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

Information source: Mansoura University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

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

Phase: N/A

Status: Completed

Sponsored by: Mansoura University

Official(s) and/or principal investigator(s):
Ahmed S Elmorsi, MD, Study Chair, Affiliation: Mansoura University
Mohamad E Eldesoky, MD, Study Director, Affiliation: Mansoura University
Mona AA Mohsen, MD, Study Director, Affiliation: Mansoura University
Nesrien M Shalaby, MD, Study Director, Affiliation: Mansoura University
Dina A Abdallah, MSc, Principal Investigator, Affiliation: Mansoura University

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome:

changes in respiratory muscle strength

changes in perception of dyspnea

changes in exercise performance

changes in quality of life

Eligibility

Minimum age: 45 Years. Maximum age: 65 Years. Gender(s): Male.

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

Locations and Contacts

Additional Information

Starting date: October 2011
Last updated: April 7, 2015

Page last updated: August 23, 2015

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