Pneumonia Due to COVID-19NCT06522724
Education Impact on Rehabilitation of Hospitalized Patients With Pneumonia and COVID-19
A study testing Education program and Pulmonary rehabilitation in people with Pneumonia Due to COVID-19, run by University of Rzeszow at 1 site in Poland.
Trial summary
The planned research will enable the assessment of rehabilitation's effects using two pulmonary rehabilitation models: conventional and supplemented with an education program for patients hospitalized due to pneumonia with confirmed COVID-19. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Pneumonia Due to COVID-19
- What is being tested?
- Education program and Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 26 Jul 2024to 26 Oct 2024
- Phase
- Interventional
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalization due to pneumonia due to COVID-19
- Positive SARS-COV-2 PCR test
- Independence in in-bed sitting position with lower extremities placed on the floor
- Age 40 y.o. to 70 y.o.
- No additional respiratory support (e.a. cardiopulmonary bypass machine, ventilator)
- Informed, voluntary consent to participate in research.
Who cannot join
- Hospitalization due to pneumonia with negative SARS-COV-2 PCR test
- Unstable medical condition hindering performing the examination
- Age under 40 y.o. and over 70 y.o.
- Cognitive deficits impairing the ability to understand and execute commands
- Concomitant oncological, neurological, orthopedic, and psychiatric diseases may affect the examined persons' circulatory and respiratory functions, functional efficiency, quality of life, and emotional state.
- Failure to complete a 14-day rehabilitation program
- Lack of informed, voluntary consent to participate in research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Education on the Rehabilitation of Patients Hospitalized Due to Pneumonia With Confirmed COVID-19
The planned research will enable the assessment of rehabilitation's effects using two pulmonary rehabilitation models: conventional and supplemented with an education program for patients hospitalized due to pneumonia with confirmed COVID-19.
Read the detailed description
The planned group size is 60 patients diagnosed with pneumonia and confirmed COVID-19. The given population was calculated based on the sampling calculator, considering the following parameters: fraction size, confidence level, and maximum error. Eligible patients will be randomly divided into two groups: a study group (30 patients) undergoing pulmonary rehabilitation supplemented with an education program, and a control group (30 patients) undergoing conventional pulmonary rehabilitation. Patients of both groups will be included in a 14-day rehabilitation program (Monday to Saturday). Treatments and therapies will be continued for a maximum of three hours daily. The program will be applied individually to each patient and include in-bed assisted exercises, airway clearance techniques, effective cough exercises, pursed-lips breathing, exercises to strengthen the diaphragm and intercostal muscles and cardiopulmonary exercises. Patients from the study group will additionally undergo daily education using an original brochure containing information about self management during the treatment process, the benefits of appropriately adapted physical activity, practical tips on airway clearance techniques or physical exercise. The test will be performed two times: before the start of rehabilitation and after completing the rehabilitation program. The patients' condition and the rehabilitation effects will be assessed using the following measures:
- Vital capacity (Voldyne 5000)
- Oxygen saturation (pulse oximeter)
- Acid-base balance (gasometry)
- Fatigue (modified Borg scale)
- Physical performance (Sit-to-Stand Test)
- Dyspnea assessment (MRC dyspnea scale)
- Anxiety and depression (HADS scale)
- Activities of daily living (Barthel scale)
- Conditions
- Pneumonia Due to COVID-19
- Being tested
- Education program, Pulmonary rehabilitation
- Keywords
- pulmonary rehabilitation, COVID-19, pneumonia, patients' education
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education programOther
Patients in a study group will participate in daily education program using an original brochure containing information about self-management during the treatment process, the benefits of appropriately adapted physical activity, practical tips on airway clearance techniques or physical exercise.
Pulmonary rehabilitationOther
The patients will participate in a 14-day rehabilitation program (Monday to Saturday). Treatments and therapies will be continued for a maximum of three hours daily. The program will be applied individually to each patient and include in-bed assisted exercises, airway clearance techniques, effective cough exercises, pursed-lips breathing, exercises to strengthen the diaphragm and intercostal muscles and cardiopulmonary exercises.
| Study group | Role | What they receive |
|---|---|---|
| Education program and Pulmonary rehabilitation | Experimental | Conventional pulmonary rehabilitation coupled with original education program. Receives: Other: Education program; Other: Pulmonary rehabilitation |
| Pulmonary rehabilitation | Other | Conventional pulmonary rehabilitation Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital capacity (Voldyne 5000)
Measurements will be performed with certified motivational spirometer, Voldyne 5000. Patient, in a sitting position, will inhale as much air as possible starting from residual volume (RV) level and approach to vital capacity (VC) level. The result will be read from the scale placed on the wall of the device.
