Physical Activity Behavior Change for Older Veterans After Dysvascular Amputation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Retention Rate
研究概览
简要总结
This pilot study will use mobile-health technology to deliver an intervention designed for lasting physical activity behavior change. The study will assess the feasibility of using the Physical Activity Behavior Change(PABC) intervention for Veterans with lower limb amputation. This intervention will be delivered using wrist-worn wearable activity sensors and a home-based tablet computer to allow real-time physical activity feedback and video interface between the participants and the therapist.
详细描述
This pilot study will assess the feasibility of using the Physical Activity Behavior Change(PABC) intervention for Veterans with dysvascular lower limb amputation. In addition, preliminary efficacy of the PABC intervention will be assessed using a two-group randomized cross-over design. Testing will occur at baseline (pre-intervention), three months (end of intervention), and six months. The primary aim is to determine feasibility of using the PABC intervention with Veterans who have dysvascular amputation by measuring:
- participant retention
- dose goal attainment
- participant acceptability
- safety The secondary aim is to preliminary assess efficacy of the PABC intervention by measuring accelerometer-based physical activity and self-report disability effect sizes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lower limb amputation 1-5 years prior to enrollment
- •Type 2 Diabetes Mellitus and/or
- •Peripheral Artery Disease
- •Ambulatory using a lower limb prosthesis
- •English speaking
排除标准
- •Traumatic or cancer-related etiology of the lower limb amputation
- •Unstable heart condition, including:
- •unstable angina
- •uncontrolled cardiac dysrhythmia
- •acute myocarditis
- •acute pericarditis
- •Uncontrolled hypertension
- •Acute systemic infection
- •Decisionally challenged volunteers
- •Recent cerebral vascular accident (within two years)
- •lower extremity wound or ulcer that limits ability to ambulate
结局指标
主要结局
Retention Rate
时间窗: 3 months
Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.
Dose Goal Attainment
时间窗: 3 months
Dose goal attainment will be measured as the percent of participants in the intervention phase of the study who meet the dose goal of an average 3% increase in daily steps.
Acceptability
时间窗: 3 months
Acceptability will be measured using the mean score of the Intrinsic Motivation Inventory - Interest / Enjoyment Subscale. The scores range from 1 to 7, with higher numbers indicating higher acceptability, and a null value of 5.0.
Study-Related Adverse Events
时间窗: 3 months
Safety will be assessed as differences in rates of study-related adverse events between GROUP 1 and GROUP 2 during the first three months, when GROUP 1 is in the intervention phase and GROUP 2 is in the non-intervention control phase.
次要结局
- Accelerometer-Based Physical Activity(6 months)
- Late Life Function and Disability Scale, Frequency(6 months)
- Late Life Function and Disability Scale, Limitation(6 months)