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

NCT ID: NCT05655325

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-18

Study Completion Date

2027-02-01

Brief Summary

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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

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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.

Conditions

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Mild Cognitive Impairment Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The PI and the outcome assessors are blinded to group assignment

Study Groups

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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.

Group Type EXPERIMENTAL

Home-based walking exercise

Intervention Type BEHAVIORAL

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 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.

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.

Group Type PLACEBO_COMPARATOR

Attention control

Intervention Type OTHER

Health education and stretching

Interventions

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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 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.

Intervention Type BEHAVIORAL

Attention control

Health education and stretching

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role lead

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Responsible Party

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Ulf Bronas

Professor of Biobehavioral Science (in Nursing)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulf G Bronas, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ulf G Bronas, PhD

Role: CONTACT

212-305-0750

Facility Contacts

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Ulf Bronas, PhD

Role: primary

Other Identifiers

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2022-0311

Identifier Type: OTHER

Identifier Source: secondary_id

R01AG076456

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAU9751

Identifier Type: -

Identifier Source: org_study_id

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