Effect of Inspiratory Muscle Training on Exercise Performance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
Overview
- Phase
- N/A
- Intervention
- theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Mansoura University
- Enrollment
- 60
- Primary Endpoint
- changes in exercise performance
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Dina Aboelkhair Abdallah
assistant lecturer in chest medicine
Mansoura University
Eligibility Criteria
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
Arms & Interventions
Study group (group A)
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)
Intervention: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations
Study group (group A)
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)
Intervention: peripheral muscles exercise training
Study group (group A)
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)
Intervention: inspiratory muscle training
control positive group (group B)
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)
Intervention: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations
control positive group (group B)
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)
Intervention: peripheral muscles exercise training
control negative group (group C)
pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations
Intervention: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations
Outcomes
Primary Outcomes
changes in exercise performance
Time Frame: after 4 weeks and after 8 weeks of study
6-min walk test
changes in quality of life
Time Frame: after 4 weeks and after 8 weeks of study
BODE index, St. George's Respiratory Questionnaire for COPD patients (SGRQ-C)
changes in respiratory muscle strength
Time Frame: after 4 weeks and after 8 weeks of study
maximal inspiratory pressure, maximal expiratory pressure
changes in perception of dyspnea
Time Frame: after 4 weeks and after 8 weeks of study
modified Medical Research Council and modified Borg category scale