Education Impact on Rehabilitation of Hospitalized Patients With Pneumonia and COVID-19

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia Due to COVID-19
• Intervention / Treatment: Other: Education program; Other: Pulmonary rehabilitation

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Rzeszów, Poland, 35-959
    • University of Rzeszow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Education program and Pulmonary rehabilitation; Conventional pulmonary rehabilitation coupled with original education program.	Other: Education program; 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.; Other: Pulmonary rehabilitation; 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.
Other: Pulmonary rehabilitation; Conventional pulmonary rehabilitation	Other: Pulmonary rehabilitation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Second examination- at the end 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.	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.	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).	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).	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).	First examination- before the start of the 14-day rehabilitation program

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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.	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).	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).	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).	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).	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.	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).	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).	Second examination- at the end of the 14-day rehabilitation program

Collaborators and Investigators

• Sponsor: University of Rzeszow
• Investigators: Principal Investigator: Renata Borys, MSc, University of Rzeszow; Study Chair: Magdalena Kołodziej, PhD, University of Rzeszow; Study Director: Agnieszka Guzik, A/Prof, University of Rzeszow

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2024
• Primary Completion (Actual): September 26, 2024
• Study Completion (Actual): October 26, 2024

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; pneumonia; pulmonary rehabilitation; patients' education
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Pneumonia
• Other Study ID Numbers: URzeszow 1/07/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No