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临床试验/NCT04414007
NCT04414007Unknown不适用

The Application of Internet+ Home-based Cardiac Rehabilitation Model in Atrial Fibrillation Patients After Radio Frequency Ablation

Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
6-minute walk test

研究概览

简要总结

Epidemiological reports show that the incidence of atrial fibrillation continues to increase. AF is the most common arrhythmia with high mortality and disability rate. Radio frequency ablation has good therapeutic effect of AF symptoms. However, even after successful radio frequency ablation, there are still many discomforts that deserve medical attention. The benefits of cardiac rehabilitation for patients with heart disease have been recognized,but the adherence with cardiac rehabilitation is not satisfactory. Home-based rehabilitation has received increasing recognition because it has overcome many obstacles for patients to participate in cardiac rehabilitation. The application of Internet+ follow-up mode and intelligent wearable devices provide new ideas for home-based cardiac rehabilitation with the progress of information technology nowadays. This study used an experimental research design. The aim was to explore the application effects of Internet platform and wearable devices in home-based cardiac rehabilitation in patients with atrial fibrillation after radio frequency ablation. The final goal is to provide the basis for the development and application of this kind of home-based cardiac rehabilitation care in patients with atrial fibrillation after radio frequency ablation.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients diagnosed with atrial fibrillation and planned for treatment with radiofrequency catheter ablation (RFA) for AF;
  • Patients with age from 18 to 75 years;
  • Patients or primary caregiver are able to use smartphones;
  • Providing oral and written informed consent.

排除标准

  • Radiofrequency ablation was not performed for various reasons;
  • patients who were unable to understand the study due to severe cognitive impairment;
  • Patients with psychiatric disorders;
  • Patients with serious and instable body or severe complications;
  • Patients sufferring other exercise contraincations.

结局指标

主要结局

6-minute walk test

时间窗: Change from Baseline 6-minute walk distance at 2 years

exercise capacity

Peak VO2

时间窗: Change from Baseline Peak VO2 at 2 years

exercise capacity

sf-36

时间窗: Change from Baseline sf-36 at 2 years

Quality of Life

次要结局

  • PSQI(Change from Baseline PSQI scores at 2 years)
  • EHRA score(Change from Baseline EHRA scores at 2 years)
  • SAS(Change from Baseline SAS scores at 2 years)
  • SDS(Change from Baseline SDS scores at 2 years)
  • AF recurrence(Change from Baseline AF recurrence at 2 years)
  • Adherence(at 2 years)

研究者

发起方
Nanjing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhipeng BAO

Principal Investigator

Nanjing Medical University

研究点 (1)

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