Exercise Training and Cognitive Function in Kidney Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cognitive Function, Preclinical
- Sponsor
- University of Illinois at Chicago
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Composite Executive Function
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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
Investigators
Ulf G. Bronas
Associate Professor
University of Illinois at Chicago
Eligibility Criteria
Inclusion Criteria
- •English speaking men and women
- •diagnosed stage 3-5 CKD (eGFR\<60 to 15 ml/min);
- •60-80 years of age,
- •self-experienced persistent decline in cognitive capacity determined as self-reported cognitive complaint (i.e., answering "yes" to the question: "Do you feel like your memory or thinking skills have gotten worse recently?" (before any clinical impairment of cognition has occurred)
- •ability to undergo an MRI;
- •no history of major head trauma.
Exclusion Criteria
- •• current/past diagnosis of neurological/psychiatric disorders;
- •any medications to improve cognition or mood;
- •Diagnosed Dementia or a score of \<2 on the mini-cog assessment
- •Ischemic ulcerations or gangrene on the feet or legs;
- •Participating in a supervised exercise program with intent to increase fitness levels 3 days/week,
- •Requires assistive ambulation;
- •Limited exercise capacity due to conditions other than claudication
- •unstable angina,
- •Claudication
- •severe arthritis,
Outcomes
Primary Outcomes
Composite Executive Function
Time Frame: 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.
Composite Global Cognitive Function
Time Frame: 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 z scores and then averaging the standardized z scores. An increase in change from baseline to 6 months is considered an improvement.
Secondary Outcomes
- Hippocampal Volume - Right(Change from baseline hippocampal volume at 6 months.)
- Motor Function - Grip Strength(Change from baseline in NIH toolbox motor function indices at 6 months)
- Hippocampal Volume - Left(Change from baseline at 6 Months)
- Vascular Health - Augmentation Index(6 Months)
- Motor Function - Dexterity(6 Months)
- Cognitive Function - Fluid Cognition(Mean change from baseline to 6 months.)
- Cognitive Function - Crystalized Cognition(Mean change from baseline to 6 months.)
- Motor Function - Balance(6 Months)
- Resting Global Connectivity(Change from baseline at 6 months)
- White Matter Integrity(Change from baseline white matter integrity fractional anisotropy at 6 months)
- Vascular Health - Pulse Wave Velocity(6 Months)
- Cerebral Blood Flow(Change from baseline in cerebral blood flow at 6 months.)
- Vascular Health - Young's Elastic Modulus(Change from baseline in vascular health indices at 6 months)
- Cognitive Function - Total Cognition(Mean change from baseline to 6 months.)