Chronic Obstructive Pulmonary DiseaseNCT06028711
Education Impact on Rehabilitation of Hospitalized Patients with Chronic Obstructive Pulmonary Disease.
A study testing Education program and Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by University of Rzeszow at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Education program and Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 28 Jul 2023to 7 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Education on the Rehabilitation of Patients Hospitalized Due to Chronic Obstructive Pulmonary Disease.
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.
Read the 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
- Being tested
- Education program, Pulmonary rehabilitation
- Keywords
- pulmonary rehabilitation, COPD patients' education
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education programOther
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 rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Education program and Pulmonary rehabilitation | Experimental | Conventional pulmonary rehabilitation coupled with original education program. Receives: Other: Education program; Other: Pulmonary rehabilitation |
| Pulmonary rehabilitation | Other | Conventional pulmonary rehabilitation Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: First examination- before the start of the interventions
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].
Measured: Second examination- at the end of the 14-day rehabilitation program
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.
Measured: First examination- before the start of the interventions
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.
Measured: Second examination- at the end of the 14-day rehabilitation program
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).
Measured: First examination- before the start of the interventions
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).
Measured: Second examination- at the end of the 14-day rehabilitation program
Pulse rate
Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.
Measured: First examination- before the start of the interventions
Pulse rate
Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.
Measured: Second examination- at the end of the 14-day rehabilitation program
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).
Measured: First examination- before the start of the interventions
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).
Measured: Second examination- at the end of the 14-day rehabilitation program
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.
Measured: First examination- before the start of the interventions
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.
Measured: Second examination- at the end of the 14-day rehabilitation program
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).
Measured: First examination- before the start of the interventions
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).
Measured: Second examination- at the end of the 14-day rehabilitation program
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).
Measured: First examination- before the start of the interventions
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).
Measured: Second examination- at the end of the 14-day rehabilitation program
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).
Measured: Third examination - two months after discharge from the hospital (follow- up)
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).
Measured: First examination- before the start of the interventions
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).
Measured: Second examination- at the end of the 14-day rehabilitation program
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).
Measured: Third examination - two months after discharge from the hospital (follow- up)
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.
Measured: First examination- before the start of the interventions
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.
Measured: Second examination- at the end of the 14-day rehabilitation program
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.
Measured: Third examination - two months after discharge from the hospital (follow- up)
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.
Measured: First examination- before the start of the interventions
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.
Measured: Second examination- at the end of the 14-day rehabilitation program
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.
Measured: Third examination - two months after discharge from the hospital (follow- up)
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).
Measured: First examination- before the start of the interventions
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).
Measured: Second examination- at the end of the 14-day rehabilitation program
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).
Measured: Third examination - two months after discharge from the hospital (follow- up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start28 Jul 2023
- Primary completion2 Sep 2024
- Study completion7 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- random selection to two groups (study group and control group)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renata Borys, University of Rzeszow
- Investigators
- Renata Borys, MSc, Principal investigator, University of RzeszowAgnieszka Guzik, A/Prof., Study director, University of RzeszowMagdalena Kołodziej, PhD, Study chair, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028711
- Sponsor's protocol ID
- URzeszow/2023/06/0034/W
- Status last verified
- Oct 2024
- First submitted
- 25 Aug 2023
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Education on the Rehabilitation of Patients Hospitalized Due to Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT06028711
- Acronym / sponsor ID
- URzeszow/2023/06/0034/W
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- pulmonary rehabilitation, COPD patients' education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 2 Sep 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- random selection to two groups (study group and control group)
| Arm | Type | Receives |
|---|---|---|
| Education program and Pulmonary rehabilitation | Experimental | Other: Education program, Other: Pulmonary rehabilitationConventional pulmonary rehabilitation coupled with original education program. |
| Pulmonary rehabilitation | Other | Other: Pulmonary rehabilitationConventional pulmonary rehabilitation |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education programPatients 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. | Other | Education program and Pulmonary rehabilitation |
| Pulmonary rehabilitationThe 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. | Other | Education program and Pulmonary rehabilitation, Pulmonary rehabilitation |
Primary outcome
Dynamic lung capacities (spirometry)
Time frame: First examination- before the start of the interventions
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)
Time frame: Second examination- at the end of the 14-day rehabilitation program
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)
Time frame: First examination- before the start of the interventions
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)
Time frame: Second examination- at the end of the 14-day rehabilitation program
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
Time frame: First examination- before the start of the interventions
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
Time frame: Second examination- at the end of the 14-day rehabilitation program
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
Time frame: First examination- before the start of the interventions
Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.
Pulse rate
Time frame: Second examination- at the end of the 14-day rehabilitation program
Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.
Acid-base balance
Time frame: First examination- before the start of the interventions
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
Time frame: Second examination- at the end of the 14-day rehabilitation program
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)
Time frame: First examination- before the start of the interventions
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)
Time frame: Second examination- at the end of the 14-day rehabilitation program
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
Time frame: First examination- before the start of the interventions
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
Time frame: Second examination- at the end of the 14-day rehabilitation program
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
Time frame: First examination- before the start of the interventions
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
Time frame: Second examination- at the end of the 14-day rehabilitation program
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
Time frame: Third examination - two months after discharge from the hospital (follow- up)
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
Time frame: First examination- before the start of the interventions
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
Time frame: Second examination- at the end of the 14-day rehabilitation program
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
Time frame: Third examination - two months after discharge from the hospital (follow- up)
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)
Time frame: First examination- before the start of the interventions
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)
Time frame: Second examination- at the end of the 14-day rehabilitation program
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)
Time frame: Third examination - two months after discharge from the hospital (follow- up)
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
Time frame: First examination- before the start of the interventions
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
Time frame: Second examination- at the end of the 14-day rehabilitation program
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
Time frame: Third examination - two months after discharge from the hospital (follow- up)
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
Time frame: First examination- before the start of the interventions
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
Time frame: Second examination- at the end of the 14-day rehabilitation program
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
Time frame: Third examination - two months after discharge from the hospital (follow- up)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renata Borys, MSc principal investigator
University of Rzeszow
Agnieszka Guzik, A/Prof. study director
University of Rzeszow
Magdalena Kołodziej, PhD study chair
University of Rzeszow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education program and Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by University of Rzeszow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic lung capacities (spirometry) (time frame: First examination- before the start of the interventions). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.