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Completed

NCT Number: NCT04649918

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Schön Klinik Berchtesgadener Land

Schönau am Königssee, Bavaria, 83471, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary Rehabilitation

Other

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

Primary outcomes

  1. Change in 6-minute walk distance

    Time frame: Day 1 and day 21 of pulmonary rehabilitation

    measure in meter

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Registry information

Official study title

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

Acronym: STEPCO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2020
Registry last updated
Dec 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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