Accelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Change in attention/information processing from baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The PI and the outcome assessors are blinded to group assignment
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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
排除标准
- •• 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
研究组 & 干预措施
Home-based walking exercise
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.
干预措施: Home-based walking exercise (Behavioral)
Health education
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.
干预措施: Attention control (Other)
结局指标
主要结局
Change in attention/information processing from baseline
时间窗: Change from baseline at 6 months
Digit symbol substitution test total number correct. Higher number is better.
Change in Learning and Memory long recall
时间窗: Change from baseline at 6 months
California verbal learning test-II long recall total number of words correct. Higher number is better.
Change in Learning and Memory learning slope
时间窗: Change from baseline at 6 months
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
时间窗: Change from baseline at 6 months
California verbal learning test-II recognition memory discrimination total number of words correct. Higher number is better.
Change in Executive Function from baseline
时间窗: Change from baseline at 6 months
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 Learning and Memory short recall
时间窗: Change from baseline at 6 months
California verbal learning test-II, short recall total number of words correct. Higher number is better.
Change in global cognitive function
时间窗: Change from Baseline to 6 months
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 in processing speed from baseline
时间窗: Change from baseline at 6 months
Trail making test part A (TMT-A) time to completion in seconds. Faster completion is better.
次要结局
- Change from baseline to 6-months in hippocampal volume(Change from baseline to 6 months)
- Change from baseline to 6-months in cerebral blood flow.(Change from baseline to 6 months)
- Change from baseline to 6-months in white matter mean diffusivity.(Change from baseline to 6 months)
- Change from baseline to 6-months in white matter fractional anisotropy.(Change from baseline to 6 months)
- Changes from baseline to 6-months in functional connectivity(Change from Baseline to 6 months)
研究者
Shayan Shirazian
Associate Professor of Medicine
Columbia University