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临床试验/NCT00435188
NCT00435188已完成不适用

Life 2: Improving Fitness and Function in Elders

US Department of Veterans Affairs1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2004年11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
已完成
入组人数
400
试验地点
1
主要终点
Usual Gait Speed

研究概览

简要总结

The purpose of this study is to determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans. The primary physical performance outcome is change in gait speed.

详细描述

Physical inactivity contributes greatly to the health care burden of older adults and is associated with a high prevalence of functional limitations, morbidity, and disability. Rates of physical inactivity are highest among older adults. Older veterans, compared non-veteran older adults, are more likely to be physically inactive and report more limitations in physical function. Increasing physical activity among older veterans is a promising approach to reduce the burden of chronic disease and its associated functional limitations. The purpose of this study is to determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans The primary physical performance outcome is change in gait speed. Secondary objectives include examination of the effect of intervention between the two groups (intervention and usual care) on physical activity, self-reported physical function, and health-related quality of life. We also will estimate health care costs between the two groups to determine the short-term economic impact of the counseling in the VHA. Design. Randomized controlled clinical trial. Data collection. All consented patients will receive a baseline computer assisted interview and physical performance test to be repeated quarterly for one-year. The primary outcome is change in gait speed, which is highly predictive of subsequent institutionalization and mortality. Secondary outcome measures include: the SF-36 physical function and other relevant subscales, health-related quality of life, physical activity, self-efficacy, and personal functional goals. Differences between groups for non-routine outpatient clinic use and hospitalization will be explored. The cost of providing an intensive intervention (relative to the cost of usual care) will be calculated relative to functional changes between groups. Individuals randomized to the intervention group will receive a physical activity counseling intervention that includes four components. We will measure and assess change at each endpoint (3,6,9, 12, and 24 months) to determine short and long-term efficacy. Secondary analyses will include: (a) effect of intervention on self-reported physical function, physical activity, personal functional goals, and self-efficacy, and (b) comparison of outpatient clinic use and hospitalization costs between treatment arms relative to intervention costs. Duration Four years. Relevance to the VA. Because approximately 50% of veterans over age 74 have a limiting disability, it is imperative to explore strategies that will alter the course of functional decline of our aging veterans.

研究设计

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

入排标准

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

入选标准

  • Age 70 or over
  • Followed in VA primary care or geriatrics clinic
  • Currently not regularly physically active
  • Able to walk 10 meters without human assistance (assistive device acceptable)

排除标准

  • Age 70 or over
  • Followed in VA primary care or geriatrics clinic
  • Currently not regularly physically active
  • Able to walk 10 meters without human assistance (assistive device acceptable)
  • A terminal diagnosis

研究组 & 干预措施

Arm 1

Experimental

Behavioral: Multi-component physical activity counseling program A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback

干预措施: Multi-component physical activity counseling program (Behavioral)

Arm 2

No Intervention

Usual care

结局指标

主要结局

Usual Gait Speed

时间窗: 12-month

Rapid Gait Speed

时间窗: 12-month

Usual Gait Speed

时间窗: Baseline

Best of two trials over 8-foot walk

Usual Gait Speed

时间窗: 3 month

Rapid Gait Speed

时间窗: Baseline

Rapid Gait Speed

时间窗: 3-month

次要结局

  • Physical Activity Frequency (CHAMPS Questionnaire)(12 month)
  • Self Rated Health(12 month)
  • Sf-36 Physical Function Subscale(12 month)
  • 2 Minute Walk(12 month)
  • Physical Activity Frequency (CHAMPS Questionnaire)(3 month)
  • Physical Activity Frequency (CHAMPS Questionnaire)(Baseline)
  • Self Rated Health(Baseline)
  • Self Rated Health(3 month)
  • Sf-36 Physical Function Subscale(Baseline)
  • Sf-36 Physical Function Subscale(3 month)
  • 2 Minute Walk(Baseline)
  • 2 Minute Walk(3 month)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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