The Cardiopulmonary Function Outcome and the Effect of Two Modules of Home-based Rehabilitation Programs in Patients After COVID-19 Infection - A Randomized and Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change of 6-minute walking test (6MWT) and exercise capacity
研究概览
简要总结
To follow up the cardiopulmonary function after coronavirus disease 2019 (CoVID-19) infection and compare the effect of a 12-week home-based cardiopulmonary with or without add-on remote rehabilitation on the cardiopulmonary function, emotion and quality of outcome.
详细描述
The investigators will recruit the patients post-CoVID infection for a cardiopulmonary function evaluation and a home-based rehabilitation program. The investigators hypothesize that an add-on remote rehabilitation on a home-based rehabilitation has a better effect than a home-based rehabilitation alone on the compliance rate for the exercise, and also a better outcome in terms of cardiopulmonary function testing, 6-minute walking test, physical activities and quality of life, as well as less dyspnea, depression and anxiety.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 20 years of age.
- •COVID-19 survivor after de-isolation at post-acute stage about to be discharged or already at outpatient follow-up who still have symptoms or exercise intolerance.
排除标准
- •Unable to cooperate with rehabilitation or evaluation.
- •Dependent in basic activities of living before infection (Premorbid Barthel index <80).
- •End stage patient, with life expectancy less than 1 year.
- •Having contraindications for exercise according to the evaluation of a physician.
研究组 & 干预措施
Add-on telerehabilitation combined with usual home-based rehabilitation
Add-on telerehabilitation combined with usual home-based rehabilitation
干预措施: Add-on telerehabilitation and home-based rehabilitation (Behavioral)
Stand-alone usual home-based rehabilitation
Stand-alone usual home-based rehabilitation
干预措施: Home-based rehabilitation alone (Behavioral)
Usual care
Usual care
结局指标
主要结局
Change of 6-minute walking test (6MWT) and exercise capacity
时间窗: The change in 6MWT and peak oxygen uptake will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
The distance of a 6-minute walking test and peak oxygen uptake according to cardiopulmonary exercise test will be assessed before intervention (12-week rehabilitation course), 12 weeks, 6 months and 12 months after intervention.
次要结局
- Fatigue(The change in BFI will be measured at baseline, 12 weeks, 6 and 12 months after intervention.)
- Cognitive evaluation(The change in MoCA will be measured at baseline, 12 weeks, 6 and 12 months after intervention.)
- Dyspnea scale(The change in mMRC will be measured at baseline, 12 weeks, 6 and 12 months after intervention.)
- Depression and anxiety(The change in PHQ-9 and GAD-7 will be measured at baseline, 12 weeks, 6 and 12 months after intervention.)
- Quality of life evaluation(The change in EQ-5D will be measured at baseline, 12 weeks, 6 and 12 months after intervention.)
- Grip strength(The change in grip strength will be measured at baseline, 12 weeks, 6 and 12 months after intervention.)