Clinical trial NCT03197038: Exercise Training and Cognitive Function in Kidney Disease
Official title: Exercise Training and Cognitive Function in Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function, Preclinical
Chronic Kidney Diseases
Older Adults
Keywords: Cognitive function
Kidney Disease
Exercise
Older adults
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-06-23
Enrollment: 39
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled design with a 1:1 allocation
Primary purpose: TREATMENT

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


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,
    * extreme dyspnea on exertion,
    * unstable coronary artery disease;
    * Class III-IV heart failure;
    * Current uncontrolled sustained arrhythmias,
    * severe/symptomatic aortic or mitral stenosis,
    * hypertrophic obstructive cardiomyopathy,
    * severe pulmonary hypertension,
    * active myocarditis/pericarditis,
    * thrombophlebitis,
    * recent systemic/pulmonary embolus (within 3 months);
  * Resting systolic BP \>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.

Primary outcomes:
measure: Composite Global Cognitive Function
timeFrame: Change from baseline in composite global cognitive function at 6 months
measure: Composite Executive Function
timeFrame: Change from baseline in composite executive function at 6 months
Secondary outcomes:
measure: White Matter Integrity
timeFrame: Change from baseline white matter integrity fractional anisotropy at 6 months
measure: Hippocampal Volume - Right
timeFrame: Change from baseline hippocampal volume at 6 months.
measure: Cerebral Blood Flow
timeFrame: Change from baseline in cerebral blood flow at 6 months.
measure: Vascular Health - Young's Elastic Modulus
timeFrame: Change from baseline in vascular health indices at 6 months
measure: Cognitive Function - Total Cognition
timeFrame: Mean change from baseline to 6 months.
measure: Motor Function - Grip Strength
timeFrame: Change from baseline in NIH toolbox motor function indices at 6 months
measure: Vascular Health - Pulse Wave Velocity
timeFrame: 6 Months
measure: Vascular Health - Augmentation Index
timeFrame: 6 Months
measure: Cognitive Function - Fluid Cognition
timeFrame: Mean change from baseline to 6 months.
measure: Cognitive Function - Crystalized Cognition
timeFrame: Mean change from baseline to 6 months.
measure: Motor Function - Balance
timeFrame: 6 Months
measure: Motor Function - Dexterity
timeFrame: 6 Months
measure: Resting Global Connectivity
timeFrame: Change from baseline at 6 months
measure: Hippocampal Volume - Left
timeFrame: Change from baseline at 6 Months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Ulf G Bronas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bronas UG, Hannan M, Lash JP, Ajilore O, Zhou XJ, Lamar M. Exercise Training and Cognitive Function in Kidney Disease: Protocol for a Pilot Randomized Controlled Trial. Nurs Res. 2022 Jan-Feb 01;71(1):75-82. doi: 10.1097/NNR.0000000000000554.