Veterans With Diabetes Mellitus: Improving Physical Activity and Participation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Physical Activity
研究概览
简要总结
The purpose of the study is to investigate if the investigators can improve physical activity and social participation level among Veterans with diabetes.
详细描述
Physical activity is the cornerstone of good diabetes management, and yet effective physical activity intervention is not available. The investigators developed a lifestyle intervention based on individual's home activity patterns. The goal of the study is to test the efficacy of this intervention among Veterans with diabetes in a randomized-controlled trial. In addition to physical activity, the investigators will also assess if the intervention will improve social participation among Veterans.
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
- 否
入选标准
- •Aged 60 years or older
- •Has Type 2 diabetes mellitus
- •Able to operate accelerometer
- •Competent to consent to the study
- •No dementia diagnosis
- •Ambulatory with or without assistive device
- •English-speaking
- •Community living (i.e., not a nursing home resident)
- •Not physically active on a regular basis (less than 150 minutes of moderate or vigorous physical activity per week)
排除标准
- •Medically unstable
- •Hospitalized within the last 6 months
- •2 or more days of complete bed rest in the last month
- •hemiplegia or limb amputation
- •Self-reported illness or conditions that would impair the cooperation with the study team or the ability to complete the study
- •work involved in shift schedule
- •current enrollment of a physical activity program
- •replacement of hip or knee within the last 6 months.
- •Parkinson's disease
- •frequent falls
结局指标
主要结局
Physical Activity
时间窗: 6 months
Home physical activity changes from baseline to 6-months.Physical activity was measured using a validated survey called CHAMPS, asking the participants to report activities that they participated in a typical week, such as walking, doing house work, dancing, etc.
Social Participation
时间窗: 6 months
Survey questionnaires of participation change from baseline to 6-months follow up, specifically, satisfaction with participation in social roles, satisfaction with participation in discretionary social activities, and ability to participate in social roles and activities. Each survey has been validated and scored on the T-score metrics. A T-score is a standardized score, and has a "middle" score; it is 50 for T-scores. This middle score is the mean of a large sample that is representative of the US general population. The survey results are T-score metrics in which 50 is the mean score of the general population and 10 is the standard deviation (SD) of that population. The study outcomes are changes in T-scores of each survey from baseline to 6-months follow-up, where positive score means improved outcome, and negative score means worse outcome at 6-months.
次要结局
未报告次要终点