Short and Medium-term Effects of Pulmonary Rehabilitation in Mild to Critical Post-acute COVID-19 - an Observational Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in 6-minute walk distance
研究概览
简要总结
As a direct consequence of the COVID-19 pandemic, it is assumed that the number of patients with COVID-19-related disabilities will increase significantly. Patients with mild, severe, and critical forms of the disease show long-term sequelae in different systems (respiratory, muscular, psychological, cognitive etc.).
Persistent dyspnea is a frequently described symptom after the acute phase of the disease. Coupled with reduced oxygen saturation, an increased risk of developing lung fibrosis has been observed. Specialized rehabilitation medicine (e.g. pulmonary rehabilitation) might counteract these long-term consequences and therefore seems to be a promising approach to treat long-term COVID-19 consequences.
Further, there is scarce evidence about COVID-19 specific rehabilitation contents. It was suggested to use treatment regimes in analogy to patients with idiopathic pulmonary fibrosis.
There is evidence that pulmonary rehabilitation improves physical performance, quality of life and reduces anxiety and depression symptoms in patients with idiopathic pulmonary fibrosis and other chronic respiratory diseases.
Since impairments related to idiopathic pulmonary fibrosis also play an important role in COVID-19, the aim of this study is to evaluate the short and medium-term effects of a standardized 3-week pulmonary rehabilitation program. The results will be analyzed within the two cohorts (mild/moderate and severe/critical COVID 19) as well as between the two cohorts for the primary outcome. Furthermore, the effects of pulmonary rehabilitation will be compared with a retrospective cohort of idiopathic pulmonary fibrosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Post-acute phase COVID-19 patients with mild, moderate, severe or critical course
- •written informed consent
排除标准
- •patients who are unable to walk
结局指标
主要结局
Change in 6-minute walk distance
时间窗: Day 1 and day 21 of pulmonary rehabilitation
measure in meter
次要结局
- change in Montreal cognitive assessment test(Day 1 and day 21 of pulmonary rehabilitation)
- Change in prevalence of COVID-19 related loss of appetite(Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation)
- change in leukocytes level(Day 1 and day 21 of pulmonary rehabilitation)
- Change in Forced Vital Capacity(Day 1 and day 21 of pulmonary rehabilitation)
- change in short-form 36 question health survey(Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation)
- Change in the scale of general anxiety disorder - 7 questionnaire (GAD-7)(Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation)
- change in pro-brain natriuretic peptide level(Day 1 and day 21 of pulmonary rehabilitation)
- Change in Diffusion capacity of the lungs for Carbon monoxide(Day 1 and day 21 of pulmonary rehabilitation)
- Change in prevalence of COVID-19 related dyspnea(Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation)
- Change in prevalence of COVID-19 related cognitive impairment(Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation)
- change in D-Dimer level(Day 1 and day 21 of pulmonary rehabilitation)
- change in c-reactive protein level(Day 1 and day 21 of pulmonary rehabilitation)
- Change in total lung capacity(Day 1 and day 21 of pulmonary rehabilitation)
- Change in the scale of the patient health questionnaire - Depression (PHQ-D)(Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation)
- Change in general perceived well-being(Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation)
- change in troponin level(Day 1 and day 21 of pulmonary rehabilitation)
- change in endurance shuttle walk distance(Day 1 and day 21 of pulmonary rehabilitation)
- change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)(Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation)
- Change in prevalence of COVID-19 related cough(Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation)
- change in hemoglobin level(Day 1 and day 21 of pulmonary rehabilitation)
研究者
Prof. Dr. Andreas Rembert Koczulla
Professor
Schön Klinik Berchtesgadener Land