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临床试验/NCT04848298
NCT04848298已完成不适用

Use of mHealth to Increase Physical Activity for Patients Recently Hospitalized With Acute Heart Failure: a Randomized Clinical Trial

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2021年4月22日最近更新:
适应症

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

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)

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (1)

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