Clinical trial NCT06028711: Education Impact on Rehabilitation of Hospitalized Patients with Chronic Obstructive Pulmonary Disease.
Official title: The Impact of Education on the Rehabilitation of Patients Hospitalized Due to Chronic Obstructive Pulmonary Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: pulmonary rehabilitation
COPD patients' education
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 100
Sex: ALL
Minimum age (years): 55
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 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)

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.

Primary outcomes:
measure: Dynamic lung capacities (spirometry)
timeFrame: First examination- before the start of the interventions
measure: Dynamic lung capacities (spirometry)
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Modified Tiffeneau-Pinelli index (spirometry)
timeFrame: First examination- before the start of the interventions
measure: Modified Tiffeneau-Pinelli index (spirometry)
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Oxygen saturation
timeFrame: First examination- before the start of the interventions
measure: Oxygen saturation
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Pulse rate
timeFrame: First examination- before the start of the interventions
measure: Pulse rate
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Acid-base balance
timeFrame: First examination- before the start of the interventions
measure: Acid-base balance
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Exercise tolerance assessed by 6-minute walking test (6MWT)
timeFrame: First examination- before the start of the interventions
measure: Exercise tolerance assessed by 6-minute walking test (6MWT)
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Physical performance assessment by Fullerton functional fitness test
timeFrame: First examination- before the start of the interventions
measure: Physical performance assessment by Fullerton functional fitness test
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 interventions
measure: Fatigue assessment using modified Borg scale
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Fatigue assessment using modified Borg scale
timeFrame: Third examination - two months after discharge from the hospital (follow- up)
measure: Dyspnea assessment with Medical Research Council dyspnea scale
timeFrame: First examination- before the start of the interventions
measure: Dyspnea assessment with Medical Research Council dyspnea scale
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Dyspnea assessment with Medical Research Council dyspnea scale
timeFrame: Third examination - two months after discharge from the hospital (follow- up)
measure: Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
timeFrame: First examination- before the start of the interventions
measure: Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
timeFrame: Third examination - two months after discharge from the hospital (follow- up)
measure: Anxiety and depression assessment using HADS scale
timeFrame: First examination- before the start of the interventions
measure: Anxiety and depression assessment using HADS scale
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Anxiety and depression assessment using HADS scale
timeFrame: Third examination - two months after discharge from the hospital (follow- up)
measure: Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale
timeFrame: First examination- before the start of the interventions
measure: Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale
timeFrame: Second examination- at the end of the 14-day rehabilitation program
measure: Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale
timeFrame: Third examination - two months after discharge from the hospital (follow- up)
Secondary outcomes:
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: