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

NCT ID: NCT02257463

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-04-30

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

peripheral muscles exercise training

Intervention Type: OTHER

inspiratory muscle training

Intervention Type: 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.

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)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

peripheral muscles exercise training

Intervention Type: OTHER

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

Interventions

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

Intervention Type: DRUG

peripheral muscles exercise training

Intervention Type: OTHER

inspiratory muscle training

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.

Intervention Type: DEVICE

Other Intervention Names

uniphyllin, foradil, spiriva, miflonide; Threshold® Inspiratory Muscle Trainer, Healthscan, New Jersey, NJ, USA

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
• Patients with advanced liver diseases, or renal impairment.
• Known connective tissue diseases
• Significant endocrinal abnormalities

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Dina Aboelkhair Abdallah

assistant lecturer in chest medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed S Elmorsi, MD

Role: STUDY_CHAIR

Mansoura University

Mohamad E Eldesoky, MD

Role: STUDY_DIRECTOR

Mansoura University

Mona AA Mohsen, MD

Role: STUDY_DIRECTOR

Mansoura University

Nesrien M Shalaby, MD

Role: STUDY_DIRECTOR

Mansoura University

Dina A Abdallah, MSc

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Other Identifiers

MD/4

Identifier Type: -

Identifier Source: org_study_id