Back to resultsAccelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity (EXEC)
Primary Purpose
Mild Cognitive Impairment, Chronic Kidney Diseases
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based walking exercise
Attention control
Sponsored by
About this trial
This is an interventional other trial for Mild Cognitive Impairment focused on measuring mild cognitive impairment, chronic kidney disease, exercise, Lifestyle behavior, home-based exercise
Eligibility Criteria
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
Sites / Locations
- Columbia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Home-based walking exercise
Health education
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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 in processing speed from baseline
Trail making test part A (TMT-A) time to completion in seconds. Faster completion is better.
Change in attention/information processing from baseline
Digit symbol substitution test total number correct. Higher number is better.
Change in Learning and Memory short recall
California verbal learning test-II, short recall total number of words correct. Higher number is better.
Change in Learning and Memory long recall
California verbal learning test-II long recall total number of words correct. Higher number is better.
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 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 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.
Secondary Outcome Measures
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 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.
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 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 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05655325
Brief Title
Accelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity
Acronym
EXEC
Official Title
Accelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2023 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Chronic Kidney Diseases
Keywords
mild cognitive impairment, chronic kidney disease, exercise, Lifestyle behavior, home-based exercise
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
The PI and the outcome assessors are blinded to group assignment
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home-based walking exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Health education
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home-based walking exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Attention control
Intervention Description
Health education and stretching
Primary Outcome Measure Information:
Title
Change in Executive Function from baseline
Description
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
Title
Change in processing speed from baseline
Description
Trail making test part A (TMT-A) time to completion in seconds. Faster completion is better.
Time Frame
Change from baseline at 6 months
Title
Change in attention/information processing from baseline
Description
Digit symbol substitution test total number correct. Higher number is better.
Time Frame
Change from baseline at 6 months
Title
Change in Learning and Memory short recall
Description
California verbal learning test-II, short recall total number of words correct. Higher number is better.
Time Frame
Change from baseline at 6 months
Title
Change in Learning and Memory long recall
Description
California verbal learning test-II long recall total number of words correct. Higher number is better.
Time Frame
Change from baseline at 6 months
Title
Change in Learning and Memory learning slope
Description
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
Title
Change in Learning and Memory recognition memory discrimination
Description
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
Title
Change in global cognitive function
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline to 6-months in white matter fractional anisotropy.
Description
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
Title
Change from baseline to 6-months in white matter mean diffusivity.
Description
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
Title
Changes from baseline to 6-months in functional connectivity
Description
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
Title
Change from baseline to 6-months in cerebral blood flow.
Description
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
Title
Change from baseline to 6-months in hippocampal volume
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulf G Bronas, PhD
Phone
212-305-0750
Email
ub2154@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf G Bronas, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulf Bronas, PhD
Email
ub2154@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Ulf Bronas, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
IPD will be made available by the time of online publication based on each manuscript. Data will be available for 10 years.
IPD Sharing Access Criteria
PI will share data through sharing requests and also work with the Program Officer to identify relevant NIH-approved and University of Illinois Chicago data repositories for the data.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 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.
Learn more about this trial
Accelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity
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