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

NCT04649918 | Completed

• 1 other identifier: COVID-Rehab
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; SARS-CoV Infection; Pulmonary Rehabilitation; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in 6-minute walk distance

  measure in meter

  Day 1 and day 21 of pulmonary rehabilitation

Secondary Outcomes (20)

• change in endurance shuttle walk distance

  Day 1 and day 21 of pulmonary rehabilitation

• Change in Diffusion capacity of the lungs for Carbon monoxide

  Day 1 and day 21 of pulmonary rehabilitation

• Change in Forced Vital Capacity

  Day 1 and day 21 of pulmonary rehabilitation

• Change in total lung capacity

  Day 1 and day 21 of pulmonary rehabilitation

• change in Montreal cognitive assessment test

  Day 1 and day 21 of pulmonary rehabilitation

Study Arms (2)

mild to moderate COVID 19

patients post-acute mild to moderate COVID 19

Other: pulmonary rehabilitation

severe to critical COVID 19

patients post-acute severe to critical COVID 19

Other: pulmonary rehabilitation

Interventions

pulmonary rehabilitation OTHER

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

mild to moderate COVID 19; severe to critical COVID 19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients referred for an inpatient pulmonary rehabilitation program at the reference center will be recruited

You may qualify if:

• Post-acute phase COVID-19 patients with mild, moderate, severe or critical course
• written informed consent

You may not qualify if:

• patients who are unable to walk

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead

Study Sites (1)

Schön Klinik Berchtesgadener Land

Schönau am Königssee, Bavaria, 83471, Germany

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Andreas R Koczulla, MD

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 2, 2020
• Study Start: November 25, 2020
• Primary Completion: January 16, 2021
• Study Completion: January 16, 2021
• Last Updated: December 23, 2021

Record last verified: 2021-12

Locations

DE (1)