Education Impact on Rehabilitation of Hospitalized Patients with Chronic Obstructive Pulmonary Disease.

NCT ID: NCT06028711

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-28
• Study Completion Date: 2024-10-07

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 chronic obstructive pulmonary disease.

Detailed 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)

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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 on the benefits of appropriately adapted physical activity, practical tips on airway clearance techniques or physical exercise, and risk factors for exacerbation of COPD.

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 two hours daily. The program will be applied individually to each patient and include 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.

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 two hours daily. The program will be applied individually to each patient and include 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.

Interventions

Education program

Patients in a study group will participate in daily education program 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.

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 two hours daily. The program will be applied individually to each patient and include 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosed chronic obstructive pulmonary disease in the exacerbation phase
• Moderate stage (II) of the disease
• Independence in basic activities of daily living (above 86 points on the Barthel scale)
• Age 55 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

• Diagnosed chronic obstructive pulmonary disease in remission
• Stages I, III and IV of the disease - a forms with mild, severe, and very severe obstruction
• Hospitalization in the intensive care unit, current health condition precluding participation in the study
• Age under 55 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: 55 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rzeszow

OTHER

Sponsor Role: lead

Responsible Party

Renata Borys

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renata Borys, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Rzeszow

Agnieszka Guzik, A/Prof.

Role: STUDY_DIRECTOR

University of Rzeszow

Magdalena Kołodziej, PhD

Role: STUDY_CHAIR

University of Rzeszow

Locations

University of Rzeszów

Rzeszów, , Poland

Countries

Poland

Other Identifiers

URzeszow/2023/06/0034/W

Identifier Type: -

Identifier Source: org_study_id