Short and Medium-term Effects of Pulmonary Rehabilitation in Mild to Critical Post-acute COVID-19
- Conditions
- Quality of LifeSARS-CoV InfectionCovid19Pulmonary Rehabilitation
- Interventions
- Other: pulmonary rehabilitation
- Registration Number
- NCT04649918
- Lead Sponsor
- Schön Klinik Berchtesgadener Land
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Post-acute phase COVID-19 patients with mild, moderate, severe or critical course
- written informed consent
- patients who are unable to walk
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description mild to moderate COVID 19 pulmonary rehabilitation patients post-acute mild to moderate COVID 19 severe to critical COVID 19 pulmonary rehabilitation patients post-acute severe to critical COVID 19
- Primary Outcome Measures
Name Time Method Change in 6-minute walk distance Day 1 and day 21 of pulmonary rehabilitation measure in meter
- Secondary Outcome Measures
Name Time Method change in Montreal cognitive assessment test Day 1 and day 21 of pulmonary rehabilitation score ranges from 0 to 30 with lower score indicating higher cognitive impairment
Change in prevalence of COVID-19 related loss of appetite 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
change in leukocytes level Day 1 and day 21 of pulmonary rehabilitation in g/l
Change in Forced Vital Capacity Day 1 and day 21 of pulmonary rehabilitation measure provided in % predicted
change in short-form 36 question health survey 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
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 score ranges from 0 to 21 with higher scores indicating more severe anxiety
change in pro-brain natriuretic peptide level Day 1 and day 21 of pulmonary rehabilitation in pg/ml
Change in Diffusion capacity of the lungs for Carbon monoxide Day 1 and day 21 of pulmonary rehabilitation measure provided in % predicted
Change in prevalence of COVID-19 related dyspnea 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
Change in prevalence of COVID-19 related cognitive impairment 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
change in D-Dimer level Day 1 and day 21 of pulmonary rehabilitation in mg/l
change in c-reactive protein level Day 1 and day 21 of pulmonary rehabilitation in mg/l
Change in total lung capacity Day 1 and day 21 of pulmonary rehabilitation measure provided in % predicted
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 score ranges from 0 to 27 with higher scores indicating more severe depression
Change in general perceived well-being Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation scale from 1 (worst) to 10 (best)
change in troponin level Day 1 and day 21 of pulmonary rehabilitation in pg/ml
change in endurance shuttle walk distance Day 1 and day 21 of pulmonary rehabilitation measure provided in seconds
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 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.
Change in prevalence of COVID-19 related cough 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
change in hemoglobin level Day 1 and day 21 of pulmonary rehabilitation in g/dl
Trial Locations
- Locations (1)
Schön Klinik Berchtesgadener Land
🇩🇪Schönau Am Königssee, Bavaria, Germany