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NCT03197038

Exercise Training and Cognitive Function in Kidney Disease

Completed NA Results posted Last updated 2 July 2021
What this trial tests

NA trial testing Partially supervised home-based walking exercise in Cognitive Function, Preclinical in 39 participants. Completed in 18 December 2019.

Timeline
1 September 2017
Primary endpoint
26 November 2019
18 December 2019

Quick facts

Lead sponsorUniversity of Illinois at Chicago
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment39
Start date1 September 2017
Primary completion26 November 2019
Estimated completion18 December 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Illinois at Chicago

Who can join

Adults 60 to 80, any sex, with Cognitive Function, Preclinical or Chronic Kidney Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Composite Global Cognitive Function Primary · Change from baseline in composite global cognitive function at 6 months

Determine the effect of a 6-month home-based exercise program on composite global cognitive functioning as determined by principal component analysis of immediate free recall of trials 1-5 on California verbal learning II, long-delay free recall and recognition, and memory discriminability, trail making test part A and part B, digit symbol substitution test, semantic and phonemic fluency, and Digit span subtest in older patients with kidney disease and preclinical cognitive impairment. A composite global cognitive score was created by converting the individual cognitive scores to standardized

GroupValue95% CI
Home-based Walking Exercise.15± .37
Control.02± .33
Composite Executive Function Primary · Change from baseline in composite executive function at 6 months

A composite executive functioning score was created by converting 4 individual executive cognitive scores (verbal fluency FAS and animal summary score, digit span backward subtest, and TMT-B) to standardized z scores and then averaging the standardized z scores. A larger change in Z score is considered an improvement.

GroupValue95% CI
Home-based Walking Exercise0.21± .47
Control-.01± .47
White Matter Integrity Secondary · Change from baseline white matter integrity fractional anisotropy at 6 months

Whole brain white matter integrity was created by averaging the fractional anisotropy of 80 tracts using region of interest analysis. An increased change from baseline to 6 months in fractional anisotropy (a measure of directionality, 0 = no principle direction, 1 = one principle direction) is considered an improvement.

GroupValue95% CI
Home-based Walking Exercise-.002± .02
Control.003± .01
Hippocampal Volume - Right Secondary · Change from baseline hippocampal volume at 6 months.

Determine the effect of a 6-month exercise program on hippocampal volume. An increased change from baseline to 6 months in right hippocampal volume in cubic millimeters is considered an improvement.

GroupValue95% CI
Home-based Walking Exercise.003± .0002
Control.003± .003
Cerebral Blood Flow Secondary · Change from baseline in cerebral blood flow at 6 months.

Determine the effect of a 6-month exercise program on cerebral blood flow. Change in global cerebral blood measured in mL/100g/min from baseline to 6 months. An larger change is considered an improvement.

GroupValue95% CI
Home-based Walking Exercise1.6± 9.8
Control0.3± 12.2
Vascular Health - Young's Elastic Modulus Secondary · Change from baseline in vascular health indices at 6 months

Vascular health was assessed by Young's Elastic Modulus (YEM) at the carotid artery. A larger negative change in YEM (measured in kilo pascal, stiffer artery=higher number) from baseline to 6 months is considered an improvement.

GroupValue95% CI
Home-based Walking Exercise-3,175± 9,428
Control1,279± 8,654
Cognitive Function - Total Cognition Secondary · Mean change from baseline to 6 months.

Determine the effect of a 6-month exercise program on cognitive function via the NIH toolbox This composite includes: Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. This composite score is derived by averaging the standard scores of each of the measures, and then deriving standard scores based on this new distribution. An Age-Corrected Standard Score was used. Scale runs 140 to 23, a higher score means a better outcome. An increased change from baseline to 6 months is considered an improvement

GroupValue95% CI
Home-based Walking Exercise8± 7.4
Control11± 7.6
Motor Function - Grip Strength Secondary · Change from baseline in NIH toolbox motor function indices at 6 months

Determine the effect of a 6-month exercise program on motor function via the NIH toolbox. Age corrected grip strength on a standard scale. Standard scale 140-23, higher score is better. An increased change from baseline to 6 months is considered an improvement.

GroupValue95% CI
Home-based Walking Exercise3± 6.2
Control-2.5± 7.2
Vascular Health - Pulse Wave Velocity Secondary · 6 Months

Vascular function indices of vascular health was assessed using pulse wave velocity of the aorta in meters/second (higher number =more stiff aorta). A larger negative change from baseline to 6 months is considered an improvement.

GroupValue95% CI
Home-based Walking Exercise-.01± 1.1
Control.21± .92
Vascular Health - Augmentation Index Secondary · 6 Months

Vascular function indices of vascular health was assessed using augmentation index at the carotid artery (in percentage, higher percent=more stiff artery). A larger negative change from baseline to 6 months is considered an improvement.

GroupValue95% CI
Home-based Walking Exercise-2.6± 12.1
Control3.3± 16.6
Cognitive Function - Fluid Cognition Secondary · Mean change from baseline to 6 months.

