Recruiting

Exercise

Sponsor:

Columbia University

Code:

NCT05655325

Conditions

Mild Cognitive Impairment

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Home-based walking exercise

Attention control

Study Details

Brief summary:

The purpose of this study is to see if 6 months of home-based walking will improve memory, and brain structure and function, compared to health education in older adults that have chronic kidney disease and mild cognitive impairment.

Conditions

Mild Cognitive Impairment

Chronic Kidney Diseases

Study ID

NCT05655325

Start date

Jun 18, 2024

Status verified date

Apr, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • • Diagnosed stage 3-4 chronic kidney disease (CKD, estimated glomerular filtration rate (eGFR) <60 to 20 ml/min);

  • >55 yrs of age
  • Mild cognitive impairment (18-26 on the MOCA)
  • ability to undergo an MR
  • no history of major head trauma (No head trauma/concussion with loss of consciousness)
  • Speaks, reads, writes English

Exclusion Criteria:

  • • Diagnosed Dementia or a Clinical Dementia Rating Scale score of <2, or a MOCA of <18

  • Participating in a supervised exercise program with intent to increase fitness levels 3 days/week,
  • Requires assistive ambulation
  • Limited exercise capacity due to claudication; unstable angina, severe arthritis, extreme dyspnea on exertion, unstable coronary artery disease
  • Class III-IV heart failure
  • History of uncontrolled sustained arrhythmias, severe/symptomatic aortic or mitral stenosis, hypertrophic obstructive cardiomyopathy, severe pulmonary hypertension, active myocarditis/pericarditis, thrombophlebitis, and recent systemic/pulmonary embolus
  • Resting systolic BP >200 mmHg or resting diastolic BP >110 mmHg
  • Any unforeseen illness or disability that would preclude cognitive testing or exercise training
  • One or more contraindication for MRI; cardiac pacemaker, aneurysm clip, cochlear implants, shrapnel, history of metal fragments in eyes, neurostimulators, diagnosed claustrophobia (MRI only)
  • Any self-reported major psychiatric disorders requiring medical therapy (e.g. schizophrenia, bipolar disorder).
  • Self-reported new diagnosis of clinical depression within 3 months of enrollment or unstable clinical depression requiring medication adjustment within 3 months of enrollment

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Home-based walking exercise

A 6-month partially supervised walking exercise training using a tapered approach. Participants begin with exercising (walking) in person, on-site one time per week and 3 times per week at home for a minimum exercise dosage of 30 minutes of accumulated exercise per session during month 1. During month 2, participants will exercise on-site once every other week and 3-4 times per week at home a minimum exercise dosage of 30 minutes of accumulated exercise per session. During months 2-6, participants will exercise at home 4 times per week for a minimum exercise dosage of 30 minutes of accumulated exercise per session and they will receive a phone call every two weeks to help coach and address any problems. Participants will receive a Fitbit fitness tracker that will be used to deliver their personalized exercise program, exercise monitoring, feedback, and motivational messages.

placebo comparator: Health education

The health education group will receive the same amount of contact hours as the intervention group. The attention control group will receive health education and stretching exercises. Participants will be in person, on-site one time per week during month 1 for about 30 minutes. During month 2, participants will attend the health education on-site once every other week for about 30 minutes. During months 2-6 participants will receive a phone call every two weeks to help remind about the health education. Participants will receive a Fitbit fitness tracker that will be used for exercise monitoring.

Interventions

Home-based walking exercise

A 6-month partially supervised walking exercise program using a tapered approach.Participants will begin exercise (walking) at a relatively low intensity and progress to moderate intensity. Intensity will start at 40% and progress as tolerated up to 60-70%. Rating of perceived exertion of 12-14 (fairly light to moderate) will be used to aid intensity (Rating of perceived exertion 6-20 scale). This is an accepted method for achieving desired exercise intensity. Participants will progress over time to exercise 3-4/week for 30-45 minutes. The exercise program may need to be adjusted for (e.g. 10 minutes of exercise 3 times), to achieve the minimum exercise dose of 30 minutes. This will be determined for each individual participants as needed.

Attention control

Health education and stretching

Primary outcome measure

  • Change in Executive Function from baseline [ Time Frame: Change from baseline at 6 months ]
  • Change in processing speed from baseline [ Time Frame: Change from baseline at 6 months ]
  • Change in attention/information processing from baseline [ Time Frame: Change from baseline at 6 months ]
  • Change in Learning and Memory short recall [ Time Frame: Change from baseline at 6 months ]
  • Change in Learning and Memory long recall [ Time Frame: Change from baseline at 6 months ]
  • Change in Learning and Memory learning slope [ Time Frame: Change from baseline at 6 months ]
  • Change in Learning and Memory recognition memory discrimination [ Time Frame: Change from baseline at 6 months ]
  • Change in global cognitive function [ Time Frame: Change from Baseline to 6 months ]

Central Contacts and Locations

Central contacts

Ulf G Bronas, PhD

212-305-0750ub2154@cumc.columbia.edu

Locations

Georgetown University

Recruiting

Washington D.C., District of Columbia, United States, 20057

Contacts

Ulf Bronas, PhD

(202) 687-3375ub46@georgetown.edu

Columbia University

Recruiting

New York, New York, United States, 10023

Contacts

Ulf G Bronas, PhD

ub2154@cumc.columbia.edu

Principal Investigator:

Ulf G Bronas, PhD

More Information

Sponsor

Columbia University

Last update posted

Sep 8, 2026

Last verified

Apr, 2026

Keywords

  • mild cognitive impairment
  • chronic kidney disease
  • exercise
  • Lifestyle behavior
  • home-based exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-09-08.