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N/A N=39 Randomized Treatment

Exercise Training and Cognitive Function in Kidney Disease

Cognitive Function, Preclinical · Chronic Kidney Diseases · Older Adults

Enrolled (actual)
39
Serious AEs
2.6%
Results posted
Jul 2021
Primary outcome: Primary: Composite Global Cognitive Function — .15; .02 Z-score

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Partially supervised home-based walking exercise (Behavioral); Control (Behavioral)
Age
Adult, Older Adult · 60+ yrs
Sex
All
Sponsor
University of Illinois at Chicago
Primary completion
Nov 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Composite Global Cognitive Function
.15; .02
PRIMARY
Composite Executive Function
0.21; -.01
SECONDARY
White Matter Integrity
-.002; .003
SECONDARY
Hippocampal Volume - Right
.003; .003
SECONDARY
Cerebral Blood Flow
1.6; 0.3
SECONDARY
Vascular Health - Young's Elastic Modulus
-3,175; 1,279
SECONDARY
Cognitive Function - Total Cognition
8; 11
SECONDARY
Motor Function - Grip Strength
3; -2.5
SECONDARY
Vascular Health - Pulse Wave Velocity
-.01; .21
SECONDARY
Vascular Health - Augmentation Index
-2.6; 3.3
SECONDARY
Cognitive Function - Fluid Cognition
5.2; 11
SECONDARY
Cognitive Function - Crystalized Cognition
7.7; 8.3
SECONDARY
Motor Function - Balance
-6; -8
SECONDARY
Motor Function - Dexterity
1.2; 1.8
SECONDARY
Resting Global Connectivity
.0047; -.0310
SECONDARY
Hippocampal Volume - Left
-.0001; .0

Summary

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

Eligibility Criteria

Inclusion Criteria

  • English speaking men and women
  • diagnosed stage 3-5 CKD (eGFR 200 mmHg or resting diastolic BP >110 mmHg;
  • Revascularization procedures within the previous 6 months;
  • Any unforeseen illness or disability that would preclude exercise testing or training based on patient provider opinion;
  • Pregnancy
  • No diagnosis of CKD
  • One or more contraindication for MRI
  • cardiac pacemaker,
  • aneurysm clip,
  • cochlear implants,
  • shrapnel,
  • history of metal fragments in eyes,
  • neurostimulators,
  • diagnosed claustrophobia.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03197038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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