Clinical trial NCT05655325: Accelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity
Official title: Accelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Chronic Kidney Diseases
Keywords: mild cognitive impairment
chronic kidney disease
exercise
Lifestyle behavior
home-based exercise
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-12-19
Enrollment: 144
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Executive Function from baseline
timeFrame: Change from baseline at 6 months
measure: Change in processing speed from baseline
timeFrame: Change from baseline at 6 months
measure: Change in attention/information processing from baseline
timeFrame: Change from baseline at 6 months
measure: Change in Learning and Memory short recall
timeFrame: Change from baseline at 6 months
measure: Change in Learning and Memory long recall
timeFrame: Change from baseline at 6 months
measure: Change in Learning and Memory learning slope
timeFrame: Change from baseline at 6 months
measure: Change in Learning and Memory recognition memory discrimination
timeFrame: Change from baseline at 6 months
measure: Change in global cognitive function
timeFrame: Change from Baseline to 6 months
Secondary outcomes:
measure: Change from baseline to 6-months in white matter fractional anisotropy.
timeFrame: Change from baseline to 6 months
measure: Change from baseline to 6-months in white matter mean diffusivity.
timeFrame: Change from baseline to 6 months
measure: Changes from baseline to 6-months in functional connectivity
timeFrame: Change from Baseline to 6 months
measure: Change from baseline to 6-months in cerebral blood flow.
timeFrame: Change from baseline to 6 months
measure: Change from baseline to 6-months in hippocampal volume
timeFrame: Change from baseline to 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Ulf G Bronas, PhD
role: PRINCIPAL_INVESTIGATOR
References: