Clinical trial NCT06522724: Education Impact on Rehabilitation of Hospitalized Patients With Pneumonia and COVID-19
Official title: The Impact of Education on the Rehabilitation of Patients Hospitalized Due to Pneumonia With Confirmed COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia Due to COVID-19
Keywords: pulmonary rehabilitation
COVID-19
pneumonia
patients' education
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: random selection to two groups (study group and control group)
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Vital capacity (Voldyne 5000)
timeFrame: First examination- before the start of the 14-day rehabilitation program
measure: Vital capacity (Voldyne 5000)
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Oxygen saturation
timeFrame: First examination- before the start of the 14-day rehabilitation program
measure: Oxygen saturation
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Acid-base balance
timeFrame: First examination- before the start of the 14-day rehabilitation program
measure: Acid-base balance
timeFrame: Second examination- at the end of the 14-day rehabilitation program
Secondary outcomes:
measure: Physical performance assessment by Sit-to-Stand Test (STS)
timeFrame: First examination- before the start of the 14-day rehabilitation program
measure: Physical performance assessment by Sit-to-Stand Test (STS)
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Fatigue assessment using modified Borg scale
timeFrame: First examination- before the start of the 14-day rehabilitation program
measure: Fatigue assessment using modified Borg scale
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Dyspnea assessment with Medical Research Council dyspnea scale
timeFrame: First examination- before the start of the 14-day rehabilitation program
measure: Dyspnea assessment with Medical Research Council dyspnea scale
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Anxiety and depression assessment using HADS scale
timeFrame: First examination- before the start of the 14-day rehabilitation program
measure: Anxiety and depression assessment using HADS scale
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Activities of daily living assesment using Barthel scale
timeFrame: First examination- before the start of the 14-day rehabilitation program
measure: Activities of daily living assesment using Barthel scale
timeFrame: Second examination- at the end of the 14-day rehabilitation program
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: University of Rzeszów
Study officials:
affiliation: University of Rzeszow
name: Renata Borys, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rzeszow
name: Agnieszka Guzik, A/Prof
role: STUDY_DIRECTOR
affiliation: University of Rzeszow
name: Magdalena Kołodziej, PhD
role: STUDY_CHAIR
References: