Mobile Intervention Supervised Exercise Therapy Study 1
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of Participants Who Complete a 12-week Exercise Therapy Program
研究概览
简要总结
This is a randomized controlled trial evaluating the impact of the mobile phone delivered SVS SET Program on utilization, functional capacity, symptoms and quality of life.
详细描述
This is a national randomized controlled study with approximately 10-15 sites enrolling patients with Rutherford II peripheral artery disease (PAD) in total. Patients will be randomized between the SVS SET Program and "usual care" for each site. The primary outcome will be to study the site-specific effect on utilization of exercise therapy. Secondary outcomes will be the effect on the 6-minute-walk test, passive activity and quality of life.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of Age
- •Rutherford Class I-II PAD (claudication)
- •Ambulatory
- •Exercise Therapy Naive (>18 mo)
- •Primary Owner of an Android or iOS device
- •Willingness to participate (text, call, fill out surveys) via a mobile phone
排除标准
- •Symptomatic coronary artery disease
- •Oxygen dependent COPD
- •Significant osteoarthritis limiting ambulation
研究组 & 干预措施
SVS SET Program
Participants enroll in SVS Program which includes 1) educational information on PAD, exercise and nutrition, 2) weekly health coaching, and 3) walking therapy prescription.
干预措施: Exercise Therapy (Behavioral)
Usual Care
This usual care arm will allow sites to direct patients as they usually do. This could include an in-person exercise therapy program or simply exercise instruction during an office visit.
结局指标
主要结局
Number of Participants Who Complete a 12-week Exercise Therapy Program
时间窗: 12 weeks.
Completion of a 12-week program in the treatment group will be completion of the remote SVS SET Program while the "usual care" group may have an in-person 12-week exercise therapy program.
次要结局
- Adherence as Measured by Completion of Scheduled Daily Walks(12 weeks.)
- Mobile Phone Delivered 6-Minute Walk Test(Weeks 0, 6 and 12)
- Freedom From Intervention as Measured by Absence of Surgical Intervention at One Year(1 year.)
- Quality of Life Survey as measured by the mini-Walking Impairment Questionnaire (mini-WIQ)(Weeks 1, 6, and 12)
- Passive Activity as Measured on Mobile Device(12 weeks.)
研究者
Oliver Aalami
Clinical Associate Professor of Surgery
Stanford University