Measured: First examination- before the start of the 14-day rehabilitation program
Vital capacity (Voldyne 5000)
Measurements will be performed with certified motivational spirometer, Voldyne 5000. Patient, in a sitting position, will inhale as much air as possible starting from residual volume (RV) level and approach to vital capacity (VC) level. The result will be read from the scale placed on the wall of the device.
Measured: Second examination- at the end of the 14-day rehabilitation program
Oxygen saturation
Measurements will be performed with pulse oximeter and the parameter analyzed will be SpO2 (oxygen saturation by pulse oximetry; percentage of oxygen in patients' blood).
Measured: First examination- before the start of the 14-day rehabilitation program
Oxygen saturation
Measurements will be performed with pulse oximeter and the parameter analyzed will be SpO2 (oxygen saturation by pulse oximetry; percentage of oxygen in patients' blood).
Measured: Second examination- at the end of the 14-day rehabilitation program
Acid-base balance
The gasometry results will be taken from patients' medical documentation. The parameters analyzed will be oxygen pressure (pO2) and carbon dioxide pressure (pCO2).
Measured: First examination- before the start of the 14-day rehabilitation program
Acid-base balance
The gasometry results will be taken from patients' medical documentation. The parameters analyzed will be oxygen pressure (pO2) and carbon dioxide pressure (pCO2).
Measured: Second examination- at the end of the 14-day rehabilitation program
Secondary outcomes (10)
Physical performance assessment by Sit-to-Stand Test (STS)
The test will be performed starting in sitting position in the chair with straight back, feet flat on the floor, and arms crossed over the chest or placed on the thighs. The patient will be instructed to stand up fully from the seated position and then sit back down as quickly and safely as possible during 30 seconds (number of standings in 30 seconds).
Measured: First examination- before the start of the 14-day rehabilitation program
Physical performance assessment by Sit-to-Stand Test (STS)
The test will be performed starting in sitting position in the chair with straight back, feet flat on the floor, and arms crossed over the chest or placed on the thighs. The patient will be instructed to stand up fully from the seated position and then sit back down as quickly and safely as possible during 30 seconds (number of standings in 30 seconds).
Measured: Second examination- at the end of the 14-day rehabilitation program
Fatigue assessment using modified Borg scale
Fatigue will be examined during physical activity and the level of fatigue will be marked on a scale from 1 (no fatigue) to 10 (very very hard fatigue).
Measured: First examination- before the start of the 14-day rehabilitation program
Fatigue assessment using modified Borg scale
Fatigue will be examined during physical activity and the level of fatigue will be marked on a scale from 1 (no fatigue) to 10 (very very hard fatigue).
Measured: Second examination- at the end of the 14-day rehabilitation program
Dyspnea assessment with Medical Research Council dyspnea scale
Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).
Measured: First examination- before the start of the 14-day rehabilitation program
Dyspnea assessment with Medical Research Council dyspnea scale
Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).
Measured: Second examination- at the end of the 14-day rehabilitation program
Anxiety and depression assessment using HADS scale
The scale consists of 16 statements to which the respondent refers on a four-point scale. Eight statements are used to measure anxiety and depression, each of which is rated on a scale of 0 to 3 points. The cut-off threshold is 7 points for depression and 7 points for anxiety. The intensity of depressed mood and anxiety will be analyzed.
Measured: First examination- before the start of the 14-day rehabilitation program
Anxiety and depression assessment using HADS scale
The scale consists of 16 statements to which the respondent refers on a four-point scale. Eight statements are used to measure anxiety and depression, each of which is rated on a scale of 0 to 3 points. The cut-off threshold is 7 points for depression and 7 points for anxiety. The intensity of depressed mood and anxiety will be analyzed.
