Accelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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
Disqualifiers
• 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
Trial design
Design model
Parallel
Treatments tested in this trial
Home-based walking exercise
BehavioralA 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 interventionHealth education and stretching
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Home-based walking exerciseExperimental treatment 1 intervention
Group B: Health educationPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Change from baseline at 6 months2
Change in processing speed from baseline
Trail making test part A (TMT-A) time to completion in seconds. Faster completion is better.
Time frame
Change from baseline at 6 months3
Change in attention/information processing from baseline
Digit symbol substitution test total number correct. Higher number is better.
Time frame
Change from baseline at 6 months4
Change in Learning and Memory short recall
California verbal learning test-II, short recall total number of words correct. Higher number is better.
Time frame
Change from baseline at 6 monthsSecondary outcomes
1
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.
Time frame
Change from baseline to 6 months2
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.
Time frame
Change from baseline to 6 months3
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.
Time frame
Change from Baseline to 6 months4
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.
Time frame
Change from baseline to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Georgetown University
Collaborator
Source ClinicalTrials.gov