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This clinical trial aims to assess the effectiveness of home-based pulmonary rehabilitation in improving the clinical outcomes of patients with COPD.
Research questions :
RQ1: Is there a significant difference in the exacerbation rates before and after implementing the program? RQ2: Is there a significant improvement in the quality of life before and after implementing the program? RQ3: Is there a significant improvement in 6MWT before and after implementing the program? RQ4: Is there a significant improvement in COPD patients' modified Medical Research Council dyspnea scale before and after the implementation of the program?
Intervention group will receive pulmonary rehabilitation at home or any place they designated over eight consecutive weeks. Two sessions per week and continuous phone calls. Participants will also be given a structured manual to record their activities and follow instructions on days without supervision. While the control group receive routine care at the respiratory unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD | Experimental | 64 stable COPD patients receive eight week structured pulmonary rehabilitation program. Two session per week (1-2 hours) with continuous phon call. participants will be given structured manual. Primary outcomes are changes in the exacerbation rate, functional status and mMRC. Secondary outcomes are improvement in the health related quality of life and medication adherence with correct use of inhaler. To validate internal consistency all the outcomes will be compared with 64 patients in control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulmonary rehabilitation (PR) | Behavioral | PR is an exercise and education programme designed for people with lung disease who experience symptoms of breathlessness. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exacerbation rate | A COPD exacerbation, or flare-up, occurs when COPD respiratory symptoms become much more severe. | eight weeks after the implementation of the program |
| Functional status (exercise capacity) | The functional status is measured by the mean difference in the six minute walking distance (6MWD) | eight weeks after the program implementation |
| mMRC | modified Medical Research Council (mMRC) dyspnea scale is self-reported tool used to assess the severity of breathlessness and it's effect on the activity of daily living when the COPD patients is in the stable condition. The score of 0 demonstrates that the patient has the lowest breathlessness and no restriction to activities and the score of 4 shows that the patient has severe breathlessness and greatest impairment. | eight weeks after the program implementation |
| Measure | Description | Time Frame |
|---|---|---|
| CAT | The COPD Assessment Testâ„¢ (CAT) is a self-reported questionnaire that helps patients and healthcare professional to measure the impact that COPD (Chronic Obstructive Pulmonary Disease) is having on patients' wellbeing and daily life. The CAT score is the total of the scores from the eight assessed areas. The maximum score is 40 and it is categorized based on the severity as the follows. 0-9 low impact 0-20 medium impact 21-30 high impact 31-40 very high impact |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hawler Medical University | Erbil | Kurdistan | 44001 | Iraq |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Pre-post test will be adopted to assess the difference in the clinical outcomes of 64 staple patients with COPD after home-based pulmonary rehabilitation compared with 64 patients in control group.
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| eight weeks after the program implementation |
| Chronic Respiratory Questionnaire (CRQ) | The CRQ is a disease-specific health-related quality of life questionnaire, developed to measure the impact of Chronic Obstructive Pulmonary Disease (COPD) on a person's life. This tool is self-completed questionnaire, it has 20 items, 4 domains (Dyspnea, Fatigue, Emotional Function & Mastery). The scaling of items is 7-pointing modified Likert Scale (1-7) and 0-7 on dyspnea domain. Higher score indicates better quality of life. | eight weeks after the program implementation |
| Medication adherence assessment with MARS-5 | The MARS-5 Item Questionnaire The MARS-5 questionnaire consists of five questions on forgetting, changing dosage, stopping, skipping, and taking less medication. The score ranges from 5 to 25, where a higher MARS-5 score indicates higher self-reported adherence. One item assesses unintentional non-adherence and four items assess intentional non-adherence. | eight weeks after the program implementation |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |