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

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ClinicalTrials.gov Identifier: NCT04649918
Recruitment Status : Active, not recruiting
First Posted : December 2, 2020
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Andreas Rembert Koczulla, Schön Klinik Berchtesgadener Land

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.


Condition or disease Intervention/treatment
Covid19 SARS-CoV Infection Pulmonary Rehabilitation Quality of Life Other: pulmonary rehabilitation

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Short and Medium-term Effects of Pulmonary Rehabilitation in Mild to Critical Post-acute COVID-19 - an Observational Trial
Actual Study Start Date : November 25, 2020
Actual Primary Completion Date : January 16, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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




Primary Outcome Measures :
  1. Change in 6-minute walk distance [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation ]
    measure in meter


Secondary Outcome Measures :
  1. change in endurance shuttle walk distance [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation ]
    measure provided in seconds

  2. Change in Diffusion capacity of the lungs for Carbon monoxide [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation ]
    measure provided in % predicted

  3. Change in Forced Vital Capacity [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation ]
    measure provided in % predicted

  4. Change in total lung capacity [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation ]
    measure provided in % predicted

  5. change in Montreal cognitive assessment test [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation ]
    score ranges from 0 to 30 with lower score indicating higher cognitive impairment

  6. change in short-form 36 question health survey [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation ]
    score ranges from 0 to 100 with higher scores indicating better Quality of life

  7. change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29) [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation ]
    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.

  8. Change in the scale of general anxiety disorder - 7 questionnaire (GAD-7) [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation ]
    score ranges from 0 to 21 with higher scores indicating more severe anxiety

  9. Change in the scale of the patient health questionnaire - Depression (PHQ-D) [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation ]
    score ranges from 0 to 27 with higher scores indicating more severe depression

  10. Change in prevalence of COVID-19 related dyspnea [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation ]
    patients will be asked if they still perceive COVID-19 related dyspnea: answer possibilities yes or no

  11. Change in prevalence of COVID-19 related cough [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation ]
    patients will be asked if they still perceive COVID-19 related cough: answer possibilities yes or no

  12. Change in prevalence of COVID-19 related cognitive impairment [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation ]
    patients will be asked if they still perceive COVID-19 related cognitive impairment: answer possibilities yes or no

  13. Change in prevalence of COVID-19 related loss of appetite [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation ]
    patients will be asked if they still perceive COVID-19 related loss of appetite: answer possibilities yes or no

  14. Change in general perceived well-being [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation ]
    scale from 1 (worst) to 10 (best)

  15. change in D-Dimer level [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation ]
    in mg/l

  16. change in c-reactive protein level [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation ]
    in mg/l

  17. change in leukocytes level [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation ]
    in g/l

  18. change in hemoglobin level [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation ]
    in g/dl

  19. change in troponin level [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation ]
    in pg/ml

  20. change in pro-brain natriuretic peptide level [ Time Frame: Day 1 and day 21 of pulmonary rehabilitation ]
    in pg/ml



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients referred for an inpatient pulmonary rehabilitation program at the reference center will be recruited
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649918


Locations
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Germany
Schön Klinik Berchtesgadener Land
Schönau Am Königssee, Bavaria, Germany, 83471
Sponsors and Collaborators
Schön Klinik Berchtesgadener Land
Investigators
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Principal Investigator: Andreas R Koczulla, MD Philipps University Marburg Medical Center
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Responsible Party: Prof. Dr. Andreas Rembert Koczulla, Professor, Schön Klinik Berchtesgadener Land
ClinicalTrials.gov Identifier: NCT04649918    
Other Study ID Numbers: COVID-Rehab
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases