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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-26

Study Completion Date

2024-10-26

Brief Summary

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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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Detailed Description

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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)

Conditions

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Pneumonia Due to COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

random selection to two groups (study group and control group)

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Education program and Pulmonary rehabilitation

Conventional pulmonary rehabilitation coupled with original education program.

Group Type EXPERIMENTAL

Education program

Intervention Type 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

Intervention Type 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.

Pulmonary rehabilitation

Conventional pulmonary rehabilitation

Group Type OTHER

Pulmonary rehabilitation

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No