Mobile Health of Lifestyle to Patients With Cardiac Electronic Implantable Device: Randomized Clinical Trial
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 exercise capacity
研究概览
简要总结
Previous studies suggested that most patients with Cardiac Electronic Implantable devices have a perception of describing the lifestyle due to a limitation of daily activities and physical exercise, besides the consequences in the psychological aspects such as anxiety and depression. The MHOL-CEID is a randomized controlled trial that Verifies the effectiveness of the Mobile Health of lifestyle that focuses on aspects of physical functional, psychosocial, and quality of life of patients with Cardiac Electronic Implantable Device.
详细描述
Cardiovascular diseases represent one of the main causes of death in the Brazilian population, as well as dysfunctions of the heart conduction system. In an attempt to treat and correct heart conduction system dysfunctions, Cardiac Electronic Implantable Device (CEID) was developed. Most people with CEID have a perception of describing the lifestyle due to a limitation of daily activities and physical exercise, besides the consequences in the psychological aspects such as anxiety and depression. These changes in the psychosocial conduct of patients with CEID are due to the lack of knowledge and the lack of effective guidance, being of fundamental importance to elaborate the resources of education in health for patients with CEID. Health promotion through educational intervention is a recognized strategy and an Internet approach to the mobile health proposal is a recognized and promising practice.
This randomized controlled study is been conducted to verify the effectiveness of the Mobile Health of lifestyle that focuses on aspects of physical functional, psychosocial, and quality of life of patients with CEID. The hypothesis is that the use of Mobile Health of lifestyle provides greater physical functional, psychological aspects, and quality of life to patients with CIED.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent prior to randomization and any study procedure;
- •Patients with any CIED
- •Access to the internet
- •Clinical stability in the last 3 weeks
- •With left ventricular ejection fraction (LVEF) greater than 40%
- •Skill to conduct the self-monitoring of intensity in physical activity
- •New York Heart Association classification 1 or 2
排除标准
- •Unstable angina
- •Uncontrolled systemic arterial hypertension
- •Cardiac arrhythmia effort- induced
- •People with a musculoskeletal or neurological problem
- •Cognitive disability
- •Patients opposed to the participation in the research
- •Other concomitants cardiovascular disease, including uncontrolled diabetes mellitus (systemic hypertension without target-organ impairment is allowed);
- •Moderate or severe chronic obstructive pulmonary disease;
结局指标
主要结局
Functional exercise capacity
时间窗: Six minutes
Six walk minutes test to assess and measures the distance that patient can walk on a flat in a period of 6 minutes
次要结局
- Quality of life of patients(Thirty minutes)
- Anxiety and depression(Thirty minutes)
- Level of physical activity(Thirty minutes)
研究者
Martino Martinelli Filho
MD, PHD
InCor Heart Institute