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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests personalized exercise programs to help prevent dementia in Veterans at risk. It targets those with Motoric Cognitive Risk syndrome, characterized by slow walking speeds and memory or concentration issues. Participants will initially engage in either Functional Power Training (FPT) or Music-Based Digital Therapy (MBDT). Based on their progress, they may continue with the same treatment or try a combination of both. Veterans who have observed slower walking and memory concerns might be well-suited for this study. As an unphased trial, this study provides Veterans with a unique opportunity to explore innovative therapies tailored to their needs.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Functional Power Training (FPT) and Music-Based Digital Therapy (MBDT) are generally safe and well-tolerated by participants. Studies indicate that FPT improves physical abilities in older adults and is usually safe for them.

Similarly, research has found that music-based therapies, like MBDT, positively affect thinking and memory and are safe for people with dementia. Combining FPT and MBDT might provide extra benefits without adding risks. Specifically, one study on combining exercise and music training showed improvements in both thinking and physical abilities, suggesting it is safe.

In summary, both FPT and MBDT appear to be safe treatments with positive effects on physical and mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Cognitive Risk Syndrome because they offer a personalized approach to improving cognitive function through exercise. Functional Power Training (FPT) focuses on enhancing physical strength and agility, which can directly impact brain health. Meanwhile, Music-Based Digital Therapy (MBDT) uses rhythm and music to stimulate cognitive processes, potentially making the experience enjoyable and engaging. What sets these treatments apart is their focus on individual responsiveness, allowing for adjustments based on a participant's progress, which could lead to more effective and tailored interventions compared to traditional, one-size-fits-all cognitive therapies.

What evidence suggests that this trial's treatments could be effective for Motoric Cognitive Risk syndrome?

Research has shown that Functional Power Training (FPT), one of the treatments in this trial, can significantly enhance physical abilities in older adults, particularly those who are beginning to experience frailty or are already frail. Studies also indicate that FPT can improve mental performance, especially when combined with mental exercises. Music-Based Digital Therapy (MBDT), another treatment option in this trial, has shown promise in enhancing cognitive skills and reducing symptoms in individuals with dementia. This trial will investigate the effects of combining physical exercises like FPT with music-based therapy, as this combination has been beneficial for individuals with mild-to-moderate memory and cognitive issues. ^{1 3 5 6 7}

Who Is on the Research Team?

Elisa Ogawa, PhD MS BS

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-motoric-cognitive-risk-syndrome-2025-1696e

Personalized Exercise Treatments for Cognitive Risk ... Research shows that combining physical exercise with music can improve cognitive function in people with mild-to-moderate dementia. Additionally, a study found ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10475546/

Music-based multicomponent exercise training for community ... We conclude that music-based, multicomponent exercise training can be beneficial for community-dwelling older adults with mild-to-moderate cognitive decline.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10808523/

Effects of remote combine exercise-music training on ... This study aimed to investigate the effects of combined remote music and exercise training on the cognitive, psychological, and physical function of patients ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S266675682500025X

Combined mind–body physical exercise, cognitive training ... The study aimed to compare the effects of: (1) a multi-component intervention: combined cognitive training, mind–body physical exercise, and nurse-led RFM (CPR) ...

5. mdpi.com mdpi.com/2077-0383/14/3/757

Music-Based Cognitive Training for Adults with Major ... This pilot study evaluated the feasibility, acceptability, and preliminary effectiveness of short-term NMT on cognitive function in adults with MDD.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03434496

NCT03434496 | Music Role in PD Rehabilitation The aim of the study was to investigate the central mechanisms of connectivity related to the application of Rhythmic Auditory Stimulation (RAS) in PD gait ...

7. withpower.com withpower.com/trial/phase-depressive-disorder-3-2023-405e4

Music-based Cognitive Training for Depression The provided research does not contain safety data for music-based cognitive training, neurologic music therapy, or music therapy for depression. The studies ...