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

Covid19 Clinical Trial

— STEPCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04649918
• Other study ID #: COVID-Rehab
• Status: Completed
• Start date: November 25, 2020
• Est. completion date: January 16, 2021

Study information

• Verified date: December 2021
• Source: Schön Klinik Berchtesgadener Land
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 16, 2021
• Est. primary completion date: January 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Pulmonary Rehabilitation
• Quality of Life
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

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

Locations

Country	Name	City	State
Germany	Schön Klinik Berchtesgadener Land	Schönau Am Königssee	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Schön Klinik Berchtesgadener Land

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6-minute walk distance	measure in meter	Day 1 and day 21 of pulmonary rehabilitation
Secondary	change in endurance shuttle walk distance	measure provided in seconds	Day 1 and day 21 of pulmonary rehabilitation
Secondary	Change in Diffusion capacity of the lungs for Carbon monoxide	measure provided in % predicted	Day 1 and day 21 of pulmonary rehabilitation
Secondary	Change in Forced Vital Capacity	measure provided in % predicted	Day 1 and day 21 of pulmonary rehabilitation
Secondary	Change in total lung capacity	measure provided in % predicted	Day 1 and day 21 of pulmonary rehabilitation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	change in D-Dimer level	in mg/l	Day 1 and day 21 of pulmonary rehabilitation
Secondary	change in c-reactive protein level	in mg/l	Day 1 and day 21 of pulmonary rehabilitation
Secondary	change in leukocytes level	in g/l	Day 1 and day 21 of pulmonary rehabilitation
Secondary	change in hemoglobin level	in g/dl	Day 1 and day 21 of pulmonary rehabilitation
Secondary	change in troponin level	in pg/ml	Day 1 and day 21 of pulmonary rehabilitation
Secondary	change in pro-brain natriuretic peptide level	in pg/ml	Day 1 and day 21 of pulmonary rehabilitation