Clinical trial NCT04649918: Short and Medium-term Effects of Pulmonary Rehabilitation in Mild to Critical Post-acute COVID-19
Official title: Short and Medium-term Effects of Pulmonary Rehabilitation in Mild to Critical Post-acute COVID-19 - an Observational Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
SARS-CoV Infection
Pulmonary Rehabilitation
Quality of Life
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients referred for an inpatient pulmonary rehabilitation program at the reference center will be recruited

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in 6-minute walk distance
timeFrame: Day 1 and day 21 of pulmonary rehabilitation
Secondary outcomes:
measure: change in endurance shuttle walk distance
timeFrame: Day 1 and day 21 of pulmonary rehabilitation
measure: Change in Diffusion capacity of the lungs for Carbon monoxide
timeFrame: Day 1 and day 21 of pulmonary rehabilitation
measure: Change in Forced Vital Capacity
timeFrame: Day 1 and day 21 of pulmonary rehabilitation
measure: Change in total lung capacity
timeFrame: Day 1 and day 21 of pulmonary rehabilitation
measure: change in Montreal cognitive assessment test
timeFrame: Day 1 and day 21 of pulmonary rehabilitation
measure: change in short-form 36 question health survey
timeFrame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
measure: change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)
timeFrame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
measure: Change in the scale of general anxiety disorder - 7 questionnaire (GAD-7)
timeFrame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
measure: Change in the scale of the patient health questionnaire - Depression (PHQ-D)
timeFrame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
measure: Change in prevalence of COVID-19 related dyspnea
timeFrame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
measure: Change in prevalence of COVID-19 related cough
timeFrame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
measure: Change in prevalence of COVID-19 related cognitive impairment
timeFrame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
measure: Change in prevalence of COVID-19 related loss of appetite
timeFrame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
measure: Change in general perceived well-being
timeFrame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation
measure: change in D-Dimer level
timeFrame: Day 1 and day 21 of pulmonary rehabilitation
measure: change in c-reactive protein level
timeFrame: Day 1 and day 21 of pulmonary rehabilitation
measure: change in leukocytes level
timeFrame: Day 1 and day 21 of pulmonary rehabilitation
measure: change in hemoglobin level
timeFrame: Day 1 and day 21 of pulmonary rehabilitation
measure: change in troponin level
timeFrame: Day 1 and day 21 of pulmonary rehabilitation
measure: change in pro-brain natriuretic peptide level
timeFrame: Day 1 and day 21 of pulmonary rehabilitation
Other outcomes:
Locations:
city: Schönau Am Königssee
country: Germany
facility: Schön Klinik Berchtesgadener Land
state: Bavaria
Study officials:
affiliation: Philipps University Marburg
name: Andreas R Koczulla, MD
role: PRINCIPAL_INVESTIGATOR
References: