Mild Cognitive ImpairmentEXECNCT05655325
Accelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity
A study testing Home-based walking exercise in people with Mild Cognitive Impairment and Chronic Kidney Diseases, run by Columbia University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Chronic Kidney Diseases
- What is being tested?
- Home-based walking exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jun 2024to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Columbia University
New York, New York, 10023
Ulf G Bronas, PhD, ub2154@cumc.columbia.edu
Ulf G Bronas, PhD
- Recruiting
Georgetown University
Washington D.C., District of Columbia, 20057
Ulf Bronas, PhD, (202) 687-3375, ub46@georgetown.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Mild Cognitive Impairment, Chronic Kidney Diseases
- Being tested
- Home-based walking exercise, Attention control
- Keywords
- mild cognitive impairment, chronic kidney disease, exercise, Lifestyle behavior, home-based exercise
- Medical subject headings
- Cognitive Dysfunction, Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based walking exerciseBehavioural
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 controlOther
Health education and stretching
| Study group | Role | What they receive |
|---|---|---|
| Home-based walking exercise | Experimental | 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. Receives: Behavioral: Home-based walking exercise |
| Health education | Placebo comparator | 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. Receives: Other: Attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline at 6 months
Change in attention/information processing from baseline
Digit symbol substitution test total number correct. Higher number is better.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline to 6 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start18 Jun 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial. Participants are randomized following baseline testing using block randomization of 2 and 4 to either an exercise intervention group or a health education group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Georgetown University
- Responsible party
- Principal investigator, Shayan Shirazian, Columbia University
- Investigators
- Ulf G Bronas, PhD, Study chair, Columbia UniversityShayan Shirazian, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655325
- Sponsor's protocol ID
- AAAU9751
- Other IDs
- 2022-0311, R01AG076456
- Acronym
- EXEC
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2022
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity
- ClinicalTrials.gov ID
- NCT05655325
- Acronym / sponsor ID
- EXEC / AAAU9751
- Conditions
- Mild Cognitive Impairment, Chronic Kidney Diseases
- Keywords
- mild cognitive impairment, chronic kidney disease, exercise, Lifestyle behavior, home-based exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Georgetown University
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial. Participants are randomized following baseline testing using block randomization of 2 and 4 to either an exercise intervention group or a health education group
| Arm | Type | Receives |
|---|---|---|
| Home-based walking exercise | Experimental | Behavioral: Home-based walking exerciseA 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. |
| Health education | Placebo comparator | Other: Attention controlThe 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Diagnosed stage 3-4 chronic kidney disease (CKD, estimated glomerular filtration rate (eGFR) <60 to 20 ml/min);
Key exclusion criteria (11 listed)
- • Diagnosed Dementia or a Clinical Dementia Rating Scale score of <2, or a MOCA of <18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based walking exerciseA 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. | Behavioural | Home-based walking exercise |
| Attention controlHealth education and stretching | Other | Health education |
Primary outcome
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.
5 secondary outcomes
Change from baseline to 6-months in white matter fractional anisotropy.
Time frame: Change from baseline to 6 months
Change from baseline to 6-months in white matter mean diffusivity.
Time frame: Change from baseline to 6 months
Changes from baseline to 6-months in functional connectivity
Time frame: Change from Baseline to 6 months
Change from baseline to 6-months in cerebral blood flow.
Time frame: Change from baseline to 6 months
Change from baseline to 6-months in hippocampal volume
Time frame: Change from baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ulf G Bronas, PhD study chair
Columbia University
Shayan Shirazian, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based walking exercise in people with Mild Cognitive Impairment and Chronic Kidney Diseases, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ulf G Bronas, PhD (212-305-0750, ub2154@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Executive Function from baseline (time frame: Change from baseline at 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.