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NCT Number: NCT06522724

Education Impact on Rehabilitation of Hospitalized Patients With Pneumonia and 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.

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Key information

Conditions

Pneumonia Due to COVID-19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rzeszów

Rzeszów, 35-959, Poland

About this study

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)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Education program

Other

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 Rehabilitation

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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).

  6. 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).

Secondary outcomes

  1. Physical performance assessment by Sit-to-Stand Test (STS)

    Time frame: First examination- before the start of the 14-day rehabilitation program

    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).

  2. Physical performance assessment by Sit-to-Stand Test (STS)

    Time frame: Second examination- at the end of the 14-day rehabilitation program

    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).

  3. Fatigue assessment using modified Borg scale

    Time frame: First examination- before the start of the 14-day rehabilitation program

    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).

  4. Fatigue assessment using modified Borg scale

    Time frame: Second examination- at the end of the 14-day rehabilitation program

    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).

  5. Dyspnea assessment with Medical Research Council dyspnea scale

    Time frame: First examination- before the start of the 14-day rehabilitation program

    Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).

  6. Dyspnea assessment with Medical Research Council dyspnea scale

    Time frame: Second examination- at the end of the 14-day rehabilitation program

    Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).

  7. Anxiety and depression assessment using HADS scale

    Time frame: First examination- before the start of the 14-day rehabilitation program

    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.

  8. Anxiety and depression assessment using HADS scale

    Time frame: Second examination- at the end of the 14-day rehabilitation program

    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.

  9. Activities of daily living assesment using Barthel scale

    Time frame: First examination- before the start of the 14-day rehabilitation program

    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).

  10. Activities of daily living assesment using Barthel scale

    Time frame: Second examination- at the end of the 14-day rehabilitation program

    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).

Sponsors and collaborators

Lead sponsor

University of Rzeszow

Other

Registry information

Official study title

The Impact of Education on the Rehabilitation of Patients Hospitalized Due to Pneumonia With Confirmed COVID-19

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2024
Registry last updated
Nov 6, 2024

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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