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临床试验/NCT01308008
NCT01308008已完成不适用

Home Program to Enhance Mobility in Older Veteran Diabetics

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2011年11月最近更新:
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
144
试验地点
2
主要终点
Six Minute Walk Distance

研究概览

简要总结

The goal of the proposed research is to test whether a long-term exercise program in sedentary Veterans with diabetes will produce sustained improvement in mobility performance and physical activity. In this proposed research, 240 sedentary older adult diabetics (aged 60 and over) will be randomly allocated into a customized, primarily home-based, functionally-oriented exercise program with nurse support intervention (I) group versus a flexibility and toning, health education control (C) group, and test outcomes in functional mobility and physical activity at 4 weeks, 6 months and one year. This research can lead to an exercise/PA enhancement program that can coordinate with VA outreach programs, targeting older Veterans who are not in the immediate vicinity of a major VA site. Ultimately, this should create a model to which physicians and other providers could refer comorbid diabetes patients.

详细描述

The goal of the proposed research is to test whether a long-term exercise program in sedentary Veterans with diabetes will produce sustained improvement in mobility performance and physical activity. To facilitate adherence to a long-term program, the investigators plan an individualized, home exercise/physical activity (PA) enhancement program with behavioral support. The rationale for this program is based on: 1) the feasibility of a previously funded VA RR&D controlled trial (led by the present research team) in sedentary older adults with diabetes that improved mobility performance, specifically usual gait speed; 2) the need for longer term and functionally-relevant interventions (specifically mobility-oriented) for older adult diabetics; 3) the potential to use telephonic nurse support to assist in overcoming barriers to exercise and in dealing with intercurrent illness, factors that are key in this comorbid patient group; and 4) the potential to increase the focus on objectively measured physical activity. In this proposed research, 240 sedentary older adult diabetics (aged 60 and over) will be randomly allocated into a customized, primarily home-based, functionally-oriented exercise program with nurse support intervention (I) group versus a flexibility and toning, health education control (C) group, and test outcomes in functional mobility and physical activity at 4 weeks, 6 months and one year.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Sedentary
  • Type 2 Diabetes
  • No medical contraindications to exercise

排除标准

  • Enrolled in intensive exercise program
  • Unable to cooperate with protocol (e.g. cognitive impairment)

研究组 & 干预措施

Functional exercise- home physical activity

Experimental

On-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with telephonic behavioral support

干预措施: home exercise/physical activity (PA) enhancement program with behavioral support (Behavioral)

Flex and tone- home health education

Active Comparator

Initial on-site flex and toning program continued on follow-up along with health education

干预措施: flex and toning health education program (Behavioral)

结局指标

主要结局

Six Minute Walk Distance

时间窗: one year

Walk distance covered in feet over 6 minutes

Comfortable Gait Speed

时间窗: 1 year

Gait velocity over 6 meters

次要结局

  • Physical Activity(one year)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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