Personalized Exercise Treatments for Older Veterans With Motoric Cognitive Risk Syndrome

Motoric Cognitive Risk Syndrome: Refining Treatment Strategies and Testing Feasibility to Personalize Treatment for Older Veterans

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).

Study Overview

• Status: Recruiting
• Conditions: Motoric Cognitive Risk Syndrome
• Intervention / Treatment: Behavioral: Functional Power Training (FPT); Behavioral: Music-Based Digital Therapy (MBDT); Behavioral: FPT + MBDT

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisa Ogawa, PhD MS BS; Phone Number: (857) 364-4011; Email: elisa.ogawa@va.gov

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130-4817
      • Recruiting
      • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
      • Contact: Elisa Ogawa, PhD MS BS; Phone Number: 857-364-4011; Email: elisa.ogawa@va.gov
      • Principal Investigator: Elisa Ogawa, PhD MS BS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1 Exercise Treatment; Participants will first be randomized to 6-week exercise treatment (FPT or MBDT)	Behavioral: Functional Power Training (FPT); Participants will receive twice weekly FPT, a progressive functional-based exercises that target optimizing leg force production and leg velocity.; 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.
Experimental: 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.	Behavioral: Functional Power Training (FPT); Participants will receive twice weekly FPT, a progressive functional-based exercises that target optimizing leg force production and leg velocity.; 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.; Behavioral: FPT + MBDT; For non-responders who were randomized to augment treatment, they will receive combined FPT and MBDT treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait Speed	Change in gait speed will be assessed after 12-week exercise treatment.	Baseline to end of 12-week treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognition - Executive Function	Change in executive function will be assessed after 12-week exercise treatment using Delis-Kaplan Executive Function System.	Baseline to end of 12-week treatment

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Elisa Ogawa, PhD MS BS, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Veterans; Cognition; Mobility; Sequential Multiple Assignment Randomized Trial
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: E5294-W

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No