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

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT02257463

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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)	Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations Other Names: uniphyllin, foradil, spiriva, miflonide Other: peripheral muscles exercise training Device: 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. Other Names: Threshold® Inspiratory Muscle Trainer, Healthscan, New Jersey, NJ, USA
Active Comparator: 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)	Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations Other Names: uniphyllin, foradil, spiriva, miflonide Other: peripheral muscles exercise training
Active Comparator: 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	Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations Other Names: uniphyllin, foradil, spiriva, miflonide

Arm

Intervention/Treatment

Active Comparator: 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)

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

Other Names:

uniphyllin, foradil, spiriva, miflonide

Other: peripheral muscles exercise training

Device: 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.

Other Names:

Threshold® Inspiratory Muscle Trainer, Healthscan, New Jersey, NJ, USA

Active Comparator: control positive group (group B)

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

Other Names:

uniphyllin, foradil, spiriva, miflonide

Other: peripheral muscles exercise training

Active Comparator: 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

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

Other Names:

uniphyllin, foradil, spiriva, miflonide

Outcome Measures

Primary Outcome Measures

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
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts 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