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

Mansoura University

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02257463

MD/4

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Male

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Study group (group A)

Active Comparator group

Description:

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)

Treatment:

Other: peripheral muscles exercise training

Device: inspiratory muscle training

Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations

control positive group (group B)

Active Comparator group

Description:

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)

Treatment:

Other: peripheral muscles exercise training

Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations

control negative group (group C)

Active Comparator group

Description:

pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations

Treatment:

Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations