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Walking Exercise for Mild Cognitive Impairment (EXEC Trial)

N/A

Recruiting

Led By Ulf G Bronas, PhD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed stage 3-4 chronic kidney disease (CKD, estimated glomerular filtration rate (eGFR) <60 to 20 ml/min)

55 yrs of age

Must not have

Limited exercise capacity due to claudication, unstable angina, severe arthritis, extreme dyspnea on exertion, unstable coronary artery disease

Class III-IV heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 6 months

Summary

This trial will examine the effects of walking at home on memory, brain structure and function in elderly people with kidney disease and mild cognitive impairment.

Who is the study for?

This trial is for English-speaking adults aged 55 or older with stage 3-4 chronic kidney disease and mild cognitive impairment, but no major head trauma, dementia, severe physical limitations, uncontrolled heart conditions, high blood pressure, or psychiatric disorders requiring medical therapy. Participants must be able to undergo an MRI and not be in a supervised exercise program.

What is being tested?

The study is testing if a 6-month home-based walking exercise can improve memory and brain health compared to receiving health education. It targets older adults with chronic kidney disease who also have mild cognitive issues.

What are the potential side effects?

Since the intervention involves walking exercises at home, side effects may include typical exercise-related risks such as muscle strain or fall injuries. Health education should not pose direct physical side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is moderately to severely reduced.

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I am 55 years old or older.

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I have never had a severe head injury or concussion that made me lose consciousness.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe difficulty exercising due to heart or joint issues.

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I have severe heart failure.

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I need help to walk.

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I do not have a history of severe heart or blood vessel problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Executive Function from baseline

Change in Learning and Memory learning slope

Change in Learning and Memory long recall

+5 more

Secondary study objectives

Change from baseline to 6-months in cerebral blood flow.

Change from baseline to 6-months in hippocampal volume

Change from baseline to 6-months in white matter fractional anisotropy.

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Home-based walking exerciseExperimental Treatment1 Intervention

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 II: Health educationPlacebo Group1 Intervention

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.

0 / 7Eligibility criteria met