Effectiveness of Cardiac Rehabilitation With Remote Connection Device for Patients After Surgery for Acquired Heart Valve Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Maximal oxygen uptake
研究概览
简要总结
The goal of this clinical trial is to learn if home-based cardiac rehabilitation using remote monitoring devices improves exercise capacity in patients after surgery for acquired heart valve diseases. It also aims to learn about factors affecting the outcomes of remote treatment.
The main questions it seeks to answer are:
- How does cardiac rehabilitation using remote monitoring devices improve exercise capacity in participants compared to those undergoing rehabilitation at medical facilities?
- What factors influence the outcomes of participants undergoing cardiac rehabilitation with remote monitoring devices? The researchers compare the exercise capacity of the intervention group - receiving home-based cardiac rehabilitation using remote monitoring devices - with that of the control group receiving treatment at a rehabilitation facility during the recovery phase.
All patients participating in the study receive inpatient cardiac rehabilitation during the acute phase (1 week) and the early recovery phase (1 week) at the hospital.
The control group continues supervised outpatient rehabilitation at the hospital, three sessions per week for the following month.
The intervention group undergoes home-based rehabilitation under the guidance of a therapist via the Open TeleRehab platform and self-monitors hemodynamic parameters using a personal blood pressure monitor and a handheld pulse oximeter.
Both groups are assessed for exercise capacity at baseline (pre-surgery), after each phase of rehabilitation, and one month after hospital discharge.
详细描述
This is a prospective, randomized, controlled, single-blind interventional study. We conduct the study on patients aged 18 years and older diagnosed with acquired heart valve diseases who have an indication for valve repair or replacement surgery at the Cardiovascular Center - Hanoi Medical University Hospital.
All patients participating in the study receive inpatient cardiac rehabilitation during the acute phase (1 week) and early recovery phase (1 week) at the hospital.
Before discharge, patients are randomly assigned by dice rolling into the intervention or control group, with a minimum of 22 patients in each group.
The control group continues supervised outpatient rehabilitation at the hospital, three sessions per week for the following month.
The intervention group undergoes home-based rehabilitation and self-monitors their hemodynamic parameters using a personal blood pressure monitor and a handheld pulse oximeter. Before and after each training session, patients send images of their vital signs (heart rate, blood pressure, SpO₂) to the physician via the Open TeleRehab platform. The physician immediately provides feedback if adjustments to the exercise session (intensity, duration, type) are necessary.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing first-time surgery for acquired heart valve diseases (valve replacement or repair), including the aortic valve, mitral valve, tricuspid valve, pulmonary valve, or a combination of these valves.
- •Willing to participate in the study.
排除标准
- •Contraindications to cardiac rehabilitation.
- •Patients who die during the study after hospital discharge.
结局指标
主要结局
Maximal oxygen uptake
时间窗: At the beginning of the early recovery phase (typically around 10 days after surgery), at the end of the early rehabilitation phase (immediately before hospital discharge), and one month later
Maximal oxygen uptake (VO₂ max) refers to the maximum amount of oxygen that an individual can utilize during intense or maximal exercise. And it is a gold standard indicator of cardiovascular and respiratory system efficiency. VO₂ max is typically measured using cardiopulmonary exercise testing (CPET). Higher VO₂ max values are associated with better cardiovascular health, lower risk of heart disease, and greater endurance.
Six-Minute Walk Test
时间窗: pre-operation, at the beginning of the early recovery phase, at the end of the early rehabilitation phase, and one month later
Six-Minute Walk Test (6MWT) is used widely due to its simplicity and reproducibility, delivering a consolidated image of the cardiopulmonary and musculoskeletal response to exercise. This test accurately measures the maximum distance a person can walk in 6 minutes. It requires only simple, commonly available equipment such as a pulse oximeter, a portable oxygen device (to be used if needed by the patient), a chair, a validated dyspnea scale (e.g., the Borg scale), and a stopwatch. However, the study cannot identify the cause of dyspnea, or hypoxemia, or the mechanisms underlying a particular patient's exercise intolerance. Because of this, we conduct both 6MWT and Cardiopulmonary Exercise Testing (CPET) on this research. Among healthy individuals, the average 6MWT is between 400 and 700 meters.
次要结局
- Two-minute Step Test(pre-operation, at the beginning of the early recovery phase, at the end of the early rehabilitation phase, and one month later)