Motoric Cognitive Risk SyndromeNCT06451874
Personalized Exercise Treatments for Older Veterans With Motoric Cognitive Risk Syndrome
A study testing Functional Power Training (FPT), Music-Based Digital Therapy (MBDT) and FPT + MBDT in people with Motoric Cognitive Risk Syndrome, run by VA Office of Research and Development at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Motoric Cognitive Risk Syndrome
- What is being tested?
- Functional Power Training (FPT), Music-Based Digital Therapy (MBDT) and FPT + MBDT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65
- Receiving VA primary care
- Community-dwelling
- Motoric Cognitive Risky Syndrome i. Slow gait speed ii. Subjective cognitive concerns/complaints
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
Elisa Ogawa, PhD MS BS, 857-364-4011, elisa.ogawa@va.gov
Elisa Ogawa, PhD MS BS
About this study
Official title: 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).
Read the 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.
- Conditions
- Motoric Cognitive Risk Syndrome
- Being tested
- Functional Power Training (FPT), Music-Based Digital Therapy (MBDT), FPT + MBDT
- Keywords
- Veterans, Mobility, Cognition, Sequential Multiple Assignment Randomized Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Power Training (FPT)Behavioural
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)Behavioural
Participants will receive twice weekly MBDT, a technology-driven gait training that is grounded in evidence-based rehabilitation treatment, rhythmic auditory stimulation.
FPT + MBDTBehavioural
For non-responders who were randomized to augment treatment, they will receive combined FPT and MBDT treatment.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 Exercise Treatment | Experimental | Participants will first be randomized to 6-week exercise treatment (FPT or MBDT) Receives: Behavioral: Functional Power Training (FPT); Behavioral: Music-Based Digital Therapy (MBDT) |
| Stage 2: Exercise Treatment | Experimental | 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. Receives: Behavioral: Functional Power Training (FPT); Behavioral: Music-Based Digital Therapy (MBDT); Behavioral: FPT + MBDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment/Baseline
Enrollment will be defined as the number of participants who were recruited and consented to the study.
Measured: Enrollment
Retention
Retention will be defined as the number of participants who completed the 12-week exercise treatment.
Measured: Baseline to end of 12-week treatment
Compliance
Compliance will be defined by the proportion of completed treatment sessions.
Measured: Baseline to end of 12-week treatment
Acceptability
Acceptability will be recorded by conducting interviews with participants who completed the 12-week exercise treatment.
Measured: End of 12-week treatment
Secondary outcomes (1)
Gait Speed
Change in gait speed will be assessed after 12-week exercise treatment.
Measured: Baseline to end of 12-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Jul 2025
- Primary completion31 May 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motoric Cognitive Risk SyndromeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART)
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Elisa Ogawa, PhD MS BS, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451874
- Sponsor's protocol ID
- E5294-W
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motoric Cognitive Risk Syndrome: Refining Treatment Strategies and Testing Feasibility to Personalize Treatment for Older Veterans
- ClinicalTrials.gov ID
- NCT06451874
- Acronym / sponsor ID
- E5294-W
- Conditions
- Motoric Cognitive Risk Syndrome
- Keywords
- Veterans, Mobility, Cognition, Sequential Multiple Assignment Randomized Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART)
| Arm | Type | Receives |
|---|---|---|
| Stage 1 Exercise Treatment | Experimental | Behavioral: Functional Power Training (FPT), Behavioral: Music-Based Digital Therapy (MBDT)Participants will first be randomized to 6-week exercise treatment (FPT or MBDT) |
| Stage 2: Exercise Treatment | Experimental | Behavioral: Functional Power Training (FPT), Behavioral: Music-Based Digital Therapy (MBDT), Behavioral: FPT + MBDTAt 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65
- Receiving VA primary care
- Community-dwelling
- Motoric Cognitive Risky Syndrome i. Slow gait speed ii. Subjective cognitive concerns/complaints
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Power Training (FPT)Participants will receive twice weekly FPT, a progressive functional-based exercises that target optimizing leg force production and leg velocity. | Behavioural | Stage 1 Exercise Treatment, Stage 2: Exercise Treatment |
| 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. | Behavioural | Stage 1 Exercise Treatment, Stage 2: Exercise Treatment |
| FPT + MBDTFor non-responders who were randomized to augment treatment, they will receive combined FPT and MBDT treatment. | Behavioural | Stage 2: Exercise Treatment |
Primary outcome
Enrollment/Baseline
Time frame: Enrollment
Enrollment will be defined as the number of participants who were recruited and consented to the study.
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.
Compliance
Time frame: Baseline to end of 12-week treatment
Compliance will be defined by the proportion of completed treatment sessions.
Acceptability
Time frame: End of 12-week treatment
Acceptability will be recorded by conducting interviews with participants who completed the 12-week exercise treatment.
1 secondary outcome
Gait Speed
Time frame: Baseline to end of 12-week treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elisa Ogawa, PhD MS BS principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Power Training (FPT), Music-Based Digital Therapy (MBDT) and FPT + MBDT in people with Motoric Cognitive Risk Syndrome, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisa Ogawa, PhD MS BS ((857) 364-4011, elisa.ogawa@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment/Baseline (time frame: Enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.