Use of mHealth to Increase Physical Activity for Patients Recently Hospitalized With Acute Heart Failure: 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
- 116
- 试验地点
- 1
- 主要终点
- Change in 6-minute walking distance (6MWD)
研究概览
简要总结
The aim of this trial is to determine if a mobile application that promotes physical exercise in the follow-up of patients recently hospitalized with acute heart failure can improve exercise capacity after 6 months and physical activity levels compared to the standard follow-up.
A randomized clinical trial will be conducted with 100 consecutive patients aged +18 years, hospitalized for acute decompensated heart failure in a tertiary referral hospital who own a mobile phone compatible with MyPlan and access to Wi-Fi or mobile data. At discharge, patients will be randomly assigned in two groups; the intervention group will be followed with a smartphone application to promote physical activity, whereas the control group will take responsibility in their adherence to exercise recommendations. Main study variables will be functional capacity after 6 months, which will be evaluated using the six minute walking test, and physical activity levels, using the International Physical Activity Questionnaire (IPAQ). The study will be analyzed using the intention-to-treat principle. The project has been authorized by the local committee for ethics in clinical research.
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
- 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
- •Aged +18 years
- •Hospitalized for acute decompensated heart failure in a tertiary referral hospital
- •Owning a mobile phone compatible with MyPlan and access to Wi-Fi or mobile data (either the patient or the caregiver)
排除标准
- •NYHA IV patients
- •Currently listed for heart transplant
- •Left ventricular assist device recipient
- •Ventricular arrhythmia within prior 6 months
- •Uncontrolled arterial hypertension or resting heart rate >100 bpm
- •Acute myocarditis or pericarditis
- •Severe aortic stenosis
- •Hypertrophic obstructive cardiomyopathy
- •Advanced AV block
- •Muscle-skeletal or neurologic disease preventing to perform study procedures
- •ACS within prior month
- •Severe lung disease
- •Moderate or severe cognitive impairment
- •Unable/unwilling to consent
- •Projected life expectancy <6 months
- •Clinical judgment concerning other safety issues
结局指标
主要结局
Change in 6-minute walking distance (6MWD)
时间窗: 6 months
次要结局
- Participant reported physical activity levels, using the International Physical Activity Questionnaire (IPAQ)(6 months)
