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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02257463
• Other study ID #: MD/4
• Status: Completed
• Phase: N/A
• First received: September 26, 2014
• Last updated: April 7, 2015
• Start date: October 2011
• Est. completion date: April 2014

Study information

• Verified date: October 2014
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Mansoura University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in respiratory muscle strength	maximal inspiratory pressure, maximal expiratory pressure	after 4 weeks and after 8 weeks of study	No
Primary	changes in perception of dyspnea	modified Medical Research Council and modified Borg category scale	after 4 weeks and after 8 weeks of study	No
Primary	changes in exercise performance	6-min walk test	after 4 weeks and after 8 weeks of study	No
Primary	changes in quality of life	BODE index, St. George's Respiratory Questionnaire for COPD patients (SGRQ-C)	after 4 weeks and after 8 weeks of study	No