Short and Medium-term Effects of Pulmonary Rehabilitation in Mild to Critical Post-acute COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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Short and Medium-term Effects of Pulmonary Rehabilitation in Mild to Critical Post-acute COVID-19 - an Observational Trial

Conditions
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Covid19, SARS-CoV Infection, Pulmonary Rehabilitation, Quality of Life

Intervention / Treatment
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* Other: pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-acute phase COVID-19 patients with mild, moderate, severe or critical course written informed consent Exclusion Criteria: patients who are unable to walk

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mild to moderate COVID 19<br>patients post-acute mild to moderate COVID 19 | Other: pulmonary rehabilitation<br>* COVID 19 patients perform a standardized 3-week inpatient pulmonary rehabilitation program<br>|
| severe to critical COVID 19<br>patients post-acute severe to critical COVID 19 | Other: pulmonary rehabilitation<br>* COVID 19 patients perform a standardized 3-week inpatient pulmonary rehabilitation program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6-minute walk distance | measure in meter | Day 1 and day 21 of pulmonary rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in endurance shuttle walk distance | measure provided in seconds | Day 1 and day 21 of pulmonary rehabilitation | 
| Change in Diffusion capacity of the lungs for Carbon monoxide | measure provided in % predicted | Day 1 and day 21 of pulmonary rehabilitation | 
| Change in Forced Vital Capacity | measure provided in % predicted | Day 1 and day 21 of pulmonary rehabilitation | 
| Change in total lung capacity | measure provided in % predicted | Day 1 and day 21 of pulmonary rehabilitation | 
| change in Montreal cognitive assessment test | score ranges from 0 to 30 with lower score indicating higher cognitive impairment | Day 1 and day 21 of pulmonary rehabilitation | 
| change in short-form 36 question health survey | score ranges from 0 to 100 with higher scores indicating better Quality of life | Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation | 
| change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29) | A questionnaire designed to measure self-reported physical, mental and social health and wellbeing. Higher scores represent worse symptomatology in relation to the mean value of 50 points with a standard deviation of 10 points. | 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) | score ranges from 0 to 21 with higher scores indicating more severe anxiety | Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation | 
| Change in the scale of the patient health questionnaire - Depression (PHQ-D) | score ranges from 0 to 27 with higher scores indicating more severe depression | Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation | 
| Change in prevalence of COVID-19 related dyspnea | patients will be asked if they still perceive COVID-19 related dyspnea: answer possibilities yes or no | Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation | 
| Change in prevalence of COVID-19 related cough | patients will be asked if they still perceive COVID-19 related cough: answer possibilities yes or no | Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation | 
| Change in prevalence of COVID-19 related cognitive impairment | patients will be asked if they still perceive COVID-19 related cognitive impairment: answer possibilities yes or no | Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation | 
| Change in prevalence of COVID-19 related loss of appetite | patients will be asked if they still perceive COVID-19 related loss of appetite: answer possibilities yes or no | Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation | 
| Change in general perceived well-being | scale from 1 (worst) to 10 (best) | Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation | 
| change in D-Dimer level | in mg/l | Day 1 and day 21 of pulmonary rehabilitation | 
| change in c-reactive protein level | in mg/l | Day 1 and day 21 of pulmonary rehabilitation | 
| change in leukocytes level | in g/l | Day 1 and day 21 of pulmonary rehabilitation | 
| change in hemoglobin level | in g/dl | Day 1 and day 21 of pulmonary rehabilitation | 
| change in troponin level | in pg/ml | Day 1 and day 21 of pulmonary rehabilitation | 
| change in pro-brain natriuretic peptide level | in pg/ml | Day 1 and day 21 of pulmonary rehabilitation |