An observational study in Covid19, SARS-CoV Infection and Pulmonary Rehabilitation, sponsored by Schön Klinik Berchtesgadener Land. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-23.
Sponsored by Schön Klinik Berchtesgadener Land · Observational
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 50 is below the median of 260 across 3,135 observational studies indexed under COVID-19.
Browse COVID-19 studies →Schön Klinik Berchtesgadener Land is the lead sponsor of 51 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients referred for an inpatient pulmonary rehabilitation program at the reference center will be recruited
Exclusion Criteria:
patients post-acute mild to moderate COVID 19
Other: pulmonary rehabilitation
patients post-acute severe to critical COVID 19
Other: pulmonary rehabilitation
COVID 19 patients perform a standardized 3-week inpatient pulmonary rehabilitation program
Change in 6-minute walk distance
measure in meter
Time frame: Day 1 and day 21 of pulmonary rehabilitation
change in endurance shuttle walk distance
measure provided in seconds
Time frame: Day 1 and day 21 of pulmonary rehabilitation
Change in Diffusion capacity of the lungs for Carbon monoxide
measure provided in % predicted
Time frame: Day 1 and day 21 of pulmonary rehabilitation
Change in Forced Vital Capacity
measure provided in % predicted
Time frame: Day 1 and day 21 of pulmonary rehabilitation
Change in total lung capacity
measure provided in % predicted
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
change in D-Dimer level
in mg/l
Time frame: Day 1 and day 21 of pulmonary rehabilitation
change in c-reactive protein level
in mg/l
Time frame: Day 1 and day 21 of pulmonary rehabilitation
change in leukocytes level
in g/l
Time frame: Day 1 and day 21 of pulmonary rehabilitation
change in hemoglobin level
in g/dl
Time frame: Day 1 and day 21 of pulmonary rehabilitation
change in troponin level
in pg/ml
Time frame: Day 1 and day 21 of pulmonary rehabilitation
change in pro-brain natriuretic peptide level
in pg/ml
Time frame: Day 1 and day 21 of pulmonary rehabilitation
Plan to share: Undecided
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Schön Klinik Berchtesgadener Land