A Pilot Trial of Prehabilitation Among Patients Undergoing PAD Revascularization
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Feasibility of Study as Indicated by Number of Participants
研究概览
简要总结
Patients undergoing elective revascularization of their peripheral artery disease will be randomized to a prehabilitation program or usual care prior to their scheduled procedure.
详细描述
Patients undergoing elective revascularization for their peripheral artery disease will be randomized to a "prehabilitation" program prior to their surgery or to usual care. The prehabilitation program is self-directed program designed to improve health and quality of life prior to surgery. The program is currently offered to general surgery patients; this study will examine the feasibility and acceptability of such a program in a different patient population.
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 (Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented lower extremity PAD
- •Ability to walk at least 1 block
- •Sedentary
- •Medical clearance from the surgical team
- •Competent to provide consent
排除标准
- •Life expectancy < 6 months
- •Co-morbidities which limit walking to a severe degree
- •Signs of critical limb ischemia
- •Recent or current enrollment in a formal exercise program
- •Recent cardiovascular events including stroke, TIA, severe valve disease, etc.
- •Current substance abuse
- •Psychiatric disorder which limits ability to participate in study procedures
- •Non-English speaking
研究组 & 干预措施
Prehabilitation
Participants will be referred to the Michigan Surgical & Health Optimization Program in the month leading up to their surgery. Individuals are encouraged to increase their physical activity, practice stress reduction, and other behaviors associated with good health
干预措施: Prehabilitation (Behavioral)
Usual Care
Participants will follow the pre-operative instructions provided by their surgical team.
结局指标
主要结局
Feasibility of Study as Indicated by Number of Participants
时间窗: 1 day
The feasibility of the study will be assessed by analyzing the recruitment of subjects to the study and the compliance of recruited subjects to the protocol. Feasibility will be defined as able to screening, approaching, and enrolling 25 eligible patients to the pilot study.
Acceptability of Study as Indicated by Percentage of Participation
时间窗: 8 months
The willingness of patients to enroll and complete the basic study procedures. Acceptability will be defined as low drop out-rates (\<15%), completion of quality of life surveys, and \>85% usage of the pedometers.
次要结局
- Increased Physical Activity Characteristics(8 months)
- Health-related Quality of Life(8 months)
研究者
Elizabeth A. Jackson
Associate Professor of Internal Medicine
University of Michigan