A Home-based Mobile Guided Exercise-based Cardiac Rehabilitation Among Patients Undergoing Transcatheter Aortic Valve Replacement (REHAB-TAVR): a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in 6-minute Walk Distance
研究概览
简要总结
A two-parallel, evaluator-blind, single-center, randomized controlled trial was designed to assess the effectiveness of a home-based mobile guided exercise-based cardiac rehabilitation among patients undergoing Transcatheter Aortic Valve Replacement.
详细描述
The purpose of our study was to investigate the effect of home-based mobile-guided exercise-based cardiac rehabilitation on the improvement of exercise capacity among patients undergoing transcatheter aortic valve replacement. 90 subjects will be recruited and followed up for a six-minute walk distance, short physical performance battery, exercise adherence, quality of life, frailty, nutritional status, sleep status, readmission rate, and all-cause mortality et al. The subjects will be invited to participate in on-site visits at 1, 3, and 6 months. Patients in the interventional group will receive a home-based mobile-guided exercise-based cardiac rehabilitation for 3 months. The home-based mobile-guided exercise-based cardiac rehabilitation is a multi-component intervention strategy including the preparation for discharge, family support, motivational interviews, health education, telephone follow-up, wearable devices, APP, et al. While the patients in the control group will receive routine care. For example, the preparation for discharge of the control group does not include the guidance of mobile-guided exercise-based cardiac rehabilitation, family support, and motivational interviews. After discharge, nurses will conduct telephone follow-ups once a month for the control group. Baseline data and outcomes will be collected in a Case Report Form.
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
- 60 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years and ≤ 89 years old;
- •Patients scheduled to be discharged after TAVR;
- •Those who have the ability to read and write, and have normal speech and communication skills;
- •Patients and their families are willing to participate in this study;
- •Patients or family members have the ability to use mobile and an app.
排除标准
- •Serious complications occur before discharge (such as major bleeding, stroke, valve detachment, moderate or above perivalve leakage, coronary artery occlusion, etc.) ;
- •Patients who are unable to participate in postoperative exercise rehabilitation due to limb dysfunction;
- •Being in palliative care or treatment;
- •Those with other Contraindication to exercise-based cardiac rehabilitation (such as resting ECG changes indicating significant ischemia, acute myocardial infarction or other acute cardiac events, unstable angina, uncontrolled arrhythmia, heart failure decompensation, etc.);
- •Currently participating in other rehabilitation projects.
研究组 & 干预措施
The REHAB-TAVR group
For the REHAB-TAVR group, discharge preparation will involve an exercise endurance test, exercise prescription guidance, motivational interviews, instruction on telerehabilitation, and the provision of family and peer support. Following discharge, patients will be required to adhere to their personalized exercise prescription and attend scheduled onsite follow-ups after discharge. The management model employed for this group is called home-based mobile guided exercise-based cardiac rehabilitation.
干预措施: Home-based mobile guided exercise-based cardiac rehabilitation (Behavioral)
The Routine-TAVR group
Preparation for discharge will only involve an exercise endurance test and the guidance of an exercise prescription for the Routine-TAVR group. Following discharge, nurses will conduct monthly telephone follow-ups to check on the patient's progress. Additionally, patients will be scheduled for onsite follow-ups at the Outpatient Department.
干预措施: Routine Care (Behavioral)
结局指标
主要结局
Change in 6-minute Walk Distance
时间窗: Month 3
Distance walked in 6 minutes
次要结局
- Change in Short Physical Performance Battery (SPPB)(Month 3 and Month 6)
- Change in 6-minute Walk Distance(Month 6)
- Exercise Adherence Assessed by the Exercise Adherence Rating Scale (EARS)(Month1, Month 3 and Month 6)