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

NCT ID: NCT04649918

Last Updated: 2021-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-25

Study Completion Date

2021-01-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19 SARS-CoV Infection Pulmonary Rehabilitation Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

mild to moderate COVID 19

patients post-acute mild to moderate COVID 19

pulmonary rehabilitation

Intervention Type OTHER

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

severe to critical COVID 19

patients post-acute severe to critical COVID 19

pulmonary rehabilitation

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pulmonary rehabilitation

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Dr. Andreas Rembert Koczulla

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andreas R Koczulla, MD

Role: PRINCIPAL_INVESTIGATOR

Philipps University Marburg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Schön Klinik Berchtesgadener Land

Schönau am Königssee, Bavaria, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COVID-Rehab

Identifier Type: -

Identifier Source: org_study_id