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Clinical Trial 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 chronic obstructive pulmonary disease.


Clinical Trial Description

The planned group size is 100 patients diagnosed with chronic obstructive pulmonary disease (COPD) and hospitalized due to exacerbation. 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 (50 patients) undergoing pulmonary rehabilitation supplemented with an education program and a control group (50 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 two hours daily. The program will be applied individually to each patient, including active and assisted exercises, effective cough exercises, pursed-lips breathing, positive expiratory pressure exercises, 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 on the benefits of appropriately adapted physical activity, practical tips on airway clearance techniques or physical exercise, and risk factors for exacerbation of COPD. The test will be performed three times: before the start of rehabilitation, after completing the rehabilitation program, and the follow-up after two months from the end of hospitalization to assess long-term effects. After the end of the study, people from the control group will also undergo education. The patients' condition and the rehabilitation effects will be assessed using the following measures: - Dynamic lung capacities (spirometry) - Oxygen saturation and pulse rate (pulse oximeter) - Acid-base balance (gasometry) - Exercise tolerance (6-minute walking test) - Fatigue (modified Borg scale) - Physical performance (Fullerton functional fitness test) - Dyspnea assessment (MRC dyspnea scale) - Quality of life (WHOQOL-BREF) - Anxiety and depression (HADS scale) - Activities of daily living (Lawton IADL scale) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06028711
Study type Interventional
Source University of Rzeszow
Contact Renata Borys, MSc
Phone +48 784 016 220
Email rborys@ur.edu.pl
Status Not yet recruiting
Phase N/A
Start date September 2023
Completion date December 2024

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