196.
Wang S, Hammes J, Khan S, et al. Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial. Trials. 2018;19(1):196.
Wang, S., Hammes, J., Khan, S., Gao, S., Harrawood, A., Martinez, S., Moser, L., Perkins, A., Unverzagt, F. W., Clark, D. O., Boustani, M., & Khan, B. (2018). Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial. Trials, 19(1), 196. https://doi.org/10.1186/s13063-018-2569-8
Wang S, et al. Improving Recovery and Outcomes Every Day After the ICU (IMPROVE): Study Protocol for a Randomized Controlled Trial. Trials. 2018 Mar 27;19(1):196. PubMed PMID: 29580264.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): 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 W, AU - Clark,Daniel O, AU - Boustani,Malaz, AU - Khan,Babar, Y1 - 2018/03/27/ PY - 2017/10/05/received PY - 2018/02/28/accepted PY - 2018/3/28/entrez PY - 2018/3/28/pubmed PY - 2019/4/9/medline 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 SP - 196 EP - 196 JF - Trials JO - Trials VL - 19 IS - 1 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. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03095417 . Registered on 23 March 2017. Last updated on 15 May 2017. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/29580264/Improving_Recovery_and_Outcomes_Every_Day_after_the_ICU__IMPROVE_:_study_protocol_for_a_randomized_controlled_trial_ DB - PRIME DP - Unbound Medicine ER -