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

University of Rzeszow

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Education program; Other: Pulmonary rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06028711

URzeszow/2023/06/0034/W

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 chronic obstructive pulmonary disease.

Full 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)

Enrollment: 100 patients

Sex: All

Ages: 55 to 70 years old

Volunteers: No Healthy Volunteers

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.

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: Pulmonary rehabilitation

Other: Education program

Pulmonary rehabilitation

Other group

Description:

Conventional pulmonary rehabilitation

Treatment:

Other: Pulmonary rehabilitation