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The aim is to study effectiveness of inspiratory muscle training as a part of exercise training in patients with Chronic Obstructive Pulmonary Disease (COPD) and if it adds to general exercise training program in regard to respiratory muscle strength, dyspnea, exercise performance and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group (group A) | Active Comparator | pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training) inspiratory muscle training: (at intensity that progressively increased from 30% to 60% of patients' maximal inspiratory pressure) |
|
| control positive group (group B) | Active Comparator | pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training) |
|
| control negative group (group C) | Active Comparator | pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in respiratory muscle strength | maximal inspiratory pressure, maximal expiratory pressure | after 4 weeks and after 8 weeks of study |
| changes in perception of dyspnea | modified Medical Research Council and modified Borg category scale | after 4 weeks and after 8 weeks of study |
| changes in exercise performance | 6-min walk test | after 4 weeks and after 8 weeks of study |
| changes in quality of life | BODE index, St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) | after 4 weeks and after 8 weeks of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed S Elmorsi, MD | Mansoura University | Study Chair |
| Mohamad E Eldesoky, MD | Mansoura University | Study Director |
| Mona AA Mohsen, MD | Mansoura University | Study Director |
| Nesrien M Shalaby, MD | Mansoura University | Study Director |
| Dina A Abdallah, MSc | Mansoura University | Principal Investigator |
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|
| peripheral muscles exercise training | Other |
|
| inspiratory muscle training | Device | Patients started breathing at a resistance that required generation of 30% of their PImax for one week. The load was then increased incrementally, 5-10%, to reach generation of 60% of their PImax at the end of the first month. Specific IMT was then continued at 60% of their PImax adjusted weekly to the new PImax achieved. |
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|
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D013806 | Theophylline |
| D000068759 | Formoterol Fumarate |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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