Interventions Made to Preserve Cognitive Function Trial (IMPCT) study protocol: a multi-dialysis center 2x2 factorial randomized controlled trial of intradialytic cognitive and exercise training to preserve cognitive function

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Abstract

Background

Kidney disease and dialysis significantly impact cognitive function across the age spectrum. Cognitive training (CT) and/or exercise training (ET) are promising approaches to preserve cognitive function among community-dwelling older adults, but have not been tested for cognition preservation in hemodialysis patients of all ages. In this manuscript, we summarize the protocol for the Interventions Made to Preserve Cognitive Function Trial (IMPCT).

Methods

We will perform a 2 × 2 factorial randomized controlled trial (RCT) of eligible adult (≥18 years) hemodialysis initiates ( n = 200) to test whether intradialytic CT (brain games on a tablet PC), ET (foot peddlers) and combined CT + ET while undergoing hemodialysis preserves executive function compared to standard of care (SC). Participants will engage in the interventions to which they are randomized for 6 months. The primary objective is to compare, among interventions, the 3-month change in executive function measured using the Trail Making Test A (TMTA) and B (TMTB); specifically, executive function is calculated as TMTB-TMTA to account for psychomotor speed. This primary outcome was selected based on findings from our pilot study. The secondary objectives are to compare the risk of secondary cognitive outcomes, ESKD-specific clinical outcomes, and patient-centered outcomes at 3-months and 6-months. All data collection and interventions are conducted in the dialysis center.

Discussion

We hypothesize that receiving intradialytic CT or ET will better preserve executive function than SC but receiving combined CT + ET, will be the most effective intervention. The current trial will be an important step in understanding how intradialytic interventions might preserve cognitive health.

Trial Registration

Clinicaltrials.Gov (Date: 8/6/18): # NCT03616535. Protocol Version: 10 (April 2020). Funding: NIDDK R01DK114074.

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Most cited references 43

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How useful is executive control training? Age differences in near and far transfer of task-switching training.

Julia Karbach, Jutta Kray (2009)

Although executive functions can be improved by training, little is known about the extent to which these training-related benefits can be transferred to other tasks, or whether this transfer can be modulated by the type of training. This study investigated lifespan changes in near transfer of task-switching training to structurally similar tasks and its modulation by verbal self-instructions and variable training, as well as far transfer to structurally dissimilar 'executive' tasks and fluid intelligence. Three age groups (8-10; 18-26; 62-76 years of age) were examined in a pretest-training-posttest design. We found near transfer of task-switching training in all age groups, especially in children and older adults. Near transfer was enhanced in adults and impaired in children when training tasks were variable. We also found substantial far transfer to other executive tasks and fluid intelligence in all age groups, pointing to the transfer of relatively general executive control abilities after training.

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Exergaming and older adult cognition: a cluster randomized clinical trial.

Cay Anderson-Hanley, Paul Arciero, Adam Brickman … (2012)

Dementia cases may reach 100 million by 2050. Interventions are sought to curb or prevent cognitive decline. Exercise yields cognitive benefits, but few older adults exercise. Virtual reality-enhanced exercise or "exergames" may elicit greater participation. To test the following hypotheses: (1) stationary cycling with virtual reality tours ("cybercycle") will enhance executive function and clinical status more than traditional exercise; (2) exercise effort will explain improvement; and (3) brain-derived neurotrophic growth factor (BDNF) will increase. Multi-site cluster randomized clinical trial (RCT) of the impact of 3 months of cybercycling versus traditional exercise, on cognitive function in older adults. Data were collected in 2008-2010; analyses were conducted in 2010-2011. 102 older adults from eight retirement communities enrolled; 79 were randomized and 63 completed. A recumbent stationary ergometer was utilized; virtual reality tours and competitors were enabled on the cybercycle. Executive function (Color Trails Difference, Stroop C, Digits Backward); clinical status (mild cognitive impairment; MCI); exercise effort/fitness; and plasma BDNF. Intent-to-treat analyses, controlling for age, education, and cluster randomization, revealed a significant group X time interaction for composite executive function (p=0.002). Cybercycling yielded a medium effect over traditional exercise (d=0.50). Cybercyclists had a 23% relative risk reduction in clinical progression to MCI. Exercise effort and fitness were comparable, suggesting another underlying mechanism. A significant group X time interaction for BDNF (p=0.05) indicated enhanced neuroplasticity among cybercyclists. Cybercycling older adults achieved better cognitive function than traditional exercisers, for the same effort, suggesting that simultaneous cognitive and physical exercise has greater potential for preventing cognitive decline. This study is registered at Clinicaltrials.gov NCT01167400. Copyright © 2012 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

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Adapting the Charlson Comorbidity Index for use in patients with ESRD.

