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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04649918
Other study ID # COVID-Rehab
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 25, 2020
Est. completion date January 16, 2021

Study information

Verified date December 2021
Source Schön Klinik Berchtesgadener Land
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 16, 2021
Est. primary completion date January 16, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
pulmonary rehabilitation
COVID 19 patients perform a standardized 3-week inpatient pulmonary rehabilitation program

Locations

Country Name City State
Germany Schön Klinik Berchtesgadener Land Schönau Am Königssee Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Schön Klinik Berchtesgadener Land

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in 6-minute walk distance measure in meter Day 1 and day 21 of pulmonary rehabilitation
Secondary change in endurance shuttle walk distance measure provided in seconds Day 1 and day 21 of pulmonary rehabilitation
Secondary Change in Diffusion capacity of the lungs for Carbon monoxide measure provided in % predicted Day 1 and day 21 of pulmonary rehabilitation
Secondary Change in Forced Vital Capacity measure provided in % predicted Day 1 and day 21 of pulmonary rehabilitation
Secondary Change in total lung capacity measure provided in % predicted Day 1 and day 21 of pulmonary rehabilitation
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary change in D-Dimer level in mg/l Day 1 and day 21 of pulmonary rehabilitation
Secondary change in c-reactive protein level in mg/l Day 1 and day 21 of pulmonary rehabilitation
Secondary change in leukocytes level in g/l Day 1 and day 21 of pulmonary rehabilitation
Secondary change in hemoglobin level in g/dl Day 1 and day 21 of pulmonary rehabilitation
Secondary change in troponin level in pg/ml Day 1 and day 21 of pulmonary rehabilitation
Secondary change in pro-brain natriuretic peptide level in pg/ml Day 1 and day 21 of pulmonary rehabilitation
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