Schön Klinik Berchtesgadener Land
Schönau am Königssee, Bavaria, 83471, Germany
NCT Number: NCT04649918
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.
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Notify Me18 year and older
All sexes
Observational
Schönau am Königssee, Bavaria, 83471, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
COVID 19 patients perform a standardized 3-week inpatient pulmonary rehabilitation program
Time frame: Day 1 and day 21 of pulmonary rehabilitation
measure in meter
Time frame: Day 1 and day 21 of pulmonary rehabilitation
measure provided in seconds
Time frame: Day 1 and day 21 of pulmonary rehabilitation
measure provided in % predicted
Time frame: Day 1 and day 21 of pulmonary rehabilitation
measure provided in % predicted
Time frame: Day 1 and day 21 of pulmonary rehabilitation
measure provided in % predicted
Time frame: Day 1 and day 21 of pulmonary rehabilitation
score ranges from 0 to 30 with lower score indicating higher cognitive impairment
Time frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
score ranges from 0 to 100 with higher scores indicating better Quality of life
Time frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
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.
Time frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
score ranges from 0 to 21 with higher scores indicating more severe anxiety
Time frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
score ranges from 0 to 27 with higher scores indicating more severe depression
Time frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
patients will be asked if they still perceive COVID-19 related dyspnea: answer possibilities yes or no
Time frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
patients will be asked if they still perceive COVID-19 related cough: answer possibilities yes or no
Time frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
patients will be asked if they still perceive COVID-19 related cognitive impairment: answer possibilities yes or no
Time frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
patients will be asked if they still perceive COVID-19 related loss of appetite: answer possibilities yes or no
Time frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
scale from 1 (worst) to 10 (best)
Time frame: Day 1 and day 21 of pulmonary rehabilitation
in mg/l
Time frame: Day 1 and day 21 of pulmonary rehabilitation
in mg/l
Time frame: Day 1 and day 21 of pulmonary rehabilitation
in g/l
Time frame: Day 1 and day 21 of pulmonary rehabilitation
in g/dl
Time frame: Day 1 and day 21 of pulmonary rehabilitation
in pg/ml
Time frame: Day 1 and day 21 of pulmonary rehabilitation
in pg/ml
Schön Klinik Berchtesgadener Land
Other
Short and Medium-term Effects of Pulmonary Rehabilitation in Mild to Critical Post-acute COVID-19 - an Observational Trial
Acronym: STEPCO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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