Walking Exercise for Mild Cognitive Impairment
(EXEC Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
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.
12345Is 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.
46789How 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.
48101112Eligibility 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.
+3 more
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.
+8 more
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)
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Illinois at Chicago College of Nursing, 2nd floor Clinical Health Research Laboratories. Bronas Laboratory of Vascular and Cognitive HealthChicago, IL
Columbia UniversityNew York, NY
Loading ...
Who Is Running the Clinical Trial?
University of Illinois at ChicagoLead Sponsor
Columbia UniversityLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Effects of mind-body exercise on cognitive performance in middle-aged and older adults with mild cognitive impairment: A meta-analysis study. [2023]To systematically evaluate the clinical efficacy of physical and mental exercise on cognitive performance in middle-aged people with mild cognitive impairment (MCI).
Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial. [2023]To determine the effectiveness of an exercise and functional activity therapy intervention in adults with early dementia or mild cognitive impairment compared with usual care.
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]This review aimed to examine the effectiveness of exercise on global cognitive function, balance, depression symptoms, and sleep quality in patients with mild cognitive impairment. And systematically retrieved five electronic databases, including the Cochrane library, PubMed, Embase, Web of Science, and PsycINFO, from inception to May 2022. Of 1102 studies, twenty-one studies were included in this meta-analysis. The polled results revealed that exercise could significantly improve global cognitive function (SMD = 0.64, 95%CI: 0.36 to 0.91, Z = 4.56, P
The Use of Home-Based Nonimmersive Virtual Reality to Encourage Physical and Cognitive Exercise in People With Mild Cognitive Impairment: A Feasibility Study. [2022]Individuals with mild cognitive impairment are at risk of cognitive and physical decline. Virtual reality (VR) exercise may provide beneficial physical and cognitive exercise. The objectives of this study were to assess the feasibility and safety of home-based VR exercise and to provide pilot data for physical and cognitive efficacy. Eleven individuals with mild cognitive impairment (seven males/four females, average 78 years old, and average 3 years since diagnosis) performed a 30-min home-based VR exercise program 5 days a week for 6 weeks. The VR platform was successfully installed in participants' homes, and all participants were able to learn the VR program and progress. Participants completed 99% of the prescribed exercise. There were no major adverse events. Most participants enjoyed the VR program and reported physical benefits; fewer reported cognitive benefits. No physical or cognitive outcome measures showed change after 6 weeks. Home-based VR exercise is safe and feasible in individuals with mild cognitive impairment.
SMARTfit Dual-Task Exercise Improves Cognition and Physical Function in Older Adults With Mild Cognitive Impairment: Results of a Community-Based Pilot Study. [2023]Mild cognitive impairment is an intermediate state between the cognitive decline often experienced in normal aging and dementia that affects 15% of Americans over 65 years of age. Our communities have an opportunity to support the development and adoption of evidence-based programs to help older adults preserve cognition and physical function. In partnership with a local urban YMCA in an underserved, predominantly minority neighborhood, we tested the appeal and therapeutic benefits of SMARTfit training among older adults with mild cognitive impairment. The participants reported a positive training experience. After 12 weeks of dual-task training, Trail-Making Test and Stroop Color-Word Interference Test scores improved, as did scores on the Short Physical Performance Battery. Results of our SMARTfit dual-task training intervention are encouraging. Larger randomized controlled trials must further investigate the development, implementation, and therapeutic impacts of SMARTfit dual-task training on cognitive and physical function in aging.
Home-based exercise program for older adults with Motoric Cognitive Risk syndrome: feasibility study. [2021]Aim: We developed a home-based goal-directed exercise program with telephonic coaching to overcome barriers to exercise participation in cognitively impaired older adults. Methods: Six patients with Motoric Cognitive Risk syndrome at high risk for dementia were enrolled, three assigned to goal-directed exercises and three to stretching exercises. All participants underwent an in-person training session followed by a session at home with a telephonic coach. Sessions were supervised by a physiatrist, and exercise programs were personalized. Results: In-person training and remote telephonic coaching support promoted adherence. There were no adverse effects and interventions were rated highly. Participant and logistical barriers were identified that can inform design of home-based clinical trials. Conclusion: Home-based exercises are safe and feasible in older adults with Motoric Cognitive Risk.
