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Covid19STEPCONCT04649918

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

An observational study of Covid19 and SARS-CoV Infection, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
pulmonary rehabilitation
How many people
50 participants
Where
1 siteGermany
Study dates
25 Nov 2020to 16 Jan 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Post-acute phase COVID-19 patients with mild, moderate, severe or critical course
  • written informed consent

Who cannot join

  • patients who are unable to walk

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Schön Klinik Berchtesgadener Land

    Schönau am Königssee, Bavaria, 83471

Other trials in Germany

About this study

Official title: 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.

Read more

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.

Being tested
pulmonary rehabilitation
Medical subject headings
COVID-19, Severe Acute Respiratory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pulmonary rehabilitationOther

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

Study groups in NCT04649918
Study groupRoleWhat they receive
mild to moderate COVID 19patients post-acute mild to moderate COVID 19
Receives: Other: pulmonary rehabilitation
severe to critical COVID 19patients post-acute severe to critical COVID 19
Receives: Other: pulmonary rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 6-minute walk distance

    measure in meter

    Measured: Day 1 and day 21 of pulmonary rehabilitation

Secondary outcomes (20)

  1. change in endurance shuttle walk distance

    measure provided in seconds

    Measured: Day 1 and day 21 of pulmonary rehabilitation

  2. Change in Diffusion capacity of the lungs for Carbon monoxide

    measure provided in % predicted

    Measured: Day 1 and day 21 of pulmonary rehabilitation

  3. Change in Forced Vital Capacity

    measure provided in % predicted

    Measured: Day 1 and day 21 of pulmonary rehabilitation

  4. Change in total lung capacity

    measure provided in % predicted

    Measured: Day 1 and day 21 of pulmonary rehabilitation

  5. change in Montreal cognitive assessment test

    score ranges from 0 to 30 with lower score indicating higher cognitive impairment

    Measured: Day 1 and day 21 of pulmonary rehabilitation

  6. change in short-form 36 question health survey

    score ranges from 0 to 100 with higher scores indicating better Quality of life

    Measured: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

  7. 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.

    Measured: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

  8. 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

    Measured: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

  9. 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

    Measured: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

  10. 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

    Measured: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

  11. 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

    Measured: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

  12. 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

    Measured: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

  13. 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

    Measured: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

  14. Change in general perceived well-being

    scale from 1 (worst) to 10 (best)

    Measured: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

  15. change in D-Dimer level

    in mg/l

    Measured: Day 1 and day 21 of pulmonary rehabilitation

  16. change in c-reactive protein level

    in mg/l

    Measured: Day 1 and day 21 of pulmonary rehabilitation

  17. change in leukocytes level

    in g/l

    Measured: Day 1 and day 21 of pulmonary rehabilitation

  18. change in hemoglobin level

    in g/dl

    Measured: Day 1 and day 21 of pulmonary rehabilitation

  19. change in troponin level

    in pg/ml

    Measured: Day 1 and day 21 of pulmonary rehabilitation

  20. change in pro-brain natriuretic peptide level

    in pg/ml

    Measured: Day 1 and day 21 of pulmonary rehabilitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2020
  2. Study start25 Nov 2020
  3. Primary completion16 Jan 2021
  4. Study completion16 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04649918
Sponsor's protocol ID
COVID-Rehab
Acronym
STEPCO
Status last verified
Dec 2021
First submitted
25 Nov 2020
Last updated
23 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and SARS-CoV Infection, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 6-minute walk distance (time frame: Day 1 and day 21 of pulmonary rehabilitation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04649918.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2021.

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