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临床试验/NCT06451874
NCT06451874招募中不适用

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

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
54
试验地点
2
主要终点
Enrollment/Baseline

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Stage 1 Exercise Treatment

Experimental

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

干预措施: Functional Power Training (FPT) (Behavioral)

Stage 1 Exercise Treatment

Experimental

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

干预措施: Music-Based Digital Therapy (MBDT) (Behavioral)

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.

干预措施: Functional Power Training (FPT) (Behavioral)

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.

干预措施: Music-Based Digital Therapy (MBDT) (Behavioral)

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.

干预措施: FPT + MBDT (Behavioral)

结局指标

主要结局

Enrollment/Baseline

时间窗: Enrollment

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

Retention

时间窗: Baseline to end of 12-week treatment

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

Compliance

时间窗: Baseline to end of 12-week treatment

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

Acceptability

时间窗: End of 12-week treatment

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

次要结局

  • Gait Speed(Baseline to end of 12-week treatment)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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