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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Другое Attention control
  Health education and stretching

Первичные конечные точки

• Change in Executive Function from baseline [Срок оценки: Change from baseline at 6 months]
• Change in processing speed from baseline [Срок оценки: Change from baseline at 6 months]
• Change in attention/information processing from baseline [Срок оценки: Change from baseline at 6 months]
• Change in Learning and Memory short recall [Срок оценки: Change from baseline at 6 months]
• Change in Learning and Memory long recall [Срок оценки: Change from baseline at 6 months]
• Change in Learning and Memory learning slope [Срок оценки: Change from baseline at 6 months]
• Change in Learning and Memory recognition memory discrimination [Срок оценки: Change from baseline at 6 months]
• Change in global cognitive function [Срок оценки: Change from Baseline to 6 months]

Вторичные конечные точки (5)

• Change from baseline to 6-months in white matter fractional anisotropy. [Срок оценки: Change from baseline to 6 months]
• Change from baseline to 6-months in white matter mean diffusivity. [Срок оценки: Change from baseline to 6 months]
• Changes from baseline to 6-months in functional connectivity [Срок оценки: Change from Baseline to 6 months]
• Change from baseline to 6-months in cerebral blood flow. [Срок оценки: Change from baseline to 6 months]
• Change from baseline to 6-months in hippocampal volume [Срок оценки: Change from baseline to 6 months]

Критерии участия

Критерии включения

• • 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

Критерии исключения

• • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Columbia University — New York

Идентификаторы

NCT: NCT05655325 · AAAU9751 · 2022-0311 · R01AG076456

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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