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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The Impact of Education on the Rehabilitation of Patients Hospitalized Due to Chronic Obstructive Pulmonary Disease.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06028711
• Other study ID #: URzeszow/2023/06/0034/W
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: University of Rzeszow
• Contact: Renata Borys, MSc
• Phone: +48 784 016 220
• Email: rborys[@]ur.edu.pl
• Is FDA regulated: No
• Study type: Interventional

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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Poland	University of Rzeszów	Rzeszów

Sponsors (1)

Lead Sponsor	Collaborator
University of Rzeszow

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic lung capacities (spirometry)	Measurements will be performed with certified spirometer and the parameters analyzed will be Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) measured in litres [L].	First examination- before the start of the interventions
Primary	Dynamic lung capacities (spirometry)	Measurements will be performed with certified spirometer and the parameters analyzed will be Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) measured in litres [L].	Second examination- at the end of the 14-day rehabilitation program
Primary	Modified Tiffeneau-Pinelli index (spirometry)	Measurement will be performed with certified spirometer and the parameter analyzed will be the ratio of Forced Expiratory Volume in 1 Second to Forced Vital Capacity (FEV1/FVC ratio) presented as a decimal fraction.	First examination- before the start of the interventions
Primary	Modified Tiffeneau-Pinelli index (spirometry)	Measurement will be performed with certified spirometer and the parameter analyzed will be the ratio of Forced Expiratory Volume in 1 Second to Forced Vital Capacity (FEV1/FVC ratio) presented as a decimal fraction.	Second examination- at the end of the 14-day rehabilitation program
Primary	Oxygen saturation	Measurements will be performed with pulse oximeter and the parameter analyzed will be oxygen saturation by pulse oximetry (SpO2, percentage of oxygen in patients' blood).	First examination- before the start of the interventions
Primary	Oxygen saturation	Measurements will be performed with pulse oximeter and the parameter analyzed will be oxygen saturation by pulse oximetry (SpO2, percentage of oxygen in patients' blood).	Second examination- at the end of the 14-day rehabilitation program
Primary	Pulse rate	Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.	First examination- before the start of the interventions
Primary	Pulse rate	Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.	Second examination- at the end of the 14-day rehabilitation program
Primary	Acid-base balance	The gasometry results will be taken from patients' medical documentation. The parameters analyzed will be oxygen pressure (pO2) and carbon dioxide pressure (pCO2).	First examination- before the start of the interventions
Primary	Acid-base balance	The gasometry results will be taken from patients' medical documentation. The parameters analyzed will be oxygen pressure (pO2) and carbon dioxide pressure (pCO2).	Second examination- at the end of the 14-day rehabilitation program
Primary	Exercise tolerance assessed by 6-minute walking test (6MWT)	The test will be performed in 20-meter long hospital corridor. The patient should walk the distance at his own rhythm and pace, using orthopedic aids (if necessary). The patient will be informed that they can stop the test at any time if they feel it is necessary. The distance traveled in meters in 6 minutes will be analyzed.	First examination- before the start of the interventions
Primary	Exercise tolerance assessed by 6-minute walking test (6MWT)	The test will be performed in 20-meter long hospital corridor. The patient should walk the distance at his own rhythm and pace, using orthopedic aids (if necessary). The patient will be informed that they can stop the test at any time if they feel it is necessary. The distance traveled in meters in 6 minutes will be analyzed.	Second examination- at the end of the 14-day rehabilitation program
Primary	Physical performance assessment by Fullerton functional fitness test	The test comprising muscle endurance, aerobic capacity, flexibility, agility, and balance assessment. The test consist of 6 activities: 1. Arm Curl Test (number of forearm flexions in 30 seconds); 2. Back Scratch (the distance between middle fingers); 3. 30 Second Chair Stand (number of standings in 30 seconds); 4. Chair Sit-and-Reach ( '+' if fingers can reach toes in sitting position, '-' if fingers cannot reach toes in sitting position); 5. 8 - Foot Up-and-Go (8-foot walking time); 6. 2-Minute Step-in-Place (the number of lifts of the right leg).	First examination- before the start of the interventions
Primary	Physical performance assessment by Fullerton functional fitness test	The test comprising muscle endurance, aerobic capacity, flexibility, agility, and balance assessment. The test consist of 6 activities: 1. Arm Curl Test (number of forearm flexions in 30 seconds); 2. Back Scratch (the distance between middle fingers); 3. 30 Second Chair Stand (number of standings in 30 seconds); 4. Chair Sit-and-Reach ( '+' if fingers can reach toes in sitting position, '-' if fingers cannot reach toes in sitting position); 5. 8 - Foot Up-and-Go (8-foot walking time); 6. 2-Minute Step-in-Place (the number of lifts of the right leg).	Second examination- at the end of the 14-day rehabilitation program
Primary	Fatigue assessment using modified Borg scale	Fatigue will be examined during physical activity and the level of fatigue will be marked on a scale from 1 (no fatigue) to 10 (very very hard fatigue).	First examination- before the start of the interventions
Primary	Fatigue assessment using modified Borg scale	Fatigue will be examined during physical activity and the level of fatigue will be marked on a scale from 1 (no fatigue) to 10 (very very hard fatigue).	Second examination- at the end of the 14-day rehabilitation program
