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Clinical Trials/NCT02257463
NCT02257463
Completed
N/A

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

Mansoura University0 sites60 target enrollmentOctober 2011

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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
April 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

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