An interventional study of Home-based walking exercise and Attention control in Mild Cognitive Impairment and Chronic Kidney Diseases, sponsored by Columbia University. Recruiting at 2 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
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.
Following informed consent, participants will undergo tests for heart health, physical function, memory testing, and brain structure and function using imaging (taking pictures of the brain with an MRI). Following these tests participants are randomized to a home-based walking program or health education for 6 months. Participants are given a fitness tracker and gets ongoing telephone coaching during the 6 months. After 6 months the tests are repeated.
3,845 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 144 is above the median of 64 across 2,810 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosed stage 3-4 chronic kidney disease (CKD, estimated glomerular filtration rate (eGFR) \<60 to 20 ml/min);
Exclusion Criteria:
Diagnosed Dementia or a Clinical Dementia Rating Scale score of \<2, or a MOCA of \<18
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.
Behavioral: Home-based walking exercise
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.
Other: Attention control
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.
Health education and stretching
Change in Executive Function from baseline
Composite score from Phonemic and Semantic Fluency total correct words; Trail Making Test Part B (TMT-B) time to completion; Digit Span subtest backwards total score. The composite executive functioning score will be created by converting these four individual executive cognitive scores (phonemic and Semantic fluency score), digit span backward subtest, and trail making test part B (following directionality conversion)) to standardized z scores and then averaging the standardized z scores. Z-score range from -3 to +3. Higher score is better.
Time frame: Change from baseline at 6 months
Change in processing speed from baseline
Trail making test part A (TMT-A) time to completion in seconds. Faster completion is better.
Time frame: Change from baseline at 6 months
Change in attention/information processing from baseline
Digit symbol substitution test total number correct. Higher number is better.
Time frame: Change from baseline at 6 months
Change in Learning and Memory short recall
California verbal learning test-II, short recall total number of words correct. Higher number is better.
Time frame: Change from baseline at 6 months
Change in Learning and Memory long recall
California verbal learning test-II long recall total number of words correct. Higher number is better.
Time frame: Change from baseline at 6 months
Change in Learning and Memory learning slope
California verbal learning test-II leaning slope (average number of new words recalled during five consecutive learning trials). Higher number is better.
Time frame: Change from baseline at 6 months
Change in Learning and Memory recognition memory discrimination
California verbal learning test-II recognition memory discrimination total number of words correct. Higher number is better.
Time frame: Change from baseline at 6 months
Change in global cognitive function
Composite score from Phonemic and Semantic Fluency total correct words; Trail Making Test Part B time to completion; Digit Span subtest backwards total score; Digit symbol substitution test total correct and trail making test part A time to completion; California verbal learning test-II, short and long recall, leaning slope, recognition memory discrimination total correct. The composite global cognitive score will be created by converting these 10 individual cognitive scores (following directionality change of TMT-A and TMT-B) to standardized z scores and then averaging the standardized z scores. Z score range from -3 to +3. Higher score is better.
Time frame: Change from Baseline to 6 months
Change from baseline to 6-months in white matter fractional anisotropy.
Quantify change from baseline to 6-months in white matter integrity fractional anisotropy using diffusion tensor MRI imaging. Range 0-1. Higher number is better.
Time frame: Change from baseline to 6 months
Change from baseline to 6-months in white matter mean diffusivity.
Quantify change from baseline to 6-months in white matter integrity mean diffusivity using diffusion tensor MRI imaging. Range 0-1. Lower number is better.
Time frame: Change from baseline to 6 months
Changes from baseline to 6-months in functional connectivity
Quantify change from baseline to 6-months in functional connectivity using functional MRI (fMRI). Range 0-1. Higher score is better.
Time frame: Change from Baseline to 6 months
Change from baseline to 6-months in cerebral blood flow.
Quantify changes from baseline to 6-months in cerebral blood flow using perfusion MRI arterial spin labeling in mL/100g/min. Higher is better.
Time frame: Change from baseline to 6 months
Change from baseline to 6-months in hippocampal volume
Quantify change from baseline to 6-months in hippocampal volume using morphometry using 3D T1-weighted MRI in milliliters cubed. Higher number is better.
Time frame: Change from baseline to 6 months
Plan to share: Yes — Individual participant data (IPD) will be made available based on each publication. The PI will share data through sharing requests. All data will be properly de-identified before sharing. Data sharing requests may be granted to those that 1) have a detailed research plan for the requested data, 2) have human subjects training, and 3) have institutional review board (IRB) approval from their home institution. Data sharing requests will be furnished with a data-sharing agreement approved by the University of Illinois Chicago IRB that contains commitments to: 1) Using the data for research purposes only (no commercial use of the data), 2) not attempting to re-identify any participant, 3) securing the data using appropriate technology, and 4) destroying or returning the data after analyses. Other stipulations may be added to the data-sharing agreement if deemed necessary. Data may be shared as a complete or partial dataset depending on the request.
Supporting information: Study protocol, Sap
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