Walking Exercise for Mild Cognitive Impairment

(EXEC Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Ulf Bronas, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Illinois at Chicago

Must not be taking: Antidepressants, Antipsychotics

Disqualifiers: Dementia, Heart failure, Psychiatric disorders, others

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a major psychiatric disorder or unstable clinical depression, medication adjustments within 3 months of enrollment may affect eligibility.

What data supports the effectiveness of the treatment Walking Exercise for Mild Cognitive Impairment?

Research shows that exercise can significantly improve cognitive function in people with mild cognitive impairment. Studies have found that various forms of exercise, including walking, can enhance cognitive abilities and physical function, making it a promising treatment option. ^{1 2 3 4 5}

Is walking exercise safe for people with mild cognitive impairment?

Research shows that home-based exercise programs, including walking, are generally safe for people with mild cognitive impairment. Studies found no major adverse events, and participants were able to complete the exercises successfully. ^{4 6 7 8 9}

How is home-based walking exercise different from other treatments for mild cognitive impairment?

Home-based walking exercise is unique because it is a low-cost, low-technology treatment that can be done at home, making it accessible and easy to incorporate into daily life. Unlike other treatments that may require special equipment or settings, walking is simple and has been shown to improve cognition and mobility in older adults. ^{4 8 10 11 12}

Research Team

Ulf Bronas, PhD

Principal Investigator

Columbia University

Eligibility Criteria

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.

Inclusion 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.

Exclusion Criteria

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.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo tests for heart health, physical function, memory testing, and brain structure and function using imaging

1-2 weeks

1 visit (in-person)

Treatment

Participants are randomized to a 6-month home-based walking program or health education, with ongoing telephone coaching and use of a Fitbit fitness tracker

6 months

1 visit per week (in-person) in month 1, bi-weekly calls from month 2-6

Follow-up

Participants are monitored for changes in cognitive function, brain structure, and other health metrics

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Attention control (Other)
• Home-based walking exercise (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Home-based walking exercise Experimental Treatment 1 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 education Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Mark I. Rosenblatt

University of Illinois at Chicago

Chief Executive Officer

MD, PhD, MBA, MHA

Jon Radosta

University of Illinois at Chicago

Chief Medical Officer since 2023

MD

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Dr. Katrina Armstrong

Columbia University

Chief Executive Officer

MD from Johns Hopkins University, MS in Epidemiology from Harvard School of Public Health

Dr. Katrina Armstrong

Columbia University

Chief Medical Officer

MD from Harvard Medical School

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

Exercise significantly improves global cognitive function in patients with mild cognitive impairment, with a strong effect size (SMD = 0.64) based on a meta-analysis of 21 studies.

In addition to cognitive benefits, exercise also enhances balance (SMD = 0.62) and reduces symptoms of depression (SMD = -0.37), indicating its potential as a comprehensive intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of exercise on global cognitive function, balance, depression symptoms, and sleep quality in patients with mild cognitive impairment: A systematic review and meta-analysis. Liu, X., Wang, G., Cao, Y.[2023]

Home-based virtual reality (VR) exercise is safe and feasible for individuals with mild cognitive impairment, with participants completing 99% of the prescribed sessions over 6 weeks without major adverse events.

While most participants enjoyed the VR program and reported physical benefits, no significant changes were observed in physical or cognitive outcomes after the 6-week intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Home-Based Nonimmersive Virtual Reality to Encourage Physical and Cognitive Exercise in People With Mild Cognitive Impairment: A Feasibility Study. Sheehy, L., Sveistrup, H., Knoefel, F., et al.[2022]

A 12-week SMARTfit dual-task training program for older adults with mild cognitive impairment led to significant improvements in cognitive tests (Trail-Making Test and Stroop Test) and physical performance (Short Physical Performance Battery).

Participants in the program reported a positive training experience, suggesting that community-based interventions like SMARTfit could be beneficial for preserving cognitive and physical function in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SMARTfit Dual-Task Exercise Improves Cognition and Physical Function in Older Adults With Mild Cognitive Impairment: Results of a Community-Based Pilot Study. Jhaveri, S., Romanyk, M., Glatt, R., et al.[2023]

This study will assess the effectiveness of a 6-month balance-focused multimodal exercise program for 396 individuals with mild cognitive impairment (MCI), aiming to improve balance and reduce fall rates compared to usual care.

The primary outcomes include balance performance and fall rates, with secondary outcomes evaluating physical activity levels, quality of life, and cognition, providing a comprehensive understanding of the intervention's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balance on the Brain: a randomised controlled trial evaluating the effect of a multimodal exercise programme on physical performance, falls, quality of life and cognition for people with mild cognitive impairment-study protocol. Burton, E., Hill, K., Ellis, KA., et al.[2022]

A 3-month aerobic dance routine significantly improved cognitive function in patients with mild cognitive impairment (MCI), particularly enhancing memory and processing speed, as shown by a study involving 60 participants.

The treatment group demonstrated a notable increase in memory scores and a decrease in P300 latency, indicating faster cognitive processing, compared to the control group receiving usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a specially designed aerobic dance routine on mild cognitive impairment. Zhu, Y., Wu, H., Qi, M., et al.[2022]

A 12-month structured exercise program did not lead to significant improvements in cognitive performance for individuals with mild cognitive impairment (MCI) compared to a non-exercise control group, based on a study of 183 participants.

However, the exercise intervention did result in improved physical fitness, as indicated by higher VO2 peak levels in the exercise groups, suggesting that while cognitive benefits were not observed, enhanced physical fitness may play a role in long-term disease progression and should be explored further.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NeuroExercise: The Effect of a 12-Month Exercise Intervention on Cognition in Mild Cognitive Impairment-A Multicenter Randomized Controlled Trial. Stuckenschneider, T., Sanders, ML., Devenney, KE., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of mind-body exercise on cognitive performance in middle-aged and older adults with mild cognitive impairment: A meta-analysis study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of exercise on global cognitive function, balance, depression symptoms, and sleep quality in patients with mild cognitive impairment: A systematic review and meta-analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The Use of Home-Based Nonimmersive Virtual Reality to Encourage Physical and Cognitive Exercise in People With Mild Cognitive Impairment: A Feasibility Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

SMARTfit Dual-Task Exercise Improves Cognition and Physical Function in Older Adults With Mild Cognitive Impairment: Results of a Community-Based Pilot Study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Home-based exercise program for older adults with Motoric Cognitive Risk syndrome: feasibility study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Balance on the Brain: a randomised controlled trial evaluating the effect of a multimodal exercise programme on physical performance, falls, quality of life and cognition for people with mild cognitive impairment-study protocol. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of a specially designed aerobic dance routine on mild cognitive impairment. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

NeuroExercise: The Effect of a 12-Month Exercise Intervention on Cognition in Mild Cognitive Impairment-A Multicenter Randomized Controlled Trial. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Comparative efficacy of various exercise interventions on depression in older adults with mild cognitive impairment: A systematic review and network meta-analysis. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Review articles (Meta-Analyses) effects of walking on cognitive function in individuals with mild cognitive impairment: a systematic review and meta-analysis. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Effectiveness of exercise and physical activity interventions to improve long-term patient-relevant cognitive and non-cognitive outcomes in people living with mild cognitive impairment: a protocol of a systematic review and meta-analysis. [2022]