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

NCT06522724 | Completed

• 1 other identifier: URzeszow 1/07/2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumonia Due to COVID-19

Keywords

pulmonary rehabilitation; COVID-19; pneumonia; patients' education

Outcome Measures

Primary Outcomes (6)

• 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

• 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

Secondary Outcomes (10)

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

  First examination- before the start of the 14-day rehabilitation program

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

  Second examination- at the end of the 14-day rehabilitation program

• Fatigue assessment using modified Borg scale

  First examination- before the start of the 14-day rehabilitation program

• Fatigue assessment using modified Borg scale

  Second examination- at the end of the 14-day rehabilitation program

• Dyspnea assessment with Medical Research Council dyspnea scale

  First examination- before the start of the 14-day rehabilitation program

Study Arms (2)

Education program and Pulmonary rehabilitation

EXPERIMENTAL

Conventional pulmonary rehabilitation coupled with original education program.

Other: Education program; Other: Pulmonary rehabilitation

Pulmonary rehabilitation

OTHER

Conventional pulmonary rehabilitation

Other: Pulmonary rehabilitation

Interventions

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.

Education program and Pulmonary rehabilitation

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.

Education program and Pulmonary rehabilitation; Pulmonary rehabilitation

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rzeszow: lead

Study Sites (1)

University of Rzeszów

Rzeszów, 35-959, Poland

Location

MeSH Terms

Conditions

COVID-19; Pneumonia

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Renata Borys, MSc

  University of Rzeszow

  PRINCIPAL INVESTIGATOR

• Agnieszka Guzik, A/Prof

  University of Rzeszow

  STUDY DIRECTOR

• Magdalena Kołodziej, PhD

  University of Rzeszow

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Model Details: random selection to two groups (study group and control group)

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 26, 2024
• Study Start: July 26, 2024
• Primary Completion: September 26, 2024
• Study Completion: October 26, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

PL (1)