Personalized Exercise Treatments for Older Veterans With Motoric Cognitive Risk Syndrome

NCT ID: NCT06451874

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2029-12-31

Brief Summary

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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).

Detailed Description

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This study will involve therapeutic exercise treatments for Veterans with pre-clinical dementia syndrome. Participants will either participate in functional power training, music-based walking training, or a combination of both. The study will use a sequential multiple assignment, randomized trial (SMART) design. Successful completion of this study will lay the foundation for subsequent research trials, contributing to valuable evidence for personalized rehabilitation medicine for older Veterans.

Conditions

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Motoric Cognitive Risk Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Sequential Multiple Assignment Randomized Trial (SMART)
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Stage 1 Exercise Treatment

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

Group Type EXPERIMENTAL

Functional Power Training (FPT)

Intervention Type BEHAVIORAL

Participants will receive twice weekly FPT, a progressive functional-based exercises that target optimizing leg force production and leg velocity.

Music-Based Digital Therapy (MBDT)

Intervention Type BEHAVIORAL

Participants will receive twice weekly MBDT, a technology-driven gait training that is grounded in evidence-based rehabilitation treatment, rhythmic auditory stimulation.

Stage 2: Exercise Treatment

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 Type EXPERIMENTAL

Functional Power Training (FPT)

Intervention Type BEHAVIORAL

Participants will receive twice weekly FPT, a progressive functional-based exercises that target optimizing leg force production and leg velocity.

Music-Based Digital Therapy (MBDT)

Intervention Type BEHAVIORAL

Participants will receive twice weekly MBDT, a technology-driven gait training that is grounded in evidence-based rehabilitation treatment, rhythmic auditory stimulation.

FPT + MBDT

Intervention Type BEHAVIORAL

For non-responders who were randomized to augment treatment, they will receive combined FPT and MBDT treatment.

Interventions

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Functional Power Training (FPT)

Participants will receive twice weekly FPT, a progressive functional-based exercises that target optimizing leg force production and leg velocity.

Intervention Type BEHAVIORAL

Music-Based Digital Therapy (MBDT)

Participants will receive twice weekly MBDT, a technology-driven gait training that is grounded in evidence-based rehabilitation treatment, rhythmic auditory stimulation.

Intervention Type BEHAVIORAL

FPT + MBDT

For non-responders who were randomized to augment treatment, they will receive combined FPT and MBDT treatment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age 65
2. Receiving VA primary care
3. Community-dwelling
4. Motoric Cognitive Risky Syndrome i. Slow gait speed ii. Subjective cognitive concerns/complaints

Exclusion Criteria

1. Non-English speaking
2. Presence of a terminal disease
3. Major medical problem
4. Myocardial infarction or major surgery in the previous 3 months
5. 3-point walking pattern
6. Dementia diagnostic
7. Mobility disability
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisa Ogawa, PhD MS BS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Elisa Ogawa, PhD MS BS

Role: CONTACT

(857) 364-4011

Facility Contacts

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Elisa Ogawa, PhD MS BS

Role: primary

857-364-4011

Other Identifiers

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E5294-W

Identifier Type: -

Identifier Source: org_study_id

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