Measured: Second examination- at the end of the 14-day rehabilitation program
Activities of daily living assesment using Barthel scale
The Barthel Scale will be used to measure patient's ability to perform activities of daily living (ADLs) independently, with scores ranging from 0 (completely dependent) to 100 (completely independent).
Measured: First examination- before the start of the 14-day rehabilitation program
Activities of daily living assesment using Barthel scale
The Barthel Scale will be used to measure patient's ability to perform activities of daily living (ADLs) independently, with scores ranging from 0 (completely dependent) to 100 (completely independent).
Measured: Second examination- at the end of the 14-day rehabilitation program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start26 Jul 2024
- Primary completion26 Sep 2024
- Study completion26 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia Due to COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- random selection to two groups (study group and control group)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renata Borys, University of Rzeszow
- Investigators
- Renata Borys, MSc, Principal investigator, University of RzeszowAgnieszka Guzik, A/Prof, Study director, University of RzeszowMagdalena Kołodziej, PhD, Study chair, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522724
- Sponsor's protocol ID
- URzeszow 1/07/2021
- Status last verified
- Nov 2024
- First submitted
- 19 Jul 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Education on the Rehabilitation of Patients Hospitalized Due to Pneumonia With Confirmed COVID-19
- ClinicalTrials.gov ID
- NCT06522724
- Acronym / sponsor ID
- URzeszow 1/07/2021
- Conditions
- Pneumonia Due to COVID-19
- Keywords
- pulmonary rehabilitation, COVID-19, pneumonia, patients' education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 26 Oct 2024 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The planned research will enable the assessment of rehabilitation's effects using two pulmonary rehabilitation models: conventional and supplemented with an education program for patients hospitalized due to pneumonia with confirmed COVID-19.
Detailed description
The planned group size is 60 patients diagnosed with pneumonia and confirmed COVID-19. The given population was calculated based on the sampling calculator, considering the following parameters: fraction size, confidence level, and maximum error. Eligible patients will be randomly divided into two groups: a study group (30 patients) undergoing pulmonary rehabilitation supplemented with an education program, and a control group (30 patients) undergoing conventional pulmonary rehabilitation. Patients of both groups will be included in a 14-day rehabilitation program (Monday to Saturday). Treatments and therapies will be continued for a maximum of three hours daily. The program will be applied individually to each patient and include in-bed assisted exercises, airway clearance techniques, effective cough exercises, pursed-lips breathing, exercises to strengthen the diaphragm and intercostal muscles and cardiopulmonary exercises. Patients from the study group will additionally undergo daily education using an original brochure containing information about self management during the treatment process, the benefits of appropriately adapted physical activity, practical tips on airway clearance techniques or physical exercise. The test will be performed two times: before the start of rehabilitation and after completing the rehabilitation program. The patients' condition and the rehabilitation effects will be assessed using the following measures:
- Vital capacity (Voldyne 5000)
- Oxygen saturation (pulse oximeter)
- Acid-base balance (gasometry)
- Fatigue (modified Borg scale)
- Physical performance (Sit-to-Stand Test)
- Dyspnea assessment (MRC dyspnea scale)
- Anxiety and depression (HADS scale)
- Activities of daily living (Barthel scale)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- random selection to two groups (study group and control group)
| Arm | Type | Receives |
|---|---|---|
| Education program and Pulmonary rehabilitation | Experimental | Other: Education program, Other: Pulmonary rehabilitationConventional pulmonary rehabilitation coupled with original education program. |
| Pulmonary rehabilitation | Other | Other: Pulmonary rehabilitationConventional pulmonary rehabilitation |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hospitalization due to pneumonia due to COVID-19
- Positive SARS-COV-2 PCR test
- Independence in in-bed sitting position with lower extremities placed on the floor
- Age 40 y.o. to 70 y.o.
- No additional respiratory support (e.a. cardiopulmonary bypass machine, ventilator)
Key exclusion criteria (7 listed)
- Hospitalization due to pneumonia with negative SARS-COV-2 PCR test
- Unstable medical condition hindering performing the examination
- Age under 40 y.o. and over 70 y.o.
