Exercise Training and Cognitive Function in Kidney Disease

University of Illinois

Status: Completed

Conditions: Chronic Kidney Diseases; Cognitive Function, Preclinical; Older Adults

Treatments: Behavioral: Control; Behavioral: Partially supervised home-based walking exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03197038

2016-1217

P30AG022849 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Home-based walking exercise

Experimental group

Description:

Home-based exercise program: The exercise training group will participate in an educational session on exercise for CKD. Participants will receive a packet of information with an exercise prescription and a heart rate monitor that monitors the exercise. Participants will be asked to exercise (a brisk walk) at home, 3 times per week, for 30-60 minutes for 24 weeks. Participants will be contacted via phone biweekly or more frequently if they are behind the exercise routine, and the investigators will meet with them monthly to provide encouragement and progression of exercise, and to download the heart rate monitor.

Treatment:

Behavioral: Partially supervised home-based walking exercise

Control

Active Comparator group

Description:

The control group will receive standard instructions on exercise for patients with kidney disease similar to what is commonly done in clinical practice. The control group will not receive an exercise prescription or heart rate monitor. Participants will be contacted via phone biweekly to answer any questions and ensure continued study participation. The control group will not meet with the investigators monthly.

Treatment:

Behavioral: Control