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临床试验/NCT06291922
NCT06291922招募中不适用

Home-Based Exercise Program Using Mobile Technology After Left Ventricular Assist Device Implantation

University of Pennsylvania8 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年8月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
8
主要终点
Effects of exercise intervention on physical activity and capacity (distance)

研究概览

简要总结

The goal of this clinical trial is to evaluate the effects of a home-based exercise program using mobile technology on physical activity and capacity, frailty and muscle mass, and quality of life in patients with a newly implanted HeartMate 3 left ventricular assist device (HM3 LVAD). Researchers will compare the effects of an exercise intervention vs. usual care on physical activity and capacity, frailty and muscle mass, and quality of life.

详细描述

Eligible subjects who sign the consent form will be randomized to either the exercise intervention arm or the usual care arm. As part of the baseline assessment, all subjects will measure their average daily steps during week 1 using a Garmin activity tracking watch, complete a six-minute walk test, complete frailty testing (including measurements of handgrip strength and gait speed), and complete surveys. Subjects will also complete a CT scan to evaluate muscle mass. After completing baseline assessments, subjects will be randomized to one of the study arms.

Subjects in the usual care arm will receive a Garmin activity tracking watch to wear continuously. Subjects will receive reminders from a smartphone app (Datos) to wear the watch. Subjects will be encouraged to increase daily walking as tolerated. In addition to standard of care clinic visits, they will receive phone calls from the study research coordinator reminding them to wear the watch and to walk.

Subjects in the exercise intervention arm will first have an initial training session with an interventionist to review exercises and safe practices. Subjects will receive an individualized exercise prescription for frequency, duration, and intensity of walking and strengthening exercises (including use of resistance bands and light weights). Subjects' progress in the exercise program will be remotely monitored using the activity tracking watch and the smartphone app, and subjects will complete questionnaires through the app. Subjects will complete video calls with the interventionist throughout the duration of the study and will receive updated personalized exercise prescriptions based on their progress.

Subjects in both study arms will have regular follow up VAD Clinic appointments per standard of care practices. Subjects will complete questionnaires, complete six-minute walk testing, complete frailty testing (including measurements of handgrip strength and gait speed), and undergo a chest CT scan without contrast as part of follow up activities. Throughout the study, data will be collected from the medical record.

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
  • •Newly implanted with a HeartMate 3™ LVAD for the first time
  • •Able to ambulate independently (with or without the use of an assistive device)
  • •Owns a smartphone with Internet connection
  • •Patient will be discharged home with LVAD or patient will be living at home with LVAD within 45 days of index discharge

排除标准

  • •1. Major comorbidities or limitations that may interfere with exercise training (including significant orthopedic/neurologic limitations, decompensated heart failure, uncontrolled arrhythmias, unstable angina)

研究组 & 干预措施

Exercise Intervention

Experimental

The exercise intervention focuses on walking and strengthening exercises with a standardized protocol to guide exercise prescription and exercise progression based on data obtained from the activity tracking watch and smartphone app.

干预措施: Exercise Intervention (Behavioral)

Usual Care

Other

The usual care group will be encouraged to increase daily walking activity as they tolerate, while complying with any activity restrictions from their clinical team. The Physical Activity Guidelines for Americans recommend increasing daily walking activity as tolerated to an average of 30 minutes daily, 5 times a week.

干预措施: Usual Care (Behavioral)

结局指标

主要结局

Effects of exercise intervention on physical activity and capacity (distance)

时间窗: 6 months

The investigators will compare the effects of the exercise intervention vs. usual care on physical activity and capacity measured by six-minute walk test distance.

Effects of exercise intervention on physical activity and capacity (step count)

时间窗: 6 months

The investigators will compare the effects of the exercise intervention vs. usual care on physical activity and capacity measured by daily steps captured by an activity tracking watch.

次要结局

  • Effects of exercise intervention on frailty and muscle mass (muscle quantity)(6 months)
  • Cost-effectiveness of the exercise intervention vs. usual care(6 months)
  • Effects of exercise intervention on frailty and muscle mass (frailty status)(6 months)
  • Effects of exercise intervention on quality of life(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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