Effects of Home-based Exercise Rehabilitation on Healthcare Utilization in HeartMate 3TM Patients: A Randomized Controlled Pilot Study (MOVE-LVAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Mean number of clinic visits
研究概览
简要总结
To demonstrate that home-based exercise rehabilitation (HER) compared to usual care (UC) results in a significant reduction in healthcare utilization in HeartMate 3 (HM3) left ventricular assist device (LVAD) patients.(defined as rehospitalization, VAD Clinic visits, and ER visits during the 1st year after index discharge following LVAD implantation).
详细描述
HER Subjects:
Get Garmin activity watch (has its own smartphone app to be activated)*, Datos app Get resistance bands and light weights Exercise prescription: Initially by physical therapist prior to discharge home & updated every month.
UC Subjects:
Get Garmin activity watch (has its own smartphone app to be activated), Datos app Exercise prescription: Try to get to 30 min of exercise 5 days a week
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
- 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 on the date of randomization
- •Patient implanted with a new HeartMate 3 LVAD at URMC
- •Patients enrolling in the study at the time of index discharge home following new HM3 LVAD implantation will be evaluated by a HF cardiologist and physical therapist and will need to demonstrate ability to ambulate independently. Patients enrolling in the study after their index discharge home following HM3 LVAD implantation will be evaluated by a HF cardiologist or VAD Coordinator and will need to demonstrate ability to ambulate independently.
- •Patient willing to participate in HER.
- •Patient owns a smartphone with Internet connection.
排除标准
- •Major comorbidities or limitations that may interfere with exercise training (including significant orthopedic/neurologic limitations, decompensated HF, uncontrolled arrhythmias, unstable angina).
- •Patient with a life expectancy <12 months.
- •Patient unwilling to sign the consent for participation.
- •Patient unwilling or unable to cooperate with the study protocol
- •Patient who does not anticipate being a resident of the area for the scheduled duration of the research study
- •Pregnancy
结局指标
主要结局
Mean number of clinic visits
时间窗: 1 year
Healthcare utilization will be measured as the sum of all-cause rehospitalizations, outpatient VAD Clinic visits and emergency room visits room visits
次要结局
- Mean change in number of participants with improved quality of life(baseline to 1 year)
- Mean change in the number of daily steps taken(1 year)
- Mean change 6-minute walk distance(baseline to 1 year)
- Mean number of days out of the hospital(1 year)
研究者
Himabindu Vidula
Associate Professor
University of Rochester