Determine the effect of a 6-month exercise program on cognitive function via the NIH toolbox. Fluid cognition. This composite includes: Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. This composite score is derived by averaging the standard scores of each of the measures, and then deriving standard scores based on this new distribution. An Age-Corrected Standard Score was used. A larger change from baseline to 6 months is considered an improvement. Scale runs 140 to 23, a higher score means a better outcome.

GroupValue95% CI
Home-based Walking Exercise5.2± 12.2
Control11± 8.9
Cognitive Function - Crystalized Cognition Secondary · Mean change from baseline to 6 months.

Change from baseline in NIH toolbox cognitive function indices at 6 months. Crystalized cognition. This composite includes : Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. This composite score is derived by averaging the standard scores of each of the measures, and then deriving standard scores based on this new distribution. An Age-Corrected Standard Score was used. An larger change from baseline to 6 months is considered an improvement. Scale runs 140 to 23, a higher score means a better outcome.

GroupValue95% CI
Home-based Walking Exercise7.7± 7.5
Control8.3± 7.1

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Home-based Walking Exercise
Serious: 1/22 (5%)
Deaths: 0/22
Control
Serious: 0/17 (0%)
Deaths: 0/17

Serious adverse events (1 terms)

ReactionSystemHome-based Walking ExerciseControl
Transient ischemic attackVascular disorders
Other adverse events (12 terms — click to expand)

ReactionSystemHome-based Walking ExerciseControl
ED visit: non-serious illnessGeneral disorders
ED visit: non-specific chest painCardiac disorders
FallMusculoskeletal and connective tissue disorders
Prostate and hernia surgerySurgical and medical procedures
ED visit - fall with head injuryMusculoskeletal and connective tissue disorders
ED visit - blood pressureCardiac disorders
Dental surgerySurgical and medical procedures
Home repair accidentMusculoskeletal and connective tissue disorders
Urgent care visit: Calf pain, possible DVTVascular disorders
ED visit: feeling of weaknessBlood and lymphatic system disorders
Low ejection fractionCardiac disorders
Calf muscle sorenessMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Transient ischemic attack.

Data from ClinicalTrials.gov NCT03197038 adverse events section.

Sponsor's own description

Chronic kidney disease (CKD), affects over 45% of all individuals over 70 years of age. Patients with moderate CKD have more than a two-fold increased risk of cognitive impairment than those without CKD; furthermore, as many as 20-70% of patients with CKD have established cognitive impairment and overt dementia. The burden of cognitive impairment and dementia leads to functional decline and accelerated loss of independence, contributing to the tremendous individual, societal, and economic burden of CKD (i.e., 20% of Medicare expenditures in adults \>65 years of age). There is no recommended treatment to prevent cognitive decline in CKD patients, and the few medications available for cognitive impairment have only short term modest effects. There is a critical need to evaluate therapies to forestall cognitive impairment, and maintain or improve cognitive functioning in older patients with CKD. To address this need, this study will test the hypothesis that older patients with moderate/severe CKD and pre-clinical cognitive impairment randomized to a 6-month home-based exercise program will improve cognitive function and MRI measured brain structure, compared to a usual care control group. This study will combine an assessment of cognition with MR imaging techniques to fully evaluate brain structure, blood flow, and behavior relationships at a level previously not conducted in this population

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The effect of exercise on vascular health in chronic kidney disease: a systematic review and meta-analysis of randomized controlled trials.
    Davies MD, Hughes F, Sandoo A, Alejmi A, et al · · 2023 · cited 13× · PMID 37733834 · DOI 10.1152/ajprenal.00152.2023
  2. Association of Exercise With Vascular Function in Patients With CKD: A Meta-Analysis of Randomized Controlled Trials.
    Wang H, Xie D, Wu L, Zhao L. · · 2022 · cited 8× · PMID 35872793 · DOI 10.3389/fmed.2022.904299
  3. Cognitive and vascular function in older adults with and without CKD.
    Hannan M, Collins EG, Phillips SA, Quinn L, et al · · 2021 · cited 5× · PMID 32902822 · DOI 10.1007/s40520-020-01695-w
  4. Exercise Training and Cognitive Function in Kidney Disease: Protocol for a Pilot Randomized Controlled Trial.
    Bronas UG, Hannan M, Lash JP, Ajilore O, et al · · 2022 · cited 3× · PMID 34570042 · DOI 10.1097/nnr.0000000000000554
  5. The Relationship Between Sleep and Brain Function in Older Adults With Chronic Kidney Disease and Self-Identified Cognitive Impairment.
    Hannan M, Jeamjitvibool T, Luo Q, Izci-Balserak B, et al · · 2023 · cited 1× · PMID 37379049 · DOI 10.3928/00989134-20230616-01
  6. Sedentary Behavior in Older Adults With Preclinical Cognitive Impairment With and Without Chronic Kidney Disease.
    Hannan M, Collins EG, Phillips SA, Quinn L, et al · · 2021 · cited 1× · PMID 34044686 · DOI 10.3928/00989134-20210510-02
  7. Physical function, functional capacity, cognition, and brain structure and function in older adults with chronic kidney disease (CKD).
    Hannan MF, Ajilore O, Zhou XJ, Lash JP, et al · · 2025 · PMID 39814616 · DOI 10.1016/j.gerinurse.2024.12.035

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