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

Mild Cognitive Impairment Clinical Trial

— EXEC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05655325
• Other study ID #: AAAU9751
• Secondary ID: 2022-0311
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: January 2024
• Source: Columbia University
• Contact: Ulf G Bronas, PhD
• Phone: 212-305-0750
• Email: ub2154[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Cognitive Dysfunction
• Kidney Diseases
• Mild Cognitive Impairment
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline at 6 months
Primary	Change in processing speed from baseline	Trail making test part A (TMT-A) time to completion in seconds. Faster completion is better.	Change from baseline at 6 months
Primary	Change in attention/information processing from baseline	Digit symbol substitution test total number correct. Higher number is better.	Change from baseline at 6 months
Primary	Change in Learning and Memory short recall	California verbal learning test-II, short recall total number of words correct. Higher number is better.	Change from baseline at 6 months
Primary	Change in Learning and Memory long recall	California verbal learning test-II long recall total number of words correct. Higher number is better.	Change from baseline at 6 months
Primary	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.	Change from baseline at 6 months
Primary	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.	Change from baseline at 6 months
Primary	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.	Change from Baseline to 6 months
Secondary	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.	Change from baseline to 6 months
Secondary	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.	Change from baseline to 6 months
Secondary	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.	Change from Baseline to 6 months
Secondary	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.	Change from baseline to 6 months
Secondary	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.	Change from baseline to 6 months