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

University of Rzeszow

Status: Completed

Conditions: Pneumonia Due to COVID-19

Treatments: Other: Pulmonary rehabilitation; Other: Education program

Study type: Interventional

Funder types: Other

Identifiers

NCT06522724

URzeszow 1/07/2021

Details and patient eligibility

About

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.

Full 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)

Enrollment: 100 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Education program and Pulmonary rehabilitation

Experimental group

Description:

Conventional pulmonary rehabilitation coupled with original education program.

Treatment:

Other: Education program

Other: Pulmonary rehabilitation

Pulmonary rehabilitation

Other group

Description:

Conventional pulmonary rehabilitation

Treatment:

Other: Pulmonary rehabilitation