Personalized Exercise Treatments for Cognitive Risk Syndrome

Overseen By Elisa Ogawa, PhD MS BS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Terminal disease, Major medical problem, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

54 Participants Needed

Trial Summary

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment FPT + MBDT for Cognitive Risk Syndrome?

Research shows that combining physical exercise with music can improve cognitive function in people with mild-to-moderate dementia. Additionally, a study found that physical exercise can enhance global cognition and brain structure, while music-based exercise is feasible and potentially effective for those with cognitive decline. ^{1 2 3 4 5}

Is personalized exercise treatment safe for humans?

The studies suggest that exercise interventions, including resistance and aerobic training, are generally safe for older adults, as they focus on improving cognitive function and physical fitness without reporting significant adverse effects. ^{6 7 8 9 10}

How is the treatment FPT + MBDT unique for Cognitive Risk Syndrome?

The treatment combines Functional Power Training (FPT) and Music-Based Digital Therapy (MBDT), which is unique because it integrates physical exercise with music therapy to potentially enhance cognitive function. This approach is different from traditional treatments that often focus solely on either physical or cognitive training, offering a novel way to address cognitive risk by targeting both physical and mental aspects simultaneously. ^{8 9 11 12 13}

What is the purpose of this trial?

This study will begin to evaluate personalized preventative dementia treatments for Veterans at risk for developing dementia. The investigators will target Veterans with Motoric Cognitive Risk syndrome (MCR), which is characterized by slow gait speed and cognitive concerns (e.g., problems with memory or concentrations).

Research Team

Elisa Ogawa, PhD MS BS

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Eligibility Criteria

This trial is for veterans aged 65 or older who are under VA primary care, live in the community, and have Motoric Cognitive Risk syndrome—meaning they walk slowly and have memory or concentration issues. It's not for those with terminal diseases, recent major surgery or heart attacks, dementia diagnoses, severe medical problems, mobility disabilities, or non-English speakers.

Inclusion Criteria

I am 65 years old.

Receiving VA primary care

Community-dwelling

Exclusion Criteria

Dementia diagnostic

I have difficulty moving around.

Presence of a terminal disease

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Exercise Treatment

Participants are randomized to a 6-week exercise treatment (Functional Power Training or Music-Based Walking Training)

6 weeks

Stage 2 Exercise Treatment

At 6 weeks, responsiveness is evaluated. Responders continue with their assigned treatment, while non-responders are randomized to either continue or switch to a combined treatment for an additional 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• FPT + MBDT
• Functional Power Training (FPT)
• Music-Based Digital Therapy (MBDT)

Trial Overview The study tests personalized preventative treatments for dementia risk in veterans with MCR. Interventions include Functional Power Training (FPT), Music-Based Digital Therapy (MBDT), and a combination of both to see which helps improve gait speed and cognitive concerns.

Participant Groups

Group I: Stage 2: Exercise Treatment Experimental Treatment 3 Interventions

At 6-week, responsiveness (change in gait speed = 0.05 m/s) will be evaluated. Responders will continue with their assigned treatment and non-responders will be randomized to either continue assigned treatment or combined treatment for an additional 6 weeks.

Group II: Stage 1 Exercise Treatment Experimental Treatment 2 Interventions

Participants will first be randomized to 6-week exercise treatment (FPT or MBDT)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

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]

This study will investigate the effects of a 24-week resistance exercise program on executive function in 90 cognitively normal older adults aged 65-80, aiming to determine if physical exercise can improve cognitive decline associated with aging.

The trial will assess various outcomes, including changes in brain structure, function, and molecular biomarkers, to understand the mechanisms by which resistance exercise may benefit cognitive health and potentially reduce dementia risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active Gains in brain Using Exercise During Aging (AGUEDA): protocol for a randomized controlled trial. Solis-Urra, P., Molina-Hidalgo, C., García-Rivero, Y., et al.[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]

The neuromotor multicomponent training program (MCTP) significantly improved executive function and functional fitness in 56 older women over a 30-week period, showing better results than both control groups in tests like the Stroop test and Timed Up and Go test.

MCTP also positively impacted body composition and health-related quality of life (HRQOL), while both exercise groups (MCTP and CONTROL-EXE) experienced reductions in blood pressure, indicating its overall health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

120 min/week of neuromotor multicomponent training are enough to improve executive function and functional fitness in older women. Martinez-Navarro, I., Cordellat, A., Roldán, A., et al.[2021]

A 6-month randomized controlled trial will assess the effects of aerobic training (AT), resistance training (RT), and their combination on cognitive function in 216 older adults (ages 65-85) with mild cognitive impairment (MCI).

The study aims to determine how different types of exercise can help prevent cognitive decline and potentially delay the onset of dementia, highlighting the importance of exercise as a therapeutic intervention for cognitive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reshaping the path of mild cognitive impairment by refining exercise prescription: a study protocol of a randomized controlled trial to understand the "what," "for whom," and "how" of exercise to promote cognitive function. Barha, CK., Falck, RS., Best, JR., et al.[2022]

A pilot study involving 16 older adults with mild cognitive impairment showed that a 12-week music therapy intervention significantly improved various cognitive functions, including attention, immediate and delayed memory, and executive function.

The study also found improvements in gait parameters, such as gait velocity and stride length, indicating that music therapy may be an effective and innovative approach to enhance both cognitive and physical abilities in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy intervention in community-dwelling older adults with mild cognitive impairment: A pilot study. Domínguez-Chávez, CJ., Murrock, CJ., Guerrero, PIC., et al.[2019]

In a study involving 69 young adults, both high-intensity functional training (HIFT) and moderate-intensity continuous training (MICT) significantly improved cognitive function, particularly in tasks measuring executive function and selective attention, as shown by faster response times and more correct answers on the Stroop Test.

No significant cognitive improvements were observed in the control group, indicating that both HIFT and MICT can positively influence cognitive performance immediately after exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Effects of High-Intensity Functional Training and Moderate-Intensity Continuous Training on Cognitive Functions in Young Adults. de Diego-Moreno, M., Álvarez-Salvago, F., Martínez-Amat, A., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Function and Brain Atrophy Predict Non-pharmacological Efficacy in Dementia: The Mihama-Kiho Scan Project2. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Music-based multicomponent exercise training for community-dwelling older adults with mild-to-moderate cognitive decline: a feasibility study. [2023]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Contribution of a multicomponent intervention on functional capacity and independence on activities of daily living in individuals with neurocognitive disorder. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Therapeutically relevant structural and functional mechanisms triggered by physical and cognitive exercise. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Active Gains in brain Using Exercise During Aging (AGUEDA): protocol for a randomized controlled trial. [2023]

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

120 min/week of neuromotor multicomponent training are enough to improve executive function and functional fitness in older women. [2021]

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

Reshaping the path of mild cognitive impairment by refining exercise prescription: a study protocol of a randomized controlled trial to understand the "what," "for whom," and "how" of exercise to promote cognitive function. [2022]

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

Music therapy intervention in community-dwelling older adults with mild cognitive impairment: A pilot study. [2019]

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

Clinical Effectiveness of Cognitively Enhanced Tai Ji Quan Training on Global Cognition and Dual-Task Performance During Walking in Older Adults With Mild Cognitive Impairment or Self-Reported Memory Concerns : A Randomized Controlled Trial. [2023]

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

Using intraindividual variability as an indicator of cognitive improvement in a physical exercise intervention of older women with mild cognitive impairment. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Acute Effects of High-Intensity Functional Training and Moderate-Intensity Continuous Training on Cognitive Functions in Young Adults. [2023]