Walking Exercise for Mild Cognitive Impairment

(EXEC Trial)

Recruiting at 1 trial location

Overseen By Ulf G Bronas, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Antidepressants, Antipsychotics

Disqualifiers: Dementia, Heart failure, Psychiatric disorders, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 6 months

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if walking at home for six months can improve memory and brain health in older adults with mild memory problems and chronic kidney disease. Participants will either follow a home-based walking plan (walking therapy) or receive health education and stretching exercises. The trial seeks individuals with stage 3-4 chronic kidney disease and mild cognitive impairment who can walk unaided and have no history of major head injuries. As an unphased trial, participants contribute to valuable research that may enhance future health recommendations for similar conditions.

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 prior data suggests that home-based walking exercise is safe for older adults with chronic kidney disease and mild cognitive impairment?

Research has shown that exercise, such as walking, is generally safe for people with mild cognitive impairment (MCI). Many studies have found that exercise can enhance brain function in older adults with MCI. Walking is a gentle activity that most people can do without issues.

These studies have not reported specific negative effects from walking. This suggests that walking at home is usually safe and well-tolerated for most individuals. However, it is important to consult a healthcare provider to ensure it suits personal health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of a simple, home-based walking exercise program to improve mild cognitive impairment. Unlike standard treatments that might include medications or cognitive therapy, this program emphasizes physical activity, which is accessible and non-invasive. Participants use a Fitbit to track their progress and receive motivational support, offering a unique blend of technology and exercise to potentially enhance brain health. This trial could reveal an effective, low-cost alternative that empowers individuals to manage their cognitive health through regular, guided exercise.

What evidence suggests that home-based walking exercise might be an effective treatment for mild cognitive impairment?

Research has shown that exercise can improve thinking and memory in people with mild cognitive impairment (MCI). Many studies have found that regular exercise, such as walking, boosts memory and brain function in older adults with MCI. One study discovered that aerobic exercises, like walking, can delay the onset of dementia. Another study found that home-based exercise programs are both practical and effective for enhancing thinking skills in older individuals. In this trial, participants in the home-based walking exercise group will follow a structured walking routine, which may improve memory and brain health in those with MCI. Meanwhile, participants in the health education group will receive health education and perform stretching exercises as a form of attention control. ^{1 2 4 5 6}

Who Is on the Research Team?

Ulf Bronas, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Attention control
• Home-based walking exercise

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.

How Is the Trial Designed?

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+

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The PrAISED intervention, which involved up to 50 therapy sessions focusing on exercise and functional activities for adults with early dementia or mild cognitive impairment, did not show significant improvements in daily living activities, physical activity, or quality of life compared to usual care after 12 months.

Although the intervention group experienced fewer falls (79 falls) compared to the control group (200 falls), the difference was not statistically significant, indicating that the exercise program did not effectively reduce fall risk or improve overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial. Harwood, RH., Goldberg, SE., Brand, A., et al.[2023]

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]

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]

A systematic review of 14 randomized clinical trials found that walking interventions did not significantly improve cognitive function in older adults with mild cognitive impairment (MCI).

However, participants showed a significant improvement in walking endurance, as measured by the 6-minute walk test, indicating that while walking may not enhance cognitive abilities, it can positively affect physical fitness in this population.

NCBI (Pubmed)

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. Lin, JC., Chen, IH., Cheng, FY.[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]

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 home-based exercise program with telephonic coaching was developed for older adults with Motoric Cognitive Risk syndrome, showing that this approach is safe and feasible for promoting exercise participation.

The program had no adverse effects, and participants rated it highly, indicating that personalized and supervised exercise can effectively overcome barriers to physical activity in cognitively impaired individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based exercise program for older adults with Motoric Cognitive Risk syndrome: feasibility study. Ambrose, AF., Gulley, E., Verghese, T., et al.[2021]

Mind-body exercises were found to be the most effective in reducing depressive symptoms in older adults with mild cognitive impairment (MCI), showing a significant improvement compared to controls with a standardized mean difference (SMD) of -0.63 based on a network meta-analysis of 15 randomized controlled trials involving 4271 subjects.

All exercise types, including aerobic and multicomponent exercises, demonstrated comparable benefits in alleviating depression, indicating that various forms of exercise can be beneficial for older adults with MCI, though no significant differences were found between the types.

NCBI (Pubmed)

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. Liu, Q., Ni, W., Zhang, L., et al.[2023]

This systematic review aims to evaluate the effectiveness of physical activity and exercise interventions in improving cognitive and non-cognitive outcomes for adults aged 50 and older with mild cognitive impairment (MCI), with a focus on long-term effects (12+ months).

The study will involve input from people living with MCI to ensure that the outcome measures are relevant to their experiences, and results will be shared with both scientific and general audiences to guide evidence-based exercise recommendations for dementia prevention.

NCBI (Pubmed)

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. Dieckelmann, M., Gonzalez-Gonzalez, AI., Banzer, W., et al.[2022]

A systematic review of 27 studies involving 2565 participants with mild cognitive impairment (MCI) found that physical and mental exercises, such as Tai Chi and dance, significantly improved cognitive performance, as indicated by various cognitive assessment scores.

These exercises not only enhanced cognitive abilities but also positively affected biomarkers, increasing levels of the beneficial αβ1-42 protein and decreasing Tau protein levels, suggesting a potential mechanism for their efficacy in managing MCI.

NCBI (Pubmed)

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. Cai, H., Zhang, K., Wang, M., et al.[2023]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11175880/

Summary of the effect of an exercise intervention on elderly ... Many randomized controlled trials have demonstrated that exercise benefits cognitive function in patients with mild cognitive impairment ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04515563

Effectiveness of Walking Exercise in Improving Cognitive ... This study thus aims to evaluate the effectiveness of the WHO Physical Activity Recommendations in improving cognitive function in older adults with MCI. In ...

3. nature.com nature.com/articles/s41598-023-44771-7

Effectiveness of exercise interventions to improve long ... A growing body of literature reports that exercise and physical activity (EXPA) can slow down the onset of dementia and prevent problems ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1392429/full

Effects of low-intensity home-based exercise on cognition ... This study aimed to compare the effects of 3-month low-intensity home-based exercises, aerobic versus resistance exercises, on cognitive function in people ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0197457222000763

The feasibility and efficacy of the home-based exercise ... To examine the feasibility and efficacy of home-based aerobic and resistance exercise interventions for geriatric individuals with cognitive impairment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10441758/

Review articles (Meta-Analyses) effects of walking on ... Walking intervention has no significant improvement on cognitive functions in older adults with MCI. However, walking induces beneficial effects on aerobic ...