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Walking Exercise for Mild Cognitive Impairment (EXEC Trial)
N/A
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 6 months
Awards & highlights
EXEC Trial 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.Check my eligibility
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.See study design
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.
EXEC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
EXEC Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Executive Function from baseline
Change in Learning and Memory learning slope
Change in Learning and Memory long recall
+5 moreSecondary outcome measures
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 moreEXEC 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.
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Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
607 Previous Clinical Trials
1,559,212 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,687 Total Patients Enrolled
Ulf G Bronas, PhDPrincipal InvestigatorColumbia University
4 Previous Clinical Trials
240 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have mild problems with memory and thinking, scoring between 18 and 26 on a memory and thinking test called the MOCA.You are able to have a magnetic resonance imaging (MRI) scan.My kidney function is moderately to severely reduced.You have an unexpected illness or disability that would make it difficult for you to do memory tests or exercise.You have a condition or device that makes it unsafe for you to have an MRI scan, such as a pacemaker, metal fragments in your body, or a history of claustrophobia.I was diagnosed with depression or had a change in my depression medication in the last 3 months.You have been diagnosed with severe memory loss or have a low score on memory tests.You are currently doing an exercise program with a coach to get fitter three times a week.I have severe difficulty exercising due to heart or joint issues.I am 55 years old or older.I have severe heart failure.I need help to walk.You have been diagnosed with severe mental illnesses like schizophrenia or bipolar disorder that require medication.I do not have a history of severe heart or blood vessel problems.Your blood pressure is very high when you are resting.I have never had a severe head injury or concussion that made me lose consciousness.
Research Study Groups:
This trial has the following groups:- Group 1: Home-based walking exercise
- Group 2: Health education
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the current enrollment period still open?
"According to clinicaltrials.gov, this medical study is currently not enrolling patients. The trial was first posted on February 1st 2023 and its parameters were last revised on December 8th 2022. Nevertheless, the website advertises 1075 other trials actively recruiting participants right now."
Answered by AI
What objectives is this clinical research attempting to accomplish?
"The primary metric for this clinical trial, assessed over a 6-month period from baseline, is an alteration in the patient's Learning and Memory short recall. Additional secondary outcomes that will be evaluated include functional connectivity via fMRI scans (scored 0 to 1; higher score means better), volume of hippocampal tissue by 3D T1-weighted MRI morphometry (measured in milliliters cubed; larger values suggest positive changes), and white matter fractional anisotropy as determined with diffusion tensor MRI imaging (also scored 0 to 1)."
Answered by AI
Who else is applying?
What site did they apply to?
University of Illinois at Chicago College of Nursing, 2nd floor Clinical Health Research Laboratories. Bronas Laboratory of Vascular and Cognitive Health
What portion of applicants met pre-screening criteria?
Met criteria
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