- Cognitive deficits impairing the ability to understand and execute commands
- Concomitant oncological, neurological, orthopedic, and psychiatric diseases may affect the examined persons' circulatory and respiratory functions, functional efficiency, quality of life, and emotional state.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education programPatients in a study group will participate in daily education program using an original brochure containing information about self-management during the treatment process, the benefits of appropriately adapted physical activity, practical tips on airway clearance techniques or physical exercise. | Other | Education program and Pulmonary rehabilitation |
| Pulmonary rehabilitationThe patients will participate in a 14-day rehabilitation program (Monday to Saturday). Treatments and therapies will be continued for a maximum of three hours daily. The program will be applied individually to each patient and include in-bed assisted exercises, airway clearance techniques, effective cough exercises, pursed-lips breathing, exercises to strengthen the diaphragm and intercostal muscles and cardiopulmonary exercises. | Other | Education program and Pulmonary rehabilitation, Pulmonary rehabilitation |
Primary outcome
Vital capacity (Voldyne 5000)
Time frame: First examination- before the start of the 14-day rehabilitation program
Measurements will be performed with certified motivational spirometer, Voldyne 5000. Patient, in a sitting position, will inhale as much air as possible starting from residual volume (RV) level and approach to vital capacity (VC) level. The result will be read from the scale placed on the wall of the device.
Vital capacity (Voldyne 5000)
Time frame: Second examination- at the end of the 14-day rehabilitation program
Measurements will be performed with certified motivational spirometer, Voldyne 5000. Patient, in a sitting position, will inhale as much air as possible starting from residual volume (RV) level and approach to vital capacity (VC) level. The result will be read from the scale placed on the wall of the device.
Oxygen saturation
Time frame: First examination- before the start of the 14-day rehabilitation program
Measurements will be performed with pulse oximeter and the parameter analyzed will be SpO2 (oxygen saturation by pulse oximetry; percentage of oxygen in patients' blood).
Oxygen saturation
Time frame: Second examination- at the end of the 14-day rehabilitation program
Measurements will be performed with pulse oximeter and the parameter analyzed will be SpO2 (oxygen saturation by pulse oximetry; percentage of oxygen in patients' blood).
Acid-base balance
Time frame: First examination- before the start of the 14-day rehabilitation program
The gasometry results will be taken from patients' medical documentation. The parameters analyzed will be oxygen pressure (pO2) and carbon dioxide pressure (pCO2).
Acid-base balance
Time frame: Second examination- at the end of the 14-day rehabilitation program
The gasometry results will be taken from patients' medical documentation. The parameters analyzed will be oxygen pressure (pO2) and carbon dioxide pressure (pCO2).
10 secondary outcomes
Physical performance assessment by Sit-to-Stand Test (STS)
Time frame: First examination- before the start of the 14-day rehabilitation program
Physical performance assessment by Sit-to-Stand Test (STS)
Time frame: Second examination- at the end of the 14-day rehabilitation program
Fatigue assessment using modified Borg scale
Time frame: First examination- before the start of the 14-day rehabilitation program
Fatigue assessment using modified Borg scale
Time frame: Second examination- at the end of the 14-day rehabilitation program
Dyspnea assessment with Medical Research Council dyspnea scale
Time frame: First examination- before the start of the 14-day rehabilitation program
Dyspnea assessment with Medical Research Council dyspnea scale
Time frame: Second examination- at the end of the 14-day rehabilitation program
Anxiety and depression assessment using HADS scale
Time frame: First examination- before the start of the 14-day rehabilitation program
Anxiety and depression assessment using HADS scale
Time frame: Second examination- at the end of the 14-day rehabilitation program
Activities of daily living assesment using Barthel scale
Time frame: First examination- before the start of the 14-day rehabilitation program
Activities of daily living assesment using Barthel scale
Time frame: Second examination- at the end of the 14-day rehabilitation program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renata Borys, MSc principal investigator
University of Rzeszow
Agnieszka Guzik, A/Prof study director
University of Rzeszow
Magdalena Kołodziej, PhD study chair
University of Rzeszow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education program and Pulmonary rehabilitation in people with Pneumonia Due to COVID-19, run by University of Rzeszow at 1 site in Poland.
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 6 inclusion and 7 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 6 Nov 2024. 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 Poland. 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?
Vital capacity (Voldyne 5000) (time frame: First examination- before the start of the 14-day rehabilitation program). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2024.