Primary	Fatigue assessment using modified Borg scale	Fatigue will be examined during physical activity and the level of fatigue will be marked on a scale from 1 (no fatigue) to 10 (very very hard fatigue).	Third examination - two months after discharge from the hospital (follow- up)
Primary	Dyspnea assessment with Medical Research Council dyspnea scale	Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).	First examination- before the start of the interventions
Primary	Dyspnea assessment with Medical Research Council dyspnea scale	Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).	Second examination- at the end of the 14-day rehabilitation program
Primary	Dyspnea assessment with Medical Research Council dyspnea scale	Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).	Third examination - two months after discharge from the hospital (follow- up)
Primary	Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)	Assessment of quality of life, health and other areas. The scale contains 26 items, divided into four domains: physical health (7 items), psychological health (6 items), social relations (3 items), and environmental health (8 items), as well overall quality of life and general health (2 items). Patients express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). The final score is transformed linearly to a 0-100-scale, where higher scores denote higher quality of life.	First examination- before the start of the interventions
Primary	Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)	Assessment of quality of life, health and other areas. The scale contains 26 items, divided into four domains: physical health (7 items), psychological health (6 items), social relations (3 items), and environmental health (8 items), as well overall quality of life and general health (2 items). Patients express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). The final score is transformed linearly to a 0-100-scale, where higher scores denote higher quality of life.	Second examination- at the end of the 14-day rehabilitation program
Primary	Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)	Assessment of quality of life, health and other areas. The scale contains 26 items, divided into four domains: physical health (7 items), psychological health (6 items), social relations (3 items), and environmental health (8 items), as well overall quality of life and general health (2 items). Patients express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). The final score is transformed linearly to a 0-100-scale, where higher scores denote higher quality of life.	Third examination - two months after discharge from the hospital (follow- up)
Primary	Anxiety and depression assessment using HADS scale	The scale consists of 16 statements to which the respondent refers on a four-point scale. Eight statements are used to measure anxiety and depression, each of which is rated on a scale of 0 to 3 points. The cut-off threshold is 7 points for depression and 7 points for anxiety. The intensity of depressed mood and anxiety will be analyzed.	First examination- before the start of the interventions
Primary	Anxiety and depression assessment using HADS scale	The scale consists of 16 statements to which the respondent refers on a four-point scale. Eight statements are used to measure anxiety and depression, each of which is rated on a scale of 0 to 3 points. The cut-off threshold is 7 points for depression and 7 points for anxiety. The intensity of depressed mood and anxiety will be analyzed.	Second examination- at the end of the 14-day rehabilitation program
Primary	Anxiety and depression assessment using HADS scale	The scale consists of 16 statements to which the respondent refers on a four-point scale. Eight statements are used to measure anxiety and depression, each of which is rated on a scale of 0 to 3 points. The cut-off threshold is 7 points for depression and 7 points for anxiety. The intensity of depressed mood and anxiety will be analyzed.	Third examination - two months after discharge from the hospital (follow- up)
Primary	Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale	Life independence test, i.e. ensuring the functioning of the household by a sick person based on his/her ability to cope in the external environment or with a complex activity such as using the telephone and ensuring the related opportunities. The ability of basic functioning in the environment will be analyzed and each of 8 items will be rate trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the eight responses. The final total score ranges from 8 (low functioning, dependent) to 24 (high function, independent).	First examination- before the start of the interventions
Primary	Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale	Life independence test, i.e. ensuring the functioning of the household by a sick person based on his/her ability to cope in the external environment or with a complex activity such as using the telephone and ensuring the related opportunities. The ability of basic functioning in the environment will be analyzed and each of 8 items will be rate trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the eight responses. The final total score ranges from 8 (low functioning, dependent) to 24 (high function, independent).	Second examination- at the end of the 14-day rehabilitation program
Primary	Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale	Life independence test, i.e. ensuring the functioning of the household by a sick person based on his/her ability to cope in the external environment or with a complex activity such as using the telephone and ensuring the related opportunities. The ability of basic functioning in the environment will be analyzed and each of 8 items will be rate trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the eight responses. The final total score ranges from 8 (low functioning, dependent) to 24 (high function, independent).	Third examination - two months after discharge from the hospital (follow- up)