Personalized Exercise Treatments for Older Veterans With Motoric Cognitive Risk Syndrome
- Conditions
- Motoric Cognitive Risk Syndrome
- Interventions
- Behavioral: Functional Power Training (FPT)Behavioral: Music-Based Digital Therapy (MBDT)Behavioral: FPT + MBDT
- Registration Number
- NCT06451874
- Lead Sponsor
- VA Office of Research and Development
- 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).
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 54
- Age 65
- Receiving VA primary care
- Community-dwelling
- Motoric Cognitive Risky Syndrome i. Slow gait speed ii. Subjective cognitive concerns/complaints
- Non-English speaking
- Presence of a terminal disease
- Major medical problem
- Myocardial infarction or major surgery in the previous 3 months
- Use of a walker
- Dementia diagnostic
- Mobility disability
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Stage 1 Exercise Treatment Functional Power Training (FPT) Participants will first be randomized to 6-week exercise treatment (FPT or MBDT) Stage 2: Exercise Treatment Music-Based Digital Therapy (MBDT) 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. Stage 2: Exercise Treatment FPT + MBDT 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. Stage 1 Exercise Treatment Music-Based Digital Therapy (MBDT) Participants will first be randomized to 6-week exercise treatment (FPT or MBDT) Stage 2: Exercise Treatment Functional Power Training (FPT) 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.
- Primary Outcome Measures
Name Time Method Enrollment/Baseline Enrollment Enrollment will be defined as the number of participants who were recruited and consented to the study.
Retention Baseline to end of 12-week treatment Retention will be defined as the number of participants who completed the 12-week exercise treatment.
Compliance Baseline to end of 12-week treatment Compliance will be defined by the proportion of completed treatment sessions.
Acceptability End of 12-week treatment Acceptability will be recorded by conducting interviews with participants who completed the 12-week exercise treatment.
- Secondary Outcome Measures
Name Time Method Gait Speed Baseline to end of 12-week treatment Change in gait speed will be assessed after 12-week exercise treatment.
Trial Locations
- Locations (1)
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
🇺🇸Boston, Massachusetts, United States