Personalized Exercise Treatments for Older Veterans With Motoric Cognitive Risk Syndrome

VA Office of Research and Development

Status: Enrolling

Conditions: Motoric Cognitive Risk Syndrome

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

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06451874

E5294-W

Details and patient eligibility

About

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).

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Stage 1 Exercise Treatment

Experimental group

Description:

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

Treatment:

Behavioral: Functional Power Training (FPT)

Behavioral: Music-Based Digital Therapy (MBDT)

Stage 2: Exercise Treatment

Experimental group

Description:

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.

Treatment:

Behavioral: Functional Power Training (FPT)

Behavioral: FPT + MBDT

Behavioral: Music-Based Digital Therapy (MBDT)