NCT05655325 · Columbia University
Accelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity
(EXEC)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
OTHER
Attention control
Health education and stretching
Primary outcome measures
Change in Executive Function from baseline
Time frame: Change from baseline at 6 months
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.
Change in processing speed from baseline
Time frame: Change from baseline at 6 months
Trail making test part A (TMT-A) time to completion in seconds. Faster completion is better.
Change in attention/information processing from baseline
Time frame: Change from baseline at 6 months
Digit symbol substitution test total number correct. Higher number is better.
Change in Learning and Memory short recall
Time frame: Change from baseline at 6 months
California verbal learning test-II, short recall total number of words correct. Higher number is better.
Change in Learning and Memory long recall
Time frame: Change from baseline at 6 months
California verbal learning test-II long recall total number of words correct. Higher number is better.
Change in Learning and Memory learning slope
Time frame: Change from baseline at 6 months
California verbal learning test-II leaning slope (average number of new words recalled during five consecutive learning trials). Higher number is better.
Change in Learning and Memory recognition memory discrimination
Time frame: Change from baseline at 6 months
California verbal learning test-II recognition memory discrimination total number of words correct. Higher number is better.
Change in global cognitive function
Time frame: Change from Baseline to 6 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations