Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT04649918
Status:
COMPLETED
Last Update Posted:
2021-12-23
First Post:
2020-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short and Medium-term Effects of Pulmonary Rehabilitation in Mild to Critical Post-acute COVID-19
Sponsor:
Schön Klinik Berchtesgadener Land
Organization:
Study Overview
Official Title:
Short and Medium-term Effects of Pulmonary Rehabilitation in Mild to Critical Post-acute COVID-19 - an Observational Trial
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEPCO
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: