Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center Versus Traditional Hospital Model
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Functional capacity
研究概览
简要总结
The aim of this study is to establish an innovative Cardiac Tele-Rehabilitation (CTR) model. It could expands assistance resources through coordination with public administrations, developing a physical exercise program (PEP) assistance model in phase II that resolves the current situation of lack of adherence in the PEP due in part to the long waiting time to start it. To sum up this study could improve adherence in Cardiac Rehabilitation Phase III. It represents an opportunity to validate an innovative model for the realization of the PEP for phase II that could be expanded to other centres.
详细描述
Cardiac Rehabilitation (CR) programs show benefits in cardiovascular morbidity and mortality, exercise capacity, risk factors and quality of life. The use of new information and communication technologies (ICT) allows remote monitoring of activity and rhythm, defining a new model of cardiac tele-rehabilitation (CTR) and proving to be safe.
The investigators intend to evaluate a new model of CR in Phase II in acute coronary syndrome (ACS), based on the implementation of the physical exercise program (PEP) in a public sports centre (PSC) with tele-monitoring by means of a wearable electronic device, S-PATCH3-Cardio, to compare the adherence of a PEP based on a CTR-PSC model with the traditional in-hospital program (PEP-H) maintaining the efficacy and safety of the CR program.
Patients with recent stratified ACS of low and / or moderate risk will be included who will be randomly assigned to the PEP-H group who will perform 18 PEP sessions with strength training and cardiorespiratory resistance in a hospital, or a CTR-PSC group that performs the 18 sessions of the PEP with strength training and cardiorespiratory resistance in the PSC.
All patients will perform the rest of the CR program at the hospital that it includes: functional tests, consultations with nurse, cardiologist, rehabilitation doctor, and the educational program, with 10 Workshops in a Cardio-healthy Classroom.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Recent ACS (1-12 months) of low / moderate risk for the realization of a PEP and without physical impediments for it
- •Availability of a mobile phone with Android operating system where you can install the S-PATCH3-Cardio application
- •Patients who recognize that they are trained to operate the S-PATCH3-Cardio device after being instructed in its operation and perform a 24-hour simulation.
- •Signature of informed consent
排除标准
- •Baseline ergospirometry that does not reach maximalist criteria (respiratory quotient> 1.1)
- •Mental disability
- •Associated comorbidity that prevents performing PEP
研究组 & 干预措施
PEP-H
Physical exercise program at a hospital
干预措施: Cardiac Rehabilitation (Procedure)
PEP-PSC
Physical exercise program with tele-monitoring in a public sport centre
干预措施: Cardiac Rehabilitation (Procedure)
结局指标
主要结局
Functional capacity
时间窗: At the end of the program (6 weeks)
Change of functional capacity measured by cardiopulmonary exercise test
Adherence to physical exercise
时间窗: At the end of the program (6 weeks)
Adherence to physical exercise measured by number of physical exercise sessions realized by each patient
次要结局
- Abdominal perimeter(At the end of the program (6 weeks))
- Blood pressure levels(At the end of the program (6 weeks))
- Weight(At the end of the program (6 weeks))
- Adherence to Mediterranean Diet(At the end of the program (6 weeks))
- Glycated hemoglobin levels (HbA1c)(At the end of the program (6 weeks))
- Glucose levels(At the end of the program (6 weeks))
- Low-density lipoprotein (LDL) levels(At the end of the program (6 weeks))
- Body Mass Index (BMI)(At the end of the program (6 weeks))
- High-density lipoprotein (HDL) levels(At the end of the program (6 weeks))
- Total colesterol levels(At the end of the program (6 weeks))
- Smoking(At the end of the program (6 weeks))
- Phisical exercise profile(At the end of the program (6 weeks))
研究者
Juan Izquierdo García
Juan Izquierdo García, Physical Therapist, Principal Investigator
Hospital Universitario 12 de Octubre