Effect of Inspiratory Muscle Training on Exercise Performance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Inspiratory Muscle Training on Exercise Performance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations
* Other: peripheral muscles exercise training
* Device: inspiratory muscle training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Exsmokers Low PImax compared to reference values [lower limits of normal: 80 cmH2O for patients less than or equal 54 years old; 71 cmH2O for patients' age between 55-64 years; and 65 cmH2O for patients 65 years old ]. Stable patients without history of exacerbation or hospitalization four weeks before starting the study. Exclusion Criteria: Lack of motivation and compliance. Patients with significant reversibility following bronchodilation defined as an increase in FEV1 of more than 12% and 200 ml from the pre-bronchodilator value Unstable cardiac disease [severe heart failure, dangerous dysrhythmias, recent myocardial infarction or unstable angina (within 4 weeks)]. Uncontrolled hypertension Recent pneumothorax (within 6 weeks) Recent abdominal or thoracic surgery (within 6 weeks) Known progressive neuromuscular disorders Recent gastrointestinal bleeding (within 4 weeks) Current smokers Active cancer Patients with advanced liver diseases, or renal impairment. Known connective tissue diseases Significant endocrinal abnormalities

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group (group A)<br>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) | Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations<br> <br> * Other names: uniphyllin, foradil, spiriva, miflonide;Other: peripheral muscles exercise training<br> <br> Device: inspiratory muscle training<br>* 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.<br>* Other names: Threshold® Inspiratory Muscle Trainer, Healthscan, New Jersey, NJ, USA;|
| Active Comparator: control positive group (group B)<br>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) | Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations<br> <br> * Other names: uniphyllin, foradil, spiriva, miflonide;Other: peripheral muscles exercise training<br> <br> |
| Active Comparator: control negative group (group C)<br>pharmacologic treatment: theophylline uniphyllin, long acting bronchodilators foradil/spiriva or combined LABD and inhaled steroids miflonide according to GOLD recommendations | Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations<br> <br> * Other names: uniphyllin, foradil, spiriva, miflonide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, inspiratory muscle training, dyspnea, Quality of Life