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]Exercise and physical activity have been shown to improve cognition for people living with mild cognitive impairment (MCI). There is strong evidence for the benefits of aerobic exercise and medium evidence for participating in regular strength training for people with MCI. However, people living with MCI fall two times as often as those without cognitive impairment and the evidence is currently unknown as to whether balance training for people with MCI is beneficial, as has been demonstrated for older people without cognitive impairment. The aim of this study is to determine whether a balance-focused multimodal exercise intervention improves balance and reduces falls for people with MCI, compared with a control group receiving usual care.
Effects of a specially designed aerobic dance routine on mild cognitive impairment. [2022]Mild cognitive impairment (MCI) is known as a transitional stage or phase between normal aging and dementia. In addition, it is associated with an increased risk of dementia. Research has shown that moderate-intensity exercise is associated with a decreased risk of cognitive impairment. Two recent studies demonstrated that dance interventions are associated with improved cognitive function in the elderly with MCI.
NeuroExercise: The Effect of a 12-Month Exercise Intervention on Cognition in Mild Cognitive Impairment-A Multicenter Randomized Controlled Trial. [2021]Exercise intervention studies in mild cognitive impairment (MCI), a prodromal stage of Alzheimer's disease (AD), have demonstrated inconsistent yet promising results. Addressing the limitations of previous studies, this trial investigated the effects of a 12-month structured exercise program on the progression of MCI. The NeuroExercise study is a multicenter randomized controlled trial across three European countries (Ireland, Netherlands, Germany). Hundred and eighty-three individuals with amnestic MCI were included and were randomized to a 12-month exercise intervention (3 units of 45 min) of either aerobic exercise (AE; n = 60), stretching and toning exercise (ST; n = 65) or to a non-exercise control group (CG; n = 58). The primary outcome, cognitive performance, was determined by an extensive neuropsychological test battery. For the primary complete case (CC) analyses, between-group differences were analyzed with analysis of covariance under two conditions: (1) the exercise group (EG = combined AE and ST groups) compared to the CG and (2) AE compared to ST. Primary analysis of the full cohort (n = 166, 71.5 years; 51.8% females) revealed no between-group differences in composite cognitive score [mean difference (95% CI)], 0.12 [(-0.03, 0.27), p = 0.13] or in any cognitive domain or quality of life. VO2 peak was significantly higher in the EG compared to the CG after 12 months [-1.76 (-3.39, -0.10), p = 0.04]. Comparing the two intervention groups revealed a higher VO2peak level in the aerobic exercise compared to the stretching and toning group, but no differences for the other outcomes. A 12-month exercise intervention did not change cognitive performance in individuals with amnestic MCI in comparison to a non-exercise CG. An intervention effect on physical fitness was found, which may be an important moderator for long term disease progression and warrants long-term follow-up investigations. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT02913053, identifier: NCT02913053.
Comparative efficacy of various exercise interventions on depression in older adults with mild cognitive impairment: A systematic review and network meta-analysis. [2023]Exercise is a promising nonpharmacological treatment for improving depression in older adults with MCI, but it is unclear which exercises are most effective. The objectives of this study were to compare and rank the effectiveness of various exercise interventions for depression in mild cognitive impairment (MCI) and to investigate the effects of exercise on depression.
Review articles (Meta-Analyses) effects of walking on cognitive function in individuals with mild cognitive impairment: a systematic review and meta-analysis. [2023]Mild cognitive impairment (MCI) is the stage between the expected cognitive decline of normal aging and the more serious decline of dementia. Previous studies have shown that regular exercise can improve cognition and physical performance in older adults. Walking is a low-technology and low-cost exercise that has been proven to improve cognition and mobility in healthy elderly individuals. However, no systematic review or meta-analysis has explored whether walking can improve cognitive function in older adults with MCI. This study aimed to explore the effects of walking interventions on cognitive functions in individuals with MCI.
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]Mild cognitive impairment (MCI) is a clinical syndrome characterised by persistent cognitive deficits that do not yet fulfil the criteria of dementia. Delaying the onset of dementia using secondary preventive measures such as physical activity and exercise can be a safe way of reducing the risk of further cognitive decline and maintaining independence and improving quality of life. The aim is to systematically review the literature to assess the effectiveness of physical activity and exercise interventions to improve long-term patient-relevant cognitive and non-cognitive outcomes in people living with MCI, including meta-analyses if applicable.