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NCT Number: NCT06451874

Personalized Exercise Treatments for Older Veterans With Motoric Cognitive Risk Syndrome

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).

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Key information

Conditions

Motoric Cognitive Risk Syndrome

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Boston, Massachusetts, 02130-4817, United States

Location status: Recruiting

Location contact

Elisa Ogawa, PhD MS BS

CONTACT

[email protected]

857-364-4011

Elisa Ogawa, PhD MS BS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

FPT + MBDT

Behavioral

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

Primary outcomes

  1. Enrollment/Baseline

    Time frame: Enrollment

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

  2. Retention

    Time frame: Baseline to end of 12-week treatment

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

  3. Compliance

    Time frame: Baseline to end of 12-week treatment

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

  4. Acceptability

    Time frame: End of 12-week treatment

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

Secondary outcomes

  1. Gait Speed

    Time frame: Baseline to end of 12-week treatment

    Change in gait speed will be assessed after 12-week exercise treatment.

Other outcomes

  1. Cognition - Executive Function

    Time frame: Baseline to end of 12-week treatment

    Change in executive function will be assessed after 12-week exercise treatment using Delis-Kaplan Executive Function System.

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa Ogawa, PhD MS BS

CONTACT

[email protected]

(857) 364-4011

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 11, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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