Efficacy and Safety of a Remote Conditioning Program in Patients Supported With a Ventricular Assist Device: THE RE-ACTION-VAD TRIAL.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 10
研究概览
简要总结
Current international guidelines recommend that patients with a heart pump (left ventricular assist device, LVAD) participate in supervised exercise cardiac rehabilitation programs. However, not all patients with a heart pump are able to attend to a supervised program on a daily basis.
The goal of this clinical trial is to determine whether a home-based exercise program helps patients with a heart pump improve their exercise capacity and quality of life, guided by telemedicine tools including a mobile app, smartwatch, and remote medical checkups. The study will also provide information about the safety of this program by monitoring for any issues or symptoms during home activity.
The trial aims to answer the following questions:
- Does a 12-week remote exercise program improve patients' exercise capacity? This will be measured using the 6-minute walk test and a cardiopulmonary exercise test.
- Is it safe for patients to follow this exercise plan at home while being monitored through a mobile app and smartwatch?
- Does the program improve quality of life and reduce feelings of anxiety or depression? This will be assessed using widely validated questionnaires, such as the Kansas City Cardiomyopathy Questionnaire.
Researchers will compare the remote exercise program to standard care, which usually does not include exercise for patients who are unable to attend the hospital daily.
Participants will:
- Join the study voluntarily after signing a consent form.
- Be randomly assigned, with a 50% chance of being in either the exercise group (following a structured plan with a mobile app) or the usual care group (receiving general written advice), to see which approach works best for recovery.
- Follow a 12-week home-based routine if in the exercise group, including warm-up routine, walking or cycling, respiratory exercises, and light strength training, all supported by the mobile app, smartwatch, and professional monitoring.
- Visit the hospital three times over six months for medical checkups, including walking and exercise tests, blood analyses, and questionnaires about physical and emotional health.
详细描述
Introduction Although cardiac rehabilitation is recommended in patients with a durable Left Ventricular Assist Device (LVAD), approximately 50% of candidates cannot attend in-person programs due to geographical dificulties.
Study Rationale and Design The RE-ACTION-VAD Trial is the first multicenter randomized controlled trial designed to evaluate the efficacy and safety of a remote conditioning exercise program in patients with recent implantation of a durable Left Ventricular Assist Device (LVAD).
A total of 78 patients will be enrolled and randomized in a 1:1 ratio to:
- Remote conditioning group: patients will undergo a three-month home-based program including aerobic, resistance, and respiratory training. Follow-up will be conducted through Telemedicine (mobile application and a smart watch); or
- Usual care group: patients will receive written general exercise recommendations.
The primary objective is to assess whether there is an improvement in the distance covered on the 6-minute walk test at 6-month follow-up. Secondary objectives include evaluation of safety, and improvements in cardiopulmonary exercise parameters, quality of life questionnaires, frailty scales, and psychological questionnaires.
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 (Outcomes Assessor)
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
- •(must meet all):
- •Recent LVAD Implantation (<6 months)
- •Clinical stability (defined as meeting all of the following criteria): discharge from the LVAD implantation hospitalization, absence of inotropic medication, hemoglobin >9 g/dL, and no active infection.
- •Inability to participate in a supervised rehabilitation program (due to lack of availability, or inability because geographical reasons).
排除标准
- •Functional Inability to Perform Cardiopulmonary Exercise Testing
- •Prior Participation in a Supervised Rehabilitation Program (after the LVAD implantation)
研究者
Mercedes Rivas-Lasarte
Cardiologist, MD, PhD
Puerta de Hierro University Hospital