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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Education program
Pulmonary rehabilitation
Sponsored by
University of Rzeszow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring pulmonary rehabilitation, COPD patients' education

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Rzeszów

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Education program and Pulmonary rehabilitation

Pulmonary rehabilitation

Arm Description

Conventional pulmonary rehabilitation coupled with original education program.

Conventional pulmonary rehabilitation

Outcomes

Primary Outcome Measures

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].
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].
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.
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.
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).
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).
Pulse rate
Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.
Pulse rate
Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.
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).
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).
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.
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.
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).
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).
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).
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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).
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).
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).

Secondary Outcome Measures

Full Information

First Posted
August 25, 2023
Last Updated
August 31, 2023
Sponsor
University of Rzeszow
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1. Study Identification

Unique Protocol Identification Number
NCT06028711
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rzeszow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
pulmonary rehabilitation, COPD patients' education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
random selection to two groups (study group and control group)
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education program and Pulmonary rehabilitation
Arm Type
Experimental
Arm Description
Conventional pulmonary rehabilitation coupled with original education program.
Arm Title
Pulmonary rehabilitation
Arm Type
Other
Arm Description
Conventional pulmonary rehabilitation
Intervention Type
Other
Intervention Name(s)
Education program
Intervention Description
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
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dynamic lung capacities (spirometry)
Description
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].
Time Frame
First examination- before the start of the interventions
Title
Dynamic lung capacities (spirometry)
Description
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].
Time Frame
Second examination- at the end of the 14-day rehabilitation program
Title
Modified Tiffeneau-Pinelli index (spirometry)
Description
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.
Time Frame
First examination- before the start of the interventions
Title
Modified Tiffeneau-Pinelli index (spirometry)
Description
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.
Time Frame
Second examination- at the end of the 14-day rehabilitation program
Title
Oxygen saturation
Description
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).
Time Frame
First examination- before the start of the interventions
Title
Oxygen saturation
Description
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).
Time Frame
Second examination- at the end of the 14-day rehabilitation program
Title
Pulse rate
Description
Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.
Time Frame
First examination- before the start of the interventions
Title
Pulse rate
Description
Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.
Time Frame
Second examination- at the end of the 14-day rehabilitation program
Title
Acid-base balance
Description
The gasometry results will be taken from patients' medical documentation. The parameters analyzed will be oxygen pressure (pO2) and carbon dioxide pressure (pCO2).
Time Frame
First examination- before the start of the interventions
Title
Acid-base balance
Description
The gasometry results will be taken from patients' medical documentation. The parameters analyzed will be oxygen pressure (pO2) and carbon dioxide pressure (pCO2).
Time Frame
Second examination- at the end of the 14-day rehabilitation program
Title
Exercise tolerance assessed by 6-minute walking test (6MWT)
Description
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.
Time Frame
First examination- before the start of the interventions
Title
Exercise tolerance assessed by 6-minute walking test (6MWT)
Description
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.
Time Frame
Second examination- at the end of the 14-day rehabilitation program
Title
Physical performance assessment by Fullerton functional fitness test
Description
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).
Time Frame
First examination- before the start of the interventions
Title
Physical performance assessment by Fullerton functional fitness test
Description
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).
Time Frame
Second examination- at the end of the 14-day rehabilitation program
Title
Fatigue assessment using modified Borg scale
Description
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).
Time Frame
First examination- before the start of the interventions
Title
Fatigue assessment using modified Borg scale
Description
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).
Time Frame
Second examination- at the end of the 14-day rehabilitation program
Title
Fatigue assessment using modified Borg scale
Description
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).
Time Frame
Third examination - two months after discharge from the hospital (follow- up)
Title
Dyspnea assessment with Medical Research Council dyspnea scale
Description
Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).
Time Frame
First examination- before the start of the interventions
Title
Dyspnea assessment with Medical Research Council dyspnea scale
Description
Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).
Time Frame
Second examination- at the end of the 14-day rehabilitation program
Title
Dyspnea assessment with Medical Research Council dyspnea scale
Description
Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).
Time Frame
Third examination - two months after discharge from the hospital (follow- up)
Title
Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
Description
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.
Time Frame
First examination- before the start of the interventions
Title
Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
Description
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.
Time Frame
Second examination- at the end of the 14-day rehabilitation program
Title
Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
Description
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.
Time Frame
Third examination - two months after discharge from the hospital (follow- up)
Title
Anxiety and depression assessment using HADS scale
Description
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.
Time Frame
First examination- before the start of the interventions
Title
Anxiety and depression assessment using HADS scale
Description
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.
Time Frame
Second examination- at the end of the 14-day rehabilitation program
Title
Anxiety and depression assessment using HADS scale
Description
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.
Time Frame
Third examination - two months after discharge from the hospital (follow- up)
Title
Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale
Description
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).
Time Frame
First examination- before the start of the interventions
Title
Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale
Description
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).
Time Frame
Second examination- at the end of the 14-day rehabilitation program
Title
Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale
Description
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).
Time Frame
Third examination - two months after discharge from the hospital (follow- up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renata Borys, MSc
Phone
+48 784 016 220
Email
rborys@ur.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Magdalena Kołodziej, PhD
Phone
+ 48 794 244 063
Email
mkolodziej@ur.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata Borys, MSc
Organizational Affiliation
University of Rzeszów
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Agnieszka Guzik, A/Prof.
Organizational Affiliation
University of Rzeszów
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Magdalena Kołodziej, PhD
Organizational Affiliation
University of Rzeszów
Official's Role
Study Chair
Facility Information:
Facility Name
University of Rzeszów
City
Rzeszów
ZIP/Postal Code
35-959
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renata Borys, MSc
Phone
+48 784 016 220
Email
rborys@ur.edu.pl

12. IPD Sharing Statement

Learn more about this trial

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

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