An interventional study of Education program and Pulmonary rehabilitation in Pneumonia Due to COVID-19, sponsored by University of Rzeszow. Completed at 1 site in Poland. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by University of Rzeszow · Not applicable, Interventional, and Treatment
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.
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:
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Exclusion Criteria:
Conventional pulmonary rehabilitation coupled with original education program.
Other: Education program · Other: Pulmonary rehabilitation
Conventional pulmonary rehabilitation
Other: Pulmonary rehabilitation
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.
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.
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Second examination- at the end 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Second examination- at the end of the 14-day rehabilitation program
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University of Rzeszow