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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Covid19; Pulmonary Rehabilitation; SARS-CoV Infection
• Intervention / Treatment: Other: pulmonary rehabilitation

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Schönau Am Königssee, Bavaria, Germany, 83471
      • Schön Klinik Berchtesgadener Land

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mild to moderate COVID 19; patients post-acute mild to moderate COVID 19	Other: pulmonary rehabilitation; 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	Other: pulmonary rehabilitation; COVID 19 patients perform a standardized 3-week inpatient pulmonary rehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6-minute walk distance	measure in meter	Day 1 and day 21 of pulmonary rehabilitation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Schön Klinik Berchtesgadener Land
• Investigators: Principal Investigator: Andreas R Koczulla, MD, Philipps University Marburg Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Actual): January 16, 2021
• Study Completion (Actual): January 16, 2021

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19
• Other Study ID Numbers: COVID-REHAB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No