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?

In people with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD), reduced capacity for locomotor adaptation is a fundamental but poorly understood mechanism that can be a sensitive biomarker of cognitive-motor impairments. It is also an important therapeutic target for exercise-based interventions to improve walking function. The overall goal of this study is to understand the effects of MCI and AD on locomotor adaptation and walking function.

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.

Is treadmill training safe for people with mild cognitive impairment and Alzheimer's disease?

Research on split-belt treadmill training, which helps people adjust their walking, shows it is generally safe for older adults with mild cognitive impairment and Alzheimer's disease. However, these individuals may have a reduced ability to adapt their walking, which could increase fall risk, so supervision is important. ^{1 2 3 4 5}

How is split-belt treadmill-based locomotor adaptation treatment different from other treatments for Alzheimer's Disease and Mild Cognitive Impairment?

Split-belt treadmill-based locomotor adaptation is unique because it focuses on improving the ability to adjust walking patterns, which is crucial for safe walking and reducing fall risk in people with cognitive impairments. Unlike other treatments that may target cognitive function directly, this approach addresses the physical aspect of gait adaptation, which is often impaired in Alzheimer's Disease and Mild Cognitive Impairment. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment Split-belt treadmill-based locomotor adaptation for Mild Cognitive Impairment and Alzheimer's Disease?

Research shows that split-belt treadmill walking can help assess and potentially improve walking adaptation in people with cognitive impairments, which is linked to better cognitive function. Additionally, exercise programs have been shown to improve mobility and cognitive functions in individuals with mild cognitive impairment. ^{2 4 6 8 9}

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

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

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

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

Benefits of multimodal exercise intervention for postural control and frontal cognitive functions in individuals with Alzheimer's disease: a controlled trial. [2022]

2. Ireland 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. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Locomotor Adaptation Deficits in Older Individuals With Cognitive Impairments: A Pilot Study. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Multimodal exercise intervention improves frontal cognitive functions and gait in Alzheimer's disease: a controlled trial. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Cerebral White Matter Integrity in Amnestic Mild Cognitive Impairment: A 1-Year Randomized Controlled Trial of Aerobic Exercise Training. [2020]

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

Spatial and temporal gait parameters in Alzheimer's disease and aging. [2021]

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

Cardiorespiratory response to exercise testing in individuals with Alzheimer's disease. [2021]

8. Netherlands 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. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Detection and localisation of hesitant steps in people with Alzheimer's disease navigating routes of varying complexity. [2020]