Brenda R. Hemmelgarn, Hude Quan, William A Ghali … (2003)

Accurate prediction of survival for patients with end-stage renal disease (ESRD) and multiple comorbid conditions is difficult. In nondialysis patients, the Charlson Comorbidity Index has been used to adjust for comorbidity. The purpose of this study is to assess the validity of the Charlson index in incident dialysis patients and modify the index for use specifically in this patient population. Subjects included all incident hemodialysis and peritoneal dialysis patients starting dialysis therapy between July 1, 1999, and November 30, 2000. These 237 patients formed a cohort from which new integer weights for Charlson comorbidities were derived using Cox proportional hazards modeling. Performance of the original Charlson index and the new ESRD comorbidity index were compared using Kaplan-Meier survival curves, change in likelihood ratio, and the c statistic. After multivariate analysis and conversion of hazard ratios to index weights, only 6 of the original 18 Charlson variables were assigned the same weight and 6 variables were assigned a weight higher than in the original Charlson index. Using Kaplan-Meier survival curves, we found that both the original Charlson index and the new ESRD comorbidity index were associated with and able to describe a wide range of survival. However, the new study-specific index had better validated performance, indicated by a greater change in the likelihood ratio test and higher c statistic. This study indicates that the original Charlson index is a valid tool to assess comorbidity and predict survival in patients with ESRD. However, our modified ESRD comorbidity index had slightly better performance characteristics in this population.

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Author and article information

Contributors

Mara A. McAdams-DeMarco:

ORCID: http://orcid.org/0000-0003-3013-925X

mara@jhu.edu

Journal

Journal ID (nlm-ta): BMC Nephrol

Journal ID (iso-abbrev): BMC Nephrol

Title: BMC Nephrology

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2369

Publication date (Electronic): 3 September 2020

Publication date PMC-release: 3 September 2020

Publication date Collection: 2020

Volume: 21

Electronic Location Identifier: 383

Affiliations

[1 ]GRID grid.21107.35, ISNI 0000 0001 2171 9311, Department of Surgery, , Johns Hopkins University School of Medicine, ; Baltimore, MD USA

[2 ]GRID grid.21107.35, ISNI 0000 0001 2171 9311, Department of Epidemiology, , Johns Hopkins Bloomberg School of Public Health, ; 615, N. Wolfe St, W6033, Baltimore, MD 21205 USA

[3 ]GRID grid.21107.35, ISNI 0000 0001 2171 9311, Department of Physical Medicine and Rehabilitation, , Johns Hopkins University School of Medicine, ; Baltimore, MD USA

[4 ]GRID grid.21107.35, ISNI 0000 0001 2171 9311, Department of Mental Health, , Johns Hopkins University School of Medicine, ; Baltimore, MD USA

[5 ]GRID grid.21107.35, ISNI 0000 0001 2171 9311, Department of Medicine, , Johns Hopkins University School of Medicine, ; Baltimore, MD USA

[6 ]GRID grid.21107.35, ISNI 0000 0001 2171 9311, Department of Biostatistics, , Johns Hopkins Bloomberg School of Public Health, ; Baltimore, MD USA

Author information

Mara A. McAdams-DeMarco http://orcid.org/0000-0003-3013-925X

Article

Publisher ID: 2041

DOI: 10.1186/s12882-020-02041-y

PMC ID: 7469421

PubMed ID: 32883245

SO-VID: 03f56e22-7eff-4749-9761-ebab7d49dad9

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 16 May 2020

Date accepted : 23 August 2020

Funding

Funded by: National Institute of Diabetes and Digestive and Kidney Diseases (US)

Award ID: R01DK114074

Custom metadata

ScienceOpen disciplines: Nephrology

Keywords: intradialytic exercise,hemodialysis,cognitive function,executive function

Data availability:

ScienceOpen disciplines: Nephrology

Keywords: intradialytic exercise, hemodialysis, cognitive function, executive function

Interventions Made to Preserve Cognitive Function Trial (IMPCT) study protocol: a multi-dialysis center 2x2 factorial randomized controlled trial of intradialytic cognitive and exercise training to preserve cognitive function

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Abstract

Background

Methods

Discussion

Trial Registration

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Karger: Nephrology

Most cited references 43

How useful is executive control training? Age differences in near and far transfer of task-switching training.

Exergaming and older adult cognition: a cluster randomized clinical trial.

Adapting the Charlson Comorbidity Index for use in patients with ESRD.

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