An interventional study of Education program and Pulmonary rehabilitation in Chronic Obstructive Pulmonary Disease, sponsored by University of Rzeszow. Completed at 1 site in Poland. Open to participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by University of Rzeszow · Not applicable, Interventional, and Treatment
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.
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:
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Exclusion Criteria:
Conventional pulmonary rehabilitation coupled with original education program.
Other: Education program · Other: Pulmonary rehabilitation
Conventional pulmonary rehabilitation
Other: Pulmonary rehabilitation
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.
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.
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 \[L\].
Time frame: 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 \[L\].
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Third examination - two months after discharge from the hospital (follow- up)
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University of Rzeszow