Exercise Training and Cognitive Function in Kidney Disease

NCT03197038 | Completed Results DMC

• 2 other identifiers: 2016-1217P30AG022849
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Conditions

Cognitive Function, Preclinical; Chronic Kidney Diseases; Older Adults

Keywords

Cognitive function; Kidney Disease; Exercise; Older adults

Outcome Measures

Primary Outcomes (2)

• Composite Global Cognitive Function

  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.

  Change from baseline in composite global cognitive function at 6 months

• Composite Executive Function

  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.

  Change from baseline in composite executive function at 6 months

Secondary Outcomes (14)

• White Matter Integrity

  Change from baseline white matter integrity fractional anisotropy at 6 months

• Hippocampal Volume - Right

  Change from baseline hippocampal volume at 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.

Study Arms (2)

Home-based walking exercise

EXPERIMENTAL

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.

Behavioral: Partially supervised home-based walking exercise

Control

ACTIVE COMPARATOR

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.

Behavioral: Control

Interventions

Partially supervised home-based walking exercise BEHAVIORAL

Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.

Home-based walking exercise

Control BEHAVIORAL

Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.

Control

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking men and women
• diagnosed stage 3-5 CKD (eGFR\<60 to 15 ml/min);
• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 34570042 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Dr. Ulf Bronas
• Organization: University of Illinois at Chicago

bronas@uic.edu

312-355-5886

Study Officials

• Ulf G Bronas, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, controlled design with a 1:1 allocation

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 23, 2017
• Study Start: September 1, 2017
• Primary Completion: November 26, 2019
• Study Completion: December 18, 2019
• Last Updated: July 2, 2021
• Results First Posted: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)