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NCT Number: NCT05655325

Accelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity

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.

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Key information

Conditions

Mild Cognitive Impairment Behavior Chronic Disease Chronic Kidney Diseases Cognition Disorders Cognitive Dysfunction Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Mental Disorders Motor Activity Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgetown University, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based walking exercise

Behavioral

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

Other

Health education and stretching

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. Change from baseline to 6-months in white matter fractional anisotropy.

    Time frame: Change from baseline to 6 months

    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.

  2. Change from baseline to 6-months in white matter mean diffusivity.

    Time frame: Change from baseline to 6 months

    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.

  3. Changes from baseline to 6-months in functional connectivity

    Time frame: Change from Baseline to 6 months

    Quantify change from baseline to 6-months in functional connectivity using functional MRI (fMRI). Range 0-1. Higher score is better.

  4. Change from baseline to 6-months in cerebral blood flow.

    Time frame: Change from baseline to 6 months

    Quantify changes from baseline to 6-months in cerebral blood flow using perfusion MRI arterial spin labeling in mL/100g/min. Higher is better.

  5. Change from baseline to 6-months in hippocampal volume

    Time frame: Change from baseline to 6 months

    Quantify change from baseline to 6-months in hippocampal volume using morphometry using 3D T1-weighted MRI in milliliters cubed. Higher number is better.

Study contacts

Contact information is provided by the study sponsor or research team.

Ulf G Bronas, PhD

CONTACT

[email protected]

212-305-0750

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Georgetown University
  • National Institute on Aging (NIA)

Registry information

Acronym: EXEC

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2022
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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