Treadmill Training for Mild Cognitive Impairment and Alzheimer's Disease

Overseen By Trisha Kesar, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: Antipsychotics, Opioids, Stimulants, others

Disqualifiers: Stroke, Psychotic disorders, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 2 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how walking on a special treadmill can help people with mild cognitive impairment (MCI) and Alzheimer's Disease (AD) improve their walking ability. The focus is on understanding how these conditions affect walking and using treadmill exercises, specifically split-belt treadmill-based locomotor adaptation, as a potential treatment. Participants will engage in treadmill sessions designed to adapt their walking patterns. Ideal candidates have a formal diagnosis of MCI or AD, noticeable memory issues, and can walk at least 10 feet without assistance. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial excludes participants who are on medications that could negatively affect cognition, such as antipsychotics, opioids, stimulants, chemotherapy, and certain drugs for Parkinson's and multiple sclerosis. If you are taking any of these, you may need to stop them to participate.

What prior data suggests that this treadmill-based locomotor adaptation is safe for older adults with MCI and AD?

Research shows that split-belt treadmill training is generally safe for older adults with mild cognitive impairment (MCI) and Alzheimer's Disease (AD). Studies have found that these treadmill sessions help improve walking and are manageable. Evidence suggests that this exercise has been used with older adults without major safety issues. No reports of serious side effects have emerged in these groups, indicating that the treatment is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the split-belt treadmill-based locomotor adaptation because it offers a novel approach to addressing mild cognitive impairment (MCI) and Alzheimer's Disease (AD). Unlike traditional treatments that often involve medications targeting neurotransmitters, this technique leverages physical exercise to potentially enhance brain function and mobility. The split-belt treadmill method aims to improve coordination and cognitive function by creating an adaptive walking experience, which might lead to better outcomes in a shorter time frame. This non-invasive, exercise-based intervention could offer a promising complement or alternative to existing pharmaceutical treatments, potentially resulting in improved quality of life for older adults with MCI and AD.

What evidence suggests that this treadmill-based locomotor adaptation is effective for improving walking function in MCI and AD?

This trial will examine split-belt treadmill-based locomotor adaptation in older adults with mild cognitive impairment (MCI) and Alzheimer's Disease (AD). Research has shown that older adults with MCI and AD struggle to adjust their walking on a split-belt treadmill, where the belts move at different speeds. Practicing on these treadmills can improve balance and coordination over time. Although less evidence exists specifically for people with MCI and AD, similar training has boosted brain function in other groups. Early findings suggest that this treadmill training might alleviate walking difficulties and enhance overall movement in those with MCI and AD. ^{1 3 6 7 8}

Who Is on the Research Team?

Trisha Kesar, PT, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for older adults who can walk without help and have been formally diagnosed with Mild Cognitive Impairment or Alzheimer's Disease by a neurologist. They should not have any medical conditions that affect walking, no recent hospitalizations, and must be able to perform study tasks.

Inclusion Criteria

Persons with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD): AD and MCI defined through formal diagnosis by a board-certified Neurologist using specified criteria including memory concerns, abnormal memory function, specific MMSE score range, CDR score, preserved functional performance, impaired executive function, ability to walk without assistive device, education/work history, and not hospitalized within the last 60 days

I have no health conditions that affect my ability to walk.

Exclusion Criteria

I do not have any major health issues that would prevent me from joining the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-training Evaluation

Participants undergo baseline assessments to evaluate walking function and cognitive performance

1 week

1 visit (in-person)

Treatment

Participants complete 5 split-belt treadmill walking exercise sessions over a 2-week period

2 weeks

5 visits (in-person)

Post-training Evaluation

Participants undergo assessments to evaluate changes in walking function and cognitive performance after training

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Split-belt treadmill-based locomotor adaptation

Trial Overview The study tests how well people with MCI or AD adapt their walking on a split-belt treadmill over five sessions. The goal is to understand the impact of these cognitive conditions on the ability to adjust walking patterns, which could lead to better exercise-based treatments.

How Is the Trial Designed?

Group I: Split-beltTreadmill-based Locomotor Adaptation in Older Adults with MCI Experimental Treatment 1 Intervention

Older adults with mild cognitive impairment (MCI) complete 5 split-belt treadmill walking exercise sessions over a 2-week period.

Group II: Split-beltTreadmill-based Locomotor Adaptation in Older Adults with AD Experimental Treatment 1 Intervention

Older adults with Alzheimer's Disease (AD) complete 5 split-belt treadmill walking exercise sessions over a 2-week period.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A 12-week multimodal physical exercise program significantly improved mobility and executive function in elderly individuals with mild cognitive impairment (MCI), but did not show similar benefits for those with Alzheimer's disease (AD).

The study involved 56 participants (28 in the exercise group and 28 in the control group), and the results suggest that physical exercise can be a beneficial intervention for those in the early stages of neurocognitive disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three months of multimodal training contributes to mobility and executive function in elderly individuals with mild cognitive impairment, but not in those with Alzheimer's disease: A randomized controlled trial. de Oliveira Silva, F., Ferreira, JV., Plácido, J., et al.[2019]

A 16-week home-based multimodal exercise program significantly improved muscle strength and reduced the risk of falls in older adults with mild to moderate Alzheimer's disease, as shown by better performance on the 5X Sit-to-Stand Test and lower fall risk scores.

In contrast, the control group experienced worsening functional limitations and an increased risk of falls, highlighting the effectiveness of the exercise intervention in maintaining and enhancing physical capabilities in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of improving strength and functioning and decreasing the risk of falls in older adults with Alzheimer's dementia: a randomized controlled home-based exercise trial. Cezar, NOC., Ansai, JH., Oliveira, MPB., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9108197/

Locomotor Adaptation Deficits in Older Individuals With ... Our results demonstrated a significant decrease in split-belt locomotor adaptation magnitude in older individuals with MCI and AD compared to HOA.

2. withpower.com withpower.com/trial/phase-mild-cognitive-impairment-mci-6-2024-79e61

Treadmill Training for Mild Cognitive Impairment and ... Research on split-belt treadmill training, which helps people adjust their walking, shows it is generally safe for older adults with mild cognitive impairment ...

3. researchgate.net researchgate.net/publication/360316505_Locomotor_Adaptation_Deficits_in_Older_Individuals_With_Cognitive_Impairments_A_Pilot_Study

(PDF) Locomotor Adaptation Deficits in Older Individuals ... Our results demonstrated a significant decrease in split-belt locomotor adaptation magnitude in older individuals with MCI and AD compared to ...

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/571795

Locomotion Adaptation Deficits in Older Adults With Mild ... Step length symmetry data from the split-belt phase will be used to evaluate each individual's locomotor de-adaptation magnitude capacity by assessing the peak ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35585850/

Locomotor Adaptation Deficits in Older Individuals With ... Our results demonstrated a significant decrease in split-belt locomotor adaptation magnitude in older individuals with MCI and AD compared to HOA.

6. academic.oup.com academic.oup.com/brain/article/130/7/1861/323790

Locomotor adaptation on a split-belt treadmill can improve ... Results showed that stroke involving cerebral structures did not impair either reactive or adaptive abilities and did not disrupt storage of new interlimb ...

7. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2019.00010/full

Effects of Aging and Task Prioritization on Split-Belt Gait ... A split-belt treadmill allows us to study not only the reactive responses, but also locomotor adaptations to a sustained perturbation during ...

8. mdpi.com mdpi.com/2076-3425/13/9/1266

The Influence of Age and Physical Activity on Locomotor ... Our results confirm that locomotor adaptive responses are preserved in aging, but the ability to deadapt newly learnt balance responses is compromised with age.