Personalized Exercise Treatments for Older Veterans With Motoric Cognitive Risk Syndrome

Motoric Cognitive Risk Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06451874
• Other study ID #: E5294-W
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: December 31, 2029

Study information

• Verified date: June 2024
• Source: VA Office of Research and Development
• Contact: Elisa Ogawa, PhD MS BS
• Phone: (857) 364-4011
• Email: elisa.ogawa[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: December 31, 2029
• Est. primary completion date: May 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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. Use of a walker

6. Dementia diagnostic

7. Mobility disability

Related Conditions & MeSH terms

• Motoric Cognitive Risk Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Enrollment/Baseline	Enrollment will be defined as the number of participants who were recruited and consented to the study.	Enrollment
Primary	Retention	Retention will be defined as the number of participants who completed the 12-week exercise treatment.	Baseline to end of 12-week treatment
Primary	Compliance	Compliance will be defined by the proportion of completed treatment sessions.	Baseline to end of 12-week treatment
Primary	Acceptability	Acceptability will be recorded by conducting interviews with participants who completed the 12-week exercise treatment.	End of 12-week treatment
Secondary	Gait Speed	Change in gait speed will be assessed after 12-week exercise treatment.	Baseline to end of 12-week treatment