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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: 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

• Registration Number: NCT02257463
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2014-09-26
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-03
• Study First Posted: 2014-10-06
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group (group A)	peripheral muscles exercise training	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)	theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations	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 positive group (group B)	peripheral muscles exercise training	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)	theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations	pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations
Study group (group A)	theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations	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)
Study group (group A)	inspiratory muscle training	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)

Primary Outcome Measures

Name	Time	Method
changes in exercise performance	after 4 weeks and after 8 weeks of study	6-min walk test
changes in quality of life	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	after 4 weeks and after 8 weeks of study	maximal inspiratory pressure, maximal expiratory pressure
changes in perception of dyspnea	after 4 weeks and after 8 weeks of study	modified Medical Research Council and modified Borg category scale