NCT04649918: STEPCO

Short and Medium-term Effects of Pulmonary Rehabilitation in Mild to Critical Post-acute COVID-19

Completed Last updated 23 December 2021

What this trial tests

trial testing pulmonary rehabilitation in Covid19 in 50 participants. Completed in 16 January 2021.

Timeline

25 November 2020

Primary endpoint
16 January 2021

16 January 2021

Quick facts

Lead sponsor	Schön Klinik Berchtesgadener Land
Status	Completed
Study type	OBSERVATIONAL
Enrollment	50
Start date	25 November 2020
Primary completion	16 January 2021
Estimated completion	16 January 2021
Sites	1 location across Germany

Drugs / interventions tested

• pulmonary rehabilitation

Conditions studied

• Covid19 — all drugs for Covid19 →
• SARS-CoV Infection — all drugs for SARS-CoV Infection →
• Pulmonary Rehabilitation — all drugs for Pulmonary Rehabilitation →
• Quality of Life — all drugs for Quality of Life →

Sponsor

Schön Klinik Berchtesgadener Land

Who can join

18 and older, any sex, with Covid19 or SARS-CoV Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Post-acute COVID-19 syndrome.
   Nalbandian A, Sehgal K, Gupta A, Madhavan MV, et al · · 2021 · cited 3355× · PMID 33753937 · DOI 10.1038/s41591-021-01283-z
2. Outpatient Pulmonary Rehabilitation in Patients with Long COVID Improves Exercise Capacity, Functional Status, Dyspnea, Fatigue, and Quality of Life.
   Nopp S, Moik F, Klok FA, Gattinger D, et al · · 2022 · cited 182× · PMID 35203084 · DOI 10.1159/000522118
3. Benefits of pulmonary rehabilitation in COVID-19: a prospective observational cohort study.
   Gloeckl R, Leitl D, Jarosch I, Schneeberger T, et al · · 2021 · cited 139× · PMID 34095290 · DOI 10.1183/23120541.00108-2021