Exercise Training and Cognitive Function in Kidney Disease

NCT ID: NCT03197038

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-12-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home-based walking exercise

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.

Group Type: EXPERIMENTAL

Partially supervised home-based walking exercise

Intervention Type: 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.

Control

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: 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.

Interventions

Partially supervised home-based walking exercise

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.

Intervention Type: BEHAVIORAL

Control

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Ulf G. Bronas

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulf G Bronas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34570042 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P30AG022849

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016-1217

Identifier Type: -

Identifier Source: org_study_id