Recruiting NCT05655325
Accelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Home-based walking exercise, Attention control.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment, Chronic Kidney Diseases. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 tim - Other Attention control
Health education and stretching
Primary outcome measures
- Change in Executive Function from baseline [Time frame: Change from baseline at 6 months]
- Change in processing speed from baseline [Time frame: Change from baseline at 6 months]
- Change in attention/information processing from baseline [Time frame: Change from baseline at 6 months]
- Change in Learning and Memory short recall [Time frame: Change from baseline at 6 months]
- Change in Learning and Memory long recall [Time frame: Change from baseline at 6 months]
- Change in Learning and Memory learning slope [Time frame: Change from baseline at 6 months]
- Change in Learning and Memory recognition memory discrimination [Time frame: Change from baseline at 6 months]
- Change in global cognitive function [Time frame: Change from Baseline to 6 months]
Secondary outcome measures (5)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Columbia University — New York
Identifiers
NCT: NCT05655325 · AAAU9751 · 2022-0311 · R01AG076456