Personalized Exercise Treatments for Older Veterans With Motoric Cognitive Risk Syndrome

NCT06451874 | Recruiting

• 1 other identifier: E5294-W
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Motoric Cognitive Risk Syndrome

Keywords

Veterans; Mobility; Cognition; Sequential Multiple Assignment Randomized Trial

Outcome Measures

Primary Outcomes (4)

• Enrollment/Baseline

  Enrollment will be defined as the number of participants who were recruited and consented to the study.

  Enrollment

• Retention

  Retention will be defined as the number of participants who completed the 12-week exercise treatment.

  Baseline to end of 12-week treatment

• Compliance

  Compliance will be defined by the proportion of completed treatment sessions.

  Baseline to end of 12-week treatment

• Acceptability

  Acceptability will be recorded by conducting interviews with participants who completed the 12-week exercise treatment.

  End of 12-week treatment

Secondary Outcomes (1)

• Gait Speed

  Baseline to end of 12-week treatment

Other Outcomes (1)

• Cognition - Executive Function

  Baseline to end of 12-week treatment

Study Arms (2)

Stage 1 Exercise Treatment

EXPERIMENTAL

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

Behavioral: Functional Power Training (FPT); Behavioral: Music-Based Digital Therapy (MBDT)

Stage 2: Exercise Treatment

EXPERIMENTAL

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.

Behavioral: Functional Power Training (FPT); Behavioral: Music-Based Digital Therapy (MBDT); Behavioral: FPT + MBDT

Interventions

Functional Power Training (FPT) BEHAVIORAL

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

Stage 1 Exercise Treatment; Stage 2: Exercise Treatment

Music-Based Digital Therapy (MBDT) BEHAVIORAL

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

Stage 1 Exercise Treatment; Stage 2: Exercise Treatment

FPT + MBDT BEHAVIORAL

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

Stage 2: Exercise Treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-English speaking
• Presence of a terminal disease
• Major medical problem
• Myocardial infarction or major surgery in the previous 3 months
• point walking pattern
• Dementia diagnostic
• Mobility disability

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Boston, Massachusetts, 02130-4817, United States

RECRUITING

Study Officials

• Elisa Ogawa, PhD MS BS

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Ogawa, PhD MS BS

CONTACT

(857) 364-4011; elisa.ogawa@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Sequential Multiple Assignment Randomized Trial (SMART)

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 11, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)