跳至主要内容
临床试验/NCT04026503
NCT04026503已完成不适用

The Live Long Walk Strong Rehabilitation Program: What Features Improve Mobility Skills?

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2021年1月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
151
试验地点
1
主要终点
Walking Speed

研究概览

简要总结

This study was performed to evaluate the efficacy of the Live Long Walk Strong rehabilitation program in Veterans 50 years and older. This study will examine the features of the program that contribute to improved gait speed.

详细描述

This study was a 4 year phase II randomized clinical trial study design. This study will provide important information about the mechanisms that contribute to meaningful improvement in mobility, the benefits of a novel mode of physical therapy care, and the duration of treatment effect.

This study addresses Veterans with slow gait speed beginning in midlife. Slow walking speed is a major health concern for aging Veterans, that independent of disease status, predicts adverse health outcomes. Physical therapy (PT) care is the foundational treatment for slow gait speed, but no standard treatment approach exists. Clinically feasible modes of PT care that provide longer term improvements in gait speed are not established. The investigators developed Live Long Walk Strong , which is a clinically feasible program of PT care that builds upon research identifying novel modes of treatment with greater efficacy than standard care. The investigators have shown proof of concept among civilians and must confirm this among Veterans across a broader age range than was studied previously. Also, it is critical that the investigators define the attributes targeted by which LLWS induces gait speed improvements, not only after treatment ends but after 16 weeks of subsequent follow up. If successful, it will lead to LLWS refinements, establishing it as a rigorously tested model of PT care, that can be implemented across the VHA nationally.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Participants are randomized through block permuted generated lists performed by the study biostatistician.

入排标准

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

入选标准

  • Aged 50 and older
  • Community dwelling
  • Ability to speak and understand English
  • Usual gait speed 0.5 m/s- 1.0 m/s Activity modifications and access to telehealth rehabilitation

排除标准

  • Presence of a terminal disease
  • A major medical problem, unstable chronic condition, or psychiatric disorder that interferes with safe and successful testing and training
  • Myocardial infarction or major surgery in previous 3 months
  • Planned major surgery
  • Baseline short physical performance battery score less than 4
  • Use of a walker
  • Modified mini mental status examination score less than or equal to 77
  • Presence of a significant disease specific impairment such as:
  • peripheral neurologic impairment
  • orthopedic impairment
  • visual impairment

研究组 & 干预措施

Live Long Walk Strong

Experimental

8 week rehabilitation program

干预措施: Live Long Walk Strong rehabilitation program (Other)

8 week wait list control

Active Comparator

8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program

干预措施: Live Long Walk Strong rehabilitation program (Other)

结局指标

主要结局

Walking Speed

时间窗: Randomization to 8 weeks (comparing intervention to wait list)

Walking (gait) speed is assessed as usual walking pace over a 4-meter course.

次要结局

  • Lower Extremity Power(Randomization to 8 weeks (comparing intervention to wait list groups))
  • Trunk Muscle Endurance(Randomization to 8 weeks (comparing intervention to wait list groups))
  • Gait Variability(Randomization to 8 weeks (comparing intervention to wait